http://www.novonordisk-jobs.com/feeds/medical-reviewer-job-description/ Custom RSS Feed for medical-reviewer-job-description Thu, 23 May 2013 21:32:56 GMT en-us /sites/novonordisk/images/Novo_Banner.gif http://www.novonordisk-jobs.com/feeds/medical-reviewer-job-description/ 720 Title Medical Director
Job Category Medical
Job Description PURPOSE:

Assist the Sr. Medical Director in developing and implementing the medical affairs strategy for a particular brand within Diabetes. Coordinate medical activities linked to the Brand in conjunction with the Sr. Medical Director. Assist the Sr. Medical Director in managing the program for phase 3b/4 clinical trials program, defining strategies to support medical education programs, reviewing medical and scientific content of promotional materials, maintaining KOL relationships and serving as a consultant for Marketing, FMA, MC&G and Sales. Assist with the development of strategies to appropriately position the Brand as part of the Novo Nordisk portfolio within the continuum of diabetes care. Review the representation of medical affairs in promotional review board (PRB) activities.

RELATIONSHIPS:

This position reports directly to the Sr. Medical Director, Medical Affairs – Diabetes and will assist the Sr. Medical Director in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. External relationships include expert advisory board members, investigators, other consultants, and key customer groups. Assist in driving the Brand’s Project House Team. Contribute to the Brand’s PPG and EBT.

ESSENTIAL FUNCTIONS:

COMMUNICATIONS/TRAINING: Assists in the review of educational curricula to effectively teach and assist in the training of sales representative, Drug Information specialists, Field Medical Affairs, and Investigators

In conjunction with the Sr. Medical Director may serve as a representative of Novo Nordisk Inc. Medical department in regulatory interactions, investigators’ and expert advisory board meetings, external professional societies, seminars, and conventions

Maintains required credentials and remains in good standing within the medical community and medical ethics boards

Stays abreast of regulatory requirements and guidelines and current trends and medical practice in the field of endocrinology and diabetes, including reports and intelligence on new technologies or treatment advances

MEDICAL COMMUNICATIONS: Assists in developing brand-specific medical education strategy (CME, medical grants, AMCs/professional societies) incorporate into 5 year plans and assess impact

Assists in the development of brand-specific publications strategy (primary, secondary and HEOR), with input from Medical Operations, and Global Publications.

Assists the Director of Medical Education in overseeing NNI support to external medical educations programs

Provides medical input to manuscripts based on clinical trial results and on general diabetes topics

Reviews all brand-specific promotional materials (finalized medical input for PRB)

Supports Medical Information and Field Medical Affairs units

REGULATORY AND SAFETY ACTIVITIES: Assists in assuring the ongoing safety and adequacy of labeling of the Brand from a medical perspective

Assists in the interpretation of regulatory guidelines and directives to judge risk and causality

Assists the Sr. Medical Director in ensuring quality execution by collaborating closely with CTM and FMA in selection investigators/sites, ensuring screening and accuracy, and guiding interpretation.

Assumes primary accountability as representative in Promotional Review Board (PRB) activities. This role requires full knowledge of diabetes product portfolio and understanding of various Federal and Pharma regulations and guidelines as well as in depth knowledge of diabetes disease state.

Supports the definition and implementation of the Brand’s labeling strategy.

SALES AND MARKETING SUPPORT: Assists the Sr. Medical Director in presenting the Brand’s clinical data at regional and national advisory boards

Assists the Sr. Medical Director in providing medical input to the Brand’s market shaping strategy, marketing plans and promotional campaigns

Participates in advisory boards, speaker training, Medical Marketing meetings, and other marketing activities as needed

Participates in the development of medical product support and development plans for the Brand in concert with Sales and Marketing

Supports ongoing sales and marketing objectives by assisting the Sr. Medical Director in making presentations as appropriate to external groups such as academic and community medical departments, professional associations, and P&T committees

Works closely with Medical Information to assure that communication from Novo Nordisk is scientifically accurate and clinically appropriate

STRATEGY AND PROTOCOL DEVELOPMENT: Assist the Sr. Medical Director in developing and executing brand–specific phase 3b/4 trial strategy including prioritization criteria, with input from Marketing and Global, and incorporate into annual and five-year plans, formalizing template and process to streamline protocol design, and developing brand-specific IIS strategy, including prioritization criteria, and support its execution.

Assists Sr. Medical Director in providing NNI medical input on the Brand’s global clinical development plan.

Collaborate closely with HEOR group on brand-related activities (providing input into early economic models/endpoints for phase 1-3, phase 3b/4, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications)

In collaboration with the Sr. Medical Director, build relationships and maintain a strong KOL network

Participate in Medical Marketing discussions regarding local and global clinical trials and assists with the preparation of Local Trial Proposal form as needed

Participates in global publication planning team for the brand, along with NNI Medical Operations.

Provide medical/scientific input into the Brand’s development and marketing strategies in consultation with the Sr. Medical Director

Provides content and ideas for publications run by Medical Operations.

Reviews brand-specific IIS proposals

PHYSICAL REQUIREMENTS:

Must be able to travel and work on weekends 20-30% of the time.

DEVELOPMENT OF PEOPLE:

Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

An MD or DO and 5 years’ experience, with clinical and prior direct patient care experience

Research or pharmaceutical industry experience in the field of endocrinology and metabolism preferred.

Strong strategic mindset, understanding of market needs, resource allocation, etc?

Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, IIS, med ed).

Subspecialty training in endocrinology and metabolism preferred
Department CMR - MEDICAL AFFAIRS DIABETES (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%]]>Thu, 25 Apr 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Medical-Director-Job-NJ-08540/2567595/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Medical-Director-Job-NJ-08540/2567595/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Executive Director - Hemostasis
Job Category Medical
Job Description To provide medical leadership including the assessment and support of product development and extension, and professional services for Biopharmaceutical marketed products.

RELATIONSHIPS:

This position reports to the Vice President, Clinical Development & Medical Affairs, BioPharm and manages the Clinical Development and Medical Affairs, Hemostasis Team. It is accountable for managing multiple internal relationships within NNI and NNAS. External relationships include working with the medical community and customers.

ESSENTIAL FUNCTIONS:

PROTOCOL DEVELOPMENT
•Conduct needs assessment for therapeutics in healthcare, the risks of intervention and the potential market for intervention.
•Review, refine, prioritize and manage the Hemostasis Clinical Trials Program.
•Develop medical affairs capabilities.
•Manage core project teams between NNI and NNAS to integrate clinical /medical core programs.
PRODUCT SUPPORT AND SAFETY
•Evaluate reports of adverse outcomes, apply clinical medical acumen and interpret regulatory guidelines and directives to judge risk and causality.
•Participate in meetings and the Promotional Review Board (PRB).
•Assure the ongoing safety and adequacy of labeling of NNI's marketed products from a medical perspective.

SALES AND MARKETING
•Provide medical input to marketing plans, promotional campaigns and new product launch platforms.

PRODUCT DISCOVERY AND DEVELOPMENT
•Coordinate Medical Department strategic review of in-licensing candidates and external development projects for NNI’s existing in-line product franchises.

MEDICAL AND PATIENT COMMUNITY
•Must have (and continue to build) relationships with key thought leaders in the hemophilia community.

•Develop educational curricula to effectively teach.
•Serve as an expert in hematology.
•Maintain necessary credentials and remains in good standing within the medical community and medical ethics boards.

DEVELOPMENT OF PEOPLE:
•Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
•Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way •Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
•MD and 5 plus years Industry experience. Pharmaceutical development or
research experience, including expertise in clinical trial methodology and medical product support, and medical affairs.
•Hematology experience specializing in bleeding disorders is required.

•Experience in development and regulatory areas required.
•Previous supervisory experience required.
•Administrative responsibilities in an institutionalized setting required.
•Must maintain necessary credentials and remain in good standing within the medical community and medical ethics boards.
•Previous Phase I-IIIB and IV clinical trials experience required.
•Some clinical and previous patient care experience required.
•Strategic/Tactical planning experience within a pharmaceutical environment is required.
•Able to assess a clinical outcome and relate it to a drug.
Department CMR - HEMOSTASIS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 30 - 40%]]>Tue, 21 May 2013 07:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Executive-Director-Hemostasis-Job-NJ-08540/1786584/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Executive-Director-Hemostasis-Job-NJ-08540/1786584/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Sr. Manager/Associate Director,Regulatory Affairs - Promotional Review
Job Description PURPOSE:

Manage the Regulatory review of Promotions and Advertisements for company marketed products.

RELATIONSHIPS:

Reports to the Director, Promotional Review. Works with other personnel in Marketing ,Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of initiatives and Promotional Review Board (PRB) process and review of promotional materials. External relationships include interaction with FDA personnel regarding promotional issues. Develop and maintain positive rapport and working relationships within and across departments, including Marketing, in relation to promotional issues. Manages assigned junior personnel as direct reports. Attend FDA’s meetings and contribute to negotiations with FDA as necessary.

ESSENTIAL FUNCTIONS:

FDA COMPLIANCE:

Assure full regulatory compliance of all promotions with approved labeling.

Handle other duties and/or special projects as assigned by the Director/VP, Regulatory Affairs.

Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices. Advise appropriate departments within the company (NNI and NNAS) of these requirements. Assist the Director in establishing procedures to assure compliance with these requirements.

Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk.

Review of draft and final advertising/promotional materials for marketed products, as assigned.
Coordinate and supervise the development of regulatory strategies for investigational, new or modified pharmaceutical products.
Approve specified regulatory submissions

PRB PROCESS:

Assist the Director in development and implementation of strategy to maintain efficient and compliant PRB process.

Builds a strong relationship with internal customers; including Marketing, Marketing Operations, Legal and Medical.

Builds a strong relationship with the FDA

Other duties as deemed appropriate by Director, PRB.

Provide regulatory review of draft promotional materials (pre-PRB).

Regulatory PRB reviewer.

Support development of launch materials/new claims by collaborating with Marketing, Medical and Legal. Prepare FDA submissions of draft introductory promotional materials.

SUBMISSIONS:

Assure company compliance with FDA and FTC requirements and strategy.

Ensure timely and accurate submission of promotional materials to FDA in Form 2253.

Oversee preparation and submission of draft introductory materials to FDA for comment.

PHYSICAL REQUIREMENTS:

Some travel required.

DEVELOPMENT OF PEOPLE:

Ensure that reporting personnel have 3P forms, which have annual goals and measurements, are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities. Understand their level of accountability for results and the measurement process.

Ensure that the IDP forms (reporting personnel and own) include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.

Review subordinates 3P and IDP’s.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A Bachelors Life Science degree required; advanced degree preferred.

A minimum of eight (8) years pharmaceutical industry experience, including direct FDA Regulatory Affairs interaction (submissions and negotiations).

A minimum of two (2) years Regulatory Promotional Review experience required.

Detail & deadline oriented; well organized.

Excellent verbal & written communication skills.

Good interpersonal skills; ability to interact with staff on all levels.

Works independently with minimal supervision.
Department CMR - PROMOTIONAL REVIEW
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%]]>Wed, 22 May 2013 07:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Manager%2C-Regulatory-Affairs-Promotional-Review-Job-NJ-08540/2224770/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Manager%2C-Regulatory-Affairs-Promotional-Review-Job-NJ-08540/2224770/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Senior Manager - Medical Affairs - Scientific Strategy
Job Category Field Medical
Job Description PURPOSE:

This position will develop scientific resources, communication and training materials for the diabetes medical affairs (MA) team; and will work closely with the MA management team and other internal stakeholders such as Clinical, Medical Information, Marketing, Market Shaping, Sales Operations, and CMR Training to assist in the implementation of scientific initiatives focused on both internal and external customers. To ensure accurate, timely and current medical updates to scientific communications materials and resources in use by the MA team related to current and future diabetes treatment modalities and guidelines. Create, review, update and archive MA slide libraries, Field MA (FMA) clinical reading binders, new hire material, product-specific key studies and other material for use by medical professionals within Novo Nordisk. Serve as resource to the overall MA team in product and disease state scientific resources and education as directed by MA management. This position may focus on specific products and/or customer groups as determined by the business needs. Projects will be allocated across team members to optimize workflow and according to business priorities.

RELATIONSHIPS:

Position reports to the Associate Director, Medical Affairs Scientific Strategy & Communications. Additional key internal relationships include MA internal and field management, MA project management, Medical Communications, CMR Training, Clinical Trial Management, Clinical Development, Marketing and Market Shaping.

ESSENTIAL FUNCTIONS:

• Act as a scientific resource for the MA team.
• Act as a scientific resource liaison between FMA team and Field Medical Canada, BioPharm, Medical Education and Medical Information Departments.
• Act as point person to represent the MA team to liaise with key internal stakeholders cross-functionally on appropriate projects
• Assist home office medical strategy & operations (MSO) team in responding accurately and timely to scientific information requests from the MA team.
• Assist home office Scientific Strategy & Communications team in the coordination and training of sales representatives on disease state knowledge as requested.
• Assist in preparation and implementation of MA scientific training initiatives in collaboration with CMR Training. This includes new hire scientific training, ongoing scientific training (Tele/Web-conferences or live training at Regional and National meetings) and other initiatives to ensure MA Team members have the most current medical and scientific information and “best in class” clinical support.
• Assist MA team in preparing for major presentations or major managed care meetings as requested.
• Coordinate all FMA activities related to scientific conventions, work with FMA leadership team to identify and cover relevant scientific sessions, work with other departments to secure FMA personnel support at Novo Nordisk Medical Booths/lounges and for overall coordination.
• Coordinate with Clinical Strategy Director, Brand Medical Directors and with Competitive Intelligence teams for regular MA updates on ongoing and anticipated clinical trials in support of Novo Nordisk brands and those related to competitive products.
• Coordinate with Product Safety to provide relevant updates to FMA team
• Develop and maintain scientific knowledge database for the MA team.
• Keep the MA team updated on new information related to diabetes.
• Maintain and update the Diabetes Medical Slide Library for use by MA team.
• Partner closely with FMA Management Team, to ensure field management input and alignment on all initiatives.
• Prepare and communicate scientific material and clinical updates to the MA team on an ongoing basis and in advance of new data roll-out, new product launches, speaker training programs, and other venues as directed by MA management.
• Submit all medical slides and other scientific resources for appropriate medical and legal review to assure compliance with standardized review processes of materials used by professionals in the MA Team.

KEY SUCCESS FACTORS:

• PharmD preferred with a minimum of 3 years of academic or industry experience or doctoral degree (PharmD, PhD, MD or DO) with 2-3 years of Medical information/Affairs experience.
• Between 2 to 3 years of field medical experience strongly preferred.
• Demonstrated understanding of legal and regulatory environment of pharmaceutical industry.
• Possess superior communication skills, both oral, written and presentation, and ability to engender trust and respect of peers and superiors.
• Presentable, highly articulate, goal-oriented, honest, with high integrity and strong ethics.
• Proficiency in PowerPoint, Excel and MS word software applications and overall advanced computer skills with knowledge of literature search techniques required.
• Proven track record of strong team work, innovation, and project management
• Strong diabetes knowledge and keen understanding of diabetes therapeutics preferred.

PHYSICAL REQUIREMENTS:

Ability to drive to or fly to various meetings – approximately 15% overnight travel. Some international travel
may be required.
Department CMR - FMA SCIENCE
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 10 - 20%]]>Tue, 21 May 2013 05:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Senior-Manager-Medical-Affairs-Scientific-Strategy-Job-NJ-08540/2609790/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Senior-Manager-Medical-Affairs-Scientific-Strategy-Job-NJ-08540/2609790/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Principal Statistician/Assoc. Director - Biostatistics
Job Category Medical Information
Job Description PURPOSE:

This is a senior level technical position. Work under minimal supervision, the incumbent is responsible for the delivery of statistical support to NN's clinical development, registration, and marketing support programs. Functions include clinical trial design, data analysis, report writing, and general consultations. The scope of responsibility includes one or more drug development programs.

RELATIONSHIPS:

Reports to Director of Biostatistics. Through project team, works closely with clinicians, medical writers, data managers, regulatory managers, and marketing managers.

ESSENTIAL FUNCTIONS:

CLINICAL TRIAL DESIGN AND ANALYSIS: Under coordination of his/her supervisor, lead the statistics aspect of assigned clinical projects. Assure that statistical and scientific methodologies are fully considered and documented. Under minimum supervision, participate in the review of study protocols, critic and suggest improvement on scientific methodology, write statistical sections, develop plans and perform statistical analysis and presentation. Under guidance, participate in the interaction with medical development, medical writing, regulatory affair, and regulatory agencies. Assure statistical input, analysis, and reports of the highest quality are delivered according to schedule.

CUSTOMER MANAGEMENT: Under coordination of his/her supervisor, participate in meetings or communications with the regulatory agencies (primarily the FDA). Under minimum supervision, manage the relations with NNPI internal customers, including clinicians, medical writers, regulatory staff, and marketing managers.

QUALITY AND PROCEDURE IMPROVEMENT: Participate in the development and update of internal SOPs and working procedures. Assist the head of Biostatistics, lead the department staff keeping abreast with current statistical literature, assure the most current regulatory requirement are followed and sound methodologies are adopted. Keeping abreast and observe general guidance established in the pharmaceutical industry, including FDA guidelines, ICH guidelines, NN SOPs, and generally accepted GCP.

RESOURCE MANAGEMENT: Under coordination with his/her supervisor, prioritize task assignment, timelines, and outsourcing management. Manage the interactions with NNA/S headquarters statistical group through department Director.

STATISTICAL PROGRAMMING AND PRESENTATION: Perform hand-on programming or direct statistical programming staff assure that data listing, tables, and graphs are produced with highest efficiency and quality; Participate in the development and maintenance of statistical routine libraries.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A Ph.D. degree in biostatistics, statistics, or relevant areas required.
Six years of experience in pharmaceutical industry engaged in biostatistical support of clinical development with progressively increasing scope of responsibility.
Demonstrated ability to develop statistical methodology for analyses of clinical data.
Extensive knowledge of statistical computer programming skills.
Good communication and interpersonal skills.
Knowledge of regulatory requirement.
Knowledge of statistical concepts and techniques and of clinical trial principles.
Department CMR - BIOSTATISTICS & STAT PROG (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required]]>Sat, 18 May 2013 05:31:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Principal-Statistician-Assoc_-Director-Biostatistics-Job-NJ-08540/2557339/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Principal-Statistician-Assoc_-Director-Biostatistics-Job-NJ-08540/2557339/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Assoc. Director/Director, Health Economics Outcomes Research
Job Category Medical Information
Job Description PURPOSE:
The Associate Director/Director will be responsible and accountable for setting strategy for HEOR/value communication in collaboration with the brand leads/managed markets liaisons for the products throughout their lifecycle He/she will develop and implement US HEOR strategy for one or multiple therapeutic area(s) through personal research, consultants and internal stakeholders. He/she will design and perform health economic and outcome research projects/studies focusing on value, positioning and unmet needs of pipeline and newly launched Novo Nordisk products in order to support best possible market access.

The Associate Director/Director will be responsible for all aspects of effective project management, including RFP development, selection of research partners, contract execution, budget planning, protocol design, analytic plan development, oversight of data collection/acquisition, data analysis, and development of research findings into publications and into field resources/deliverables in alignment with brand and channel strategies.

The position will provide a lead in the initiation, development and implementation of world-class health economics and reimbursement strategies across assigned products. This is done under the direction of the Executive Director of Health Economics and Outcomes Research (HEOR).

This role will align HEOR strategies with Brand Marketing, Pricing and Contracting Operations (PCOR), Managed Market Sales, and Medical & Scientific Affairs. This is a technical position with project-specific strategic responsibilities. The incumbent is responsible for the delivery HEOR research in support of NNI projects in clinical development as well as for marketed products. This is a highly independent position sustained by the training, experience, and judgment of the incumbent. In addition, this position sets strategies with expertise in the design and application of economic/outcomes value research during all phases of product life cycles. Works in close collaboration with HEOR Field Managers in field execution of strategic research initiatives and represents Novo Nordisk with brand value discussions during customer presentations, contract negotiations, and at scientific conferences (international & domestic).

Through extensive interaction with MM Strategy and relevant Brand Marketing teams, this position will assist in building comprehensive value arguments to improve market access and utilization, thereby increasing product performance and achieving business goals and improving patient outcomes.

RELATIONSHIPS:

Reports to the Director or Executive Director, Health Economics and Outcomes Research and works closely with HQ and field HEOR colleagues and Managed Market Sales. Other home-office relationships include Customer Channel Directors, Brand Marketing teams, Medical Writers, PCOR members, and Medical personnel. Works closely with Global HEOR and Global Marketing colleagues in corporate headquarters. Field-based relationships include clinical and academic KOL relationships, consultants & vendors, and professional associations/conferences.

ESSENTIAL FUNCTIONS:
HEALTH ECONOMICS & OUTCOMES RESEARCH:

Acts as a HEOR champion to continually educate the organization on the latest developments and thinking in HEOR as it relates to Evidence Based Medicine, PRO regulatory processes, and reimbursement policies.

Acts as a home-office liaison and key contact point for HEOR/Managed Markets Strategy with Brand Marketing, Medical/Scientific Affairs, Medical Writing, and HEOR Field Managers.

Collaborates with home office and field-based Health Economics Managers in the execution of studies and implementation of field-based, customer-focused initiatives (e.g., models, presentations, publications, slide kits, formulary/regulatory dossiers).

Coordinates necessary US and global randomized and observational clinical data to create and include economic arguments.

Designs and develops pharmacoeconomic models, including decision analytic models, cost-effectiveness models, budget impact models and disease treatment models to support the market access and performance of Novo Nordisk portfolio brands.

Develops and/or coordinates the development of product dossiers.

Develops research plans, protocols and budgets, conducts analyses, and prepare drafts and final reports, abstracts, and manuscripts.

Identifies and maintains successful research relationships with HEOR key opinion leaders and other clinical/academic consultants.

Incorporates business requirements/concerns of top tier customers into analytic tools and results-focused approaches.

Leads the development of HEOR strategies and assist in creating tactics for economic value & quality of life arguments during product development and launch to support pricing and reimbursement across primary customer segments.

Provides additional internal training on HEOR methodologies and data results to Medical & Scientific Affairs and Brand Marketing colleagues.

Provides technical oversight and guidance to research and research support staff. Serve as an internal expert and key resource for research design, methodologies, analytic techniques and reporting of health economic and outcomes research.

Supports HQ HEOR staff in working with Global Marketing and Global Development within Novo Nordisk corporate offices to develop core value protocols.

Works closely with Medical Writers & HQ HE managers to ensure scientific conference material is appropriate, relevant and accurate.

Works with Medical Affairs to help influence Phase IV clinical trial design, inclusion of appropriate value endpoints/metrics, data analysis and publications, as appropriate.

PHYSICAL REQUIREMENTS:

Approximately 35 % overnight travel

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A PhD health economics, epidemiology, outcomes research, public health, business/health services research, biostatistics,

OR

PhD/MD/PharmD with an MPH with emphasis in the area(s) of health economics, epidemiology and/or outcomes research

OR

MPH with a focus in Epidemiology, health economics and/or outcomes research and at least 7 years demonstrated experience in HEOR.

At least 5 years (or as above, 7 years with MPH alone) of experience in health economics, outcomes research, pricing, reimbursement, and/or portfolio analysis, with at least 2-3 years in the pharmaceutical industry, preferably with focus in diabetes or chronic care

Advanced knowledge and experience in conducting health economics, health related quality of life, and/or health services research studies and the evaluation of health care interventions

Demonstrable record of peer-reviewed scientific publications, dossier development, and strategic, customer-focused HEOR tool development

Excellent process and project management skills required including the ability to manage a significant volume of projects with exercise of good triage and judgment skills

Experience in preparing or reviewing materials for drug formularies

In-depth knowledge of health care systems in the U.S., including managed care organizations, PBMs, Medicare, and Medicaid

Proven record of outstanding written and verbal communication and negotiation skills, with experience interacting with and presenting to key customers
Department CMR - HEOR (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 30 - 40%]]>Wed, 01 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Assoc_-Director-Director%2C-Health-Economics-Outcomes-Research-Job-NJ-08540/2574719/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Assoc_-Director-Director%2C-Health-Economics-Outcomes-Research-Job-NJ-08540/2574719/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title QAPS Area Specialist I
Job Category Quality
Job Description Position Purpose:
Ensures timely review and approval of production records that are compliant with all applicable regulations. Works closely with manufacturing to improve quality of the product and production processes.

Education: Bachelor’s Degree in Life Sciences, Engineering, Computer Science, or related field or equivalent combination of education and experience

Experience: 3+ years of QA or manufacturing experience in the pharmaceutical or medical device industry with progressively increasing responsibility.

Demonstrated experience leading in a matrixed environment and on cross-functional teams.

Technical/Process/Functional Knowledge:
?Demonstrated knowledge of critical controls and input/output requirements for processes in the semi-finished manufacturing area, finished manufacturing areas or process utility area.
?Demonstrated knowledge of US, EU regulations and guidelines, and application of GMP’s
?Excellent written and oral communication skills.
?Basic computer skills in MS Office, MS Project, etc.
?Ability to work day or evening shifts, as required
Preferred
?Scientific or Engineering undergraduate degree
?Thorough knowledge of cGMPs OR extensive pharmaceutical manufacturing experience
?Strong computer skills
?Familiarity with Six Sigma and LEAN tools

Physical/ Other Requirements
Ability to work 12 hour shifts or longer, day or night.
Ability to attain clean room gowning certification and work with hazardous materials including sanitants. (Aseptic Production)Ability to work hours necessary to support shift production.
Ability to travel internationally
Ability to achieve core gown certification (Aseptic Production)
Department QA Production Support - Team D
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree or equivalent experience
Shift Night]]>Thu, 09 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/clayton-QAPS-Area-Specialist-I-Job-NC-27520/2409367/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/clayton-QAPS-Area-Specialist-I-Job-NC-27520/2409367/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SR DIRECTOR - MARKET SHAPING
Job Category Marketing
Job Description PURPOSE:
• Accountable to lead the strategic direction of market shaping business plans across the entire diabetes portfolio. Develops and coordinates COE area strategies and tactics based on the overall brand/portfolio strategy. Acts as the functional expert in designated area. Acts as a leader and point person for strategic and tactical execution within designated functional area. Ensures alignment of all initiatives with brand strategies. Participates in some of the diabetes governance bodies (e. g. DOT (ad hoc), EBTs, MedMar/and leads the Extended Market Shaping team) to ensure market shaping strategy is aligned with the overall diabetes strategy.
• Interacts extensively with other functions within Novo Nordisk at senior levels – medical affairs and sales. Has leadership responsibility for a team of direct reports. Participates as an active member of the Diabetes Marketing Leadership Team in shaping strategy, structure and culture.
• This position makes major decisions for key areas of responsibility including KOL mapping, influence, and advocacy (branded/promotional programs), supporting non promotional content (publication strategies), advisory boards, Certified Diabetes Educator (CDE) program management, National Programs (speaker bureau strategy and programs, NDEI, PriMed) and Interface programs with the VP’s endorsement.

RELATIONSHIPS:
Reports to the Vice President, Diabetes Marketing. Key internal relationships include senior level positions in medical affairs, CMR, Diabetes Sales, Marketing, Legal, Regulatory, Business Development (pipeline/pre-launch drugs) and International Marketing/Medical. Other key external relationships include national and international key opinion and thought leaders and professional services vendors.

ESSENTIAL FUNCTIONS:

FISCAL:
• Budget responsibility of approximately $30 Million with significant impact on revenue.
• Develops and monitors performance against department’s budgets.
• Ensures budgets remain on track.
• Establishes, oversees implementation, and monitors adherence to administrative policies and procedures.
• Evaluates appropriate use of resources to ensure attainment of unit, department and Company profitability goals.
• Reviews and audits staff expense reports.

PRODUCT INVESTMENT:
• Develops relationships with and receives commitment from relevant departments and NNAS to ensure the successful execution of strategies.
• Maximizes revenue and profitability and understands return on investment (ROI) concepts to ensure program effectiveness.
• Partners with Brand teams to identify key metrics and evaluate ROI/impact of programs; collaborates with brand teams in making course corrections if needed.
• Partners with Marketing Effectiveness Leadership to develop and oversee implementation of key metrics (ROI, impact, etc.). Regularly reviews current program progress to ensure profitability/budget goals are on track. If not meeting metrics, proactively implements corrective measures to increase business impact and overall value.

STRATEGIC LEADERSHIP/PLANNING:
• Actively participates as a member of the Diabetes Marketing Leadership team in shaping strategy, structure, and culture.
• Demonstrates strong leadership role across the organization, by effectively promoting and engaging in close collaboration with key internal stakeholders (e.g. Sales, Medical, Legal, Diabetes Marketing).
• Develops and oversees the implementation of strategic business plans for portfolio market shaping. Viewed as a functional expert in this field by internal and external stakeholders. Ensures COE strategies and tactics are aligned with brands and based on the overall brand/portfolio strategy.
• Develops and presents compelling plans for management endorsement.
• Develops strong relationships with leading key opinion leaders/thought leaders to integrate into market shaping activities.
• Develops strong relationships/partners with the Medical Affairs unit within CMR to ensure KOL/HCP relationships are leveraged and aligned with an overall KOL Relationship Management Strategy.
• Forges strong relationships with International Marketing to maximize portfolio market shaping activities.
• Identifies opportunities to coordinate programs across multiple brands/portfolio to ensure scalability, cost savings and alignment.
• Leads the development and execution of portfolio market shaping plan/strategy for products considering product lifecycle (new indication, formulation changes, etc.).
• Leads the Extended Market Shaping Team as part of the Diabetes Governance Structure, and ensure outputs are fed into other governance bodies (e.g. DOT, EBTS, MedMar).
• Liaises closely with Business Development team to ensure full alignment of market shaping activities for pipeline and pre-registration drugs with marketed brands, and identify areas of synergy.
• Oversee integration of promotional medical education into Novo Nordisk’s business planning process.
• Oversees development of the strategic publication plan (for all brands) in collaboration with Medical, to drive brand key messages maximizing reach and impact.
• Proactively communicates with Brands to ensure message alignment and ‘sign off’ prior to implementation.
• Proactively identifies strategies, activities and future direction for market shaping based on best practices. Makes appropriate recommendations to Senior Management Team.
• Provides leadership oversight in ensuring the effective alignment of market shaping tactics across the brands and customer segments (e.g. Endos, PCPs, KOLs, Payors, Patient Marketing) to impact and influence prescribing behaviors.
• Represents Novo Nordisk at International meetings, where applicable.
• Responsible for effectively managing the portfolio market shaping budget within targets.

PHYSICAL REQUIREMENTS:
Approximately 25-30% overnight travel.
Additional Information DEVELOPMENT OF PEOPLE:
Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Leads, directs, motivates, inspires, develops and coaches direct reports.
Manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree and 15 years’ experience, including 10+ years’ progressive product management/marketing, market shaping or medical education experience within the pharmaceutical industry required. Masters or graduate degree preferred with 10+ years’ experience.
• At least 4 years management experience required.
• Demonstrated collaboration skills in leading cross-functional teams required.
• Excellent presentation/communications skills required.
• Prior team leadership and/or management experience required.
• Proven track record of innovative market shaping accomplishments/high impact results (based on metrics/ROI).
• Solid understanding of the marketplace and competition, preferably within diabetes.
• Strategic Planning, Execution and follow-through skills required.
Department DM - MARKET SHAPING
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%]]>Wed, 01 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SR-DIRECTOR-MARKET-SHAPING-Job-NJ-08540/2577022/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SR-DIRECTOR-MARKET-SHAPING-Job-NJ-08540/2577022/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SR DIRECTOR, MARKET DEVELOPMENT - OBESITY
Job Category Marketing
Job Description PURPOSE:
Responsible and lead for the development of the pre-launch and launch Obesity Market strategy, stakeholder engagement strategy, unbranded and branded market shaping strategy, and related initiatives, in alignment with the relevant Global Obesity project launch track and deliverables. This position makes major decisions for key areas of responsibility including:
1) development and support execution the US Obesity Market Strategy and Strategic Relations action plan, in collaboration and coordination with the Global organization, NNI Government Affairs, Medical Affairs and Operations, Managed Market, HCP and Patients Marketing teams,
2) identify all relevant key US Obesity decision makers, influencers and advocates, including healthcare professionals (prescribers, allied health and others Obesity specialists), payers, policy makers and patients groups and organizations,
3) assess stakeholder needs and develop a Novo Nordisk Inc. engagement strategy that supports the Obesity Market strategy, while influencing/aligning with goals of stakeholders, 4) develop market shaping strategy, determine appropriate timing based on Obesity Market and Brand strategy, and execute appropriate initiatives/tactics, through collaboration with cross-functional teams,
5) facilitate the creation of relevant public forum and public dialog around US Obesity issues that align with Obesity Strategy.

Acts as an expert, leader, and cross-functional strategic point person for strategic and tactical execution within designated functional area. Ensures alignment of all Strategic Relations, Engagements and Communications initiatives with US and Global Obesity Launch strategies.

RELATIONSHIPS:
Reports to the Vice President, Obesity. Participates in the US Obesity EBT and relevant Global working groups. Leads US Obesity Market Strategy & Strategic Relations sub-team and relevant cross-functional working groups. Key internal relationships include senior level positions in Medical Affairs, CMR, Government Affairs, Field Execution, Marketing, including but not only Managed Market and Patient COEs, Legal, Regulatory, Business Development (pipeline/pre-launch drugs), Corporate Communication and Global Marketing and Medical Affairs. Other key external relationships include national and international stakeholders and decision makers, from prescribers, to allied health professionals and other Obesity specialists, patients and patient’s organizations, payers and policy makers and professional services vendors. This position provides input to publication strategies and creation and management of NNI Obesity advisory boards and Think Tanks.

ESSENTIAL FUNCTIONS:

Fiscal:
• Budget responsibility with significant impact on revenue.
• Develops and monitors performance against department’s budgets.
• Ensures budgets remain on track.
• Establishes, oversees implementation, and monitors adherence to administrative policies and procedures.
• Evaluates appropriate use of resources to ensure attainment of unit, department and Company profitability goals.
• Reviews and audits staff expense reports.

Product Investment:
• Develops relationships with and receives commitment from relevant departments and NNAS to ensure the successful execution of strategies.
• Maximizes revenue and profitability and understands return on investment (ROI) concepts to ensure program effectiveness.
• Partners with Brand teams to identify key metrics and evaluate ROI/impact of programs; collaborates with Obesity Launch team counter parts in making course corrections if needed.
• Partners with Marketing Effectiveness Leadership to develop and oversee implementation of key metrics (ROI, impact, etc). Regularly reviews current program progress to ensure profitability/budget goals are on track. If not meeting metrics, proactively implements corrective measures to increase business impact and overall value.

Strategic Leadership/Planning:
• Actively participates as a member of the US Obesity EBT and Global working groups shaping strategy, structure, and culture.
• Demonstrates strong leadership role across the organization, by effectively promoting and engaging in close collaboration with key internal stakeholders (eg. Diabetes Portfolio Strategy, Diabetes Market Shaping, Managed Market, Government Affairs, Field Execution, Medical, Legal, Marketing).
• Develops and oversees the implementation of strategic business plans for Obesity. Create and initiate innovative engagement and market shaping strategies. Viewed as a functional expert in this field by internal and external stakeholders. Ensures COE strategies and tactics are aligned with the Obesity brand strategy.
• Develops and presents compelling plans for management endorsement.
• Develops strong relationships with leading key external stakeholders and thought leaders.
• Develops strong relationships/partners with the Medical Affairs, Managed Market, Government Affairs, Corporate Communications, and CMR to ensure key stakeholder relationships are leveraged and aligned with an overall Engagement & Relationship Strategy.
• Forges strong relationships with Global Marketing to maximize US Obesity strategy, market shaping strategy, and engagement & relationship activities.
• Identifies opportunities to coordinate programs across multiple target audiences to ensure scalability, cost savings and alignment.
• Leads development of the Obesity scientific platform and promotional scientific story, including surveillance and evaluation of Obesity publications in collaboration with Medical.
• Leads the development and execution of Obesity strategy, influencer and decision maker mapping, engagement action plan, and tactics considering product lifecycle (new indication, formulation changes, etc.) and within the legal, regulatory and strategic boundaries with our Diabetes business and Victoza in particular.
• Liaises closely with Business Development team to ensure full alignment of activities related to our Obesity pipeline lifecycle strategy and identify areas of synergy.
• Proactively communicates with Brand Lead and COEs to ensure message alignment and sign off prior to implementation.
• Represents as US Obesity leadership at global meetings, where applicable.
• Responsible for effectively managing the Obesity pre-launch and launch budget within targets.
• Understands and monitors complex and evolving compliance landscape. Ensures strategy and plans align with internal policies and external regulations.

PHYSICAL REQUIREMENTS:
Approximately 30 to 35% overnight travel.
Additional Information DEVELOPMENT OF PEOPLE:
• Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree and 15 years' experience, including 10+ years' progressive product management/marketing, market shaping or medical education experience within the pharmaceutical industry required. Masters or graduate degree preferred with 10+ years' experience.
• At least 4 years management experience required.
• Demonstrated strategic and collaboration skills in leading cross-functional teams required.
• Excellent presentation/communications skills required.
• Prior team leadership and/or management experience required.
• Proven track record of innovative market shaping accomplishments/high impact results (based on metrics/ROI).
• Solid understanding of the marketplace and competition.
• Strategic Planning, Execution and follow-through skills required.
Department DM - OBESITY
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 30 - 40%]]>Tue, 14 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SR-DIRECTOR%2C-MARKET-DEVELOPMENT-OBESITY-Job-NJ-08540/2547543/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SR-DIRECTOR%2C-MARKET-DEVELOPMENT-OBESITY-Job-NJ-08540/2547543/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Manager, Compliance Monitoring
Job Category Compliance
Job Description PURPOSE:
Monitor and audit company and individual adherence to Novo Nordisk (NNI) policies, guidelines, Corporate Integrity Agreement, and other defined federal and state laws and requirements. This role will have responsibilities for: (i) conducting monitoring activities and audits of various company records, (ii) assisting with investigations related to audit findings and allegations of non-compliance with company policy, (iii) designing, developing and executing on a detailed project plan for quarterly and annual monitoring and auditing activities, (iv) presenting findings to the Chief Compliance Officer and senior management, and (iv) preparing regular audit reports and presentations in a form that is consistent with the NNI Compliance reporting and Corporate Integrity Agreement requirements.

RELATIONSHIPS:
This position reports to the Senior Manager, Compliance Monitoring & Auditing. Individual will interact daily with Compliance staff and internal counterparts in other NNI business areas including Sales, Legal, Marketing, and various lines of business. The position will establish and maintain relationships with external consultants, Independent Review Organization, outside counsel, and others who might support NNI Compliance monitoring and auditing activities.

ESSENTIAL FUNCTIONS:
• Design, execute and manage against a Field Force monitoring plan to comply with the NNI Field Force Monitoring Program (FFMP) and Non-Promotional Monitoring Program (NPMP) in alignment with the Company Corporate Integrity Agreement
• Conduct and oversee detailed records review of field sales employees’ records and systems relating to interactions with healthcare professionals and institutions; specifically, perform comprehensive reviews of verbatims, sample distribution records, time and expense reports, inquiries relating to medical information, call notes, communications, and other relevant records and documentation; and use the information found to design and carryout further monitoring or auditing operations in an effort to detect potential or actual violations of company policies, as well as federal and state laws and regulations
• Manage external consultants and internal employees conducting live speaker program audits
• Review and address the results of such audits
• Manage documentation and address results from observations (ride-along's) of field sales representatives conducted to assess whether the messages delivered and materials distributed to Healthcare Professionals are consistent with applicable legal requirements and with NNI policies and procedures
• Conduct and oversee detailed review of documentation associated with consulting arrangements, and medical education grants to ensure compliance with NNI policies and procedures
• Develop and maintain knowledge and understanding of: NNI Diabetes and Biopharmaceutical products, industry regulations and guidelines (e.g. Federal Anti-Kickback Statute, False Claims Act), NNI policies, procedures, guidelines, and Corporate Integrity Agreement
• Establish and implement new systems and processes to monitor activities and further the NNI Compliance department monitoring program
• Prepare annual Corporate Integrity Agreement audit report regarding activities associated with the Field Force Monitoring Program and Non-Promotional Monitoring Program
• Prepare frequent reports and present results to the Chief Compliance Officer, managers in the relevant lines of business, and Senior Management
• Review and follow-up on suspected areas of non-compliance with company policies, procedures, or industry regulations
• Work with NNI Compliance Investigations personnel as appropriate during the investigation and development of corrective actions related to incidents of non-compliance or violation of NNI policies

PHYSICAL REQUIREMENTS:
Approximately 10% overnight travel

DEVELOPMENT OF PEOPLE:
• Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process
• Ensure that IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility
• Manage the application and communication of all NNI policies, procedures, and Novo Nordisk Way

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree is required
• A minimum of 8+ years overall experience with a minimum of 5+ years of pharmaceutical or life sciences experience is required; compliance auditing and/or monitoring experience in the Pharmaceutical or life sciences industry is preferred
• Excellent written and verbal communication skills and organization skills are required
• Experience working with or under a Corporate Integrity Agreement preferred
• Must possess an in-depth knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g. FDA, PhRMA Code, Federal Anti-Kickback, False Claims, etc.)
• Must possess an in-depth knowledge and understanding of pharmaceutical sales, marketing, and/or product related practices
• Strong written and verbal communication skills
• The ability to partner and collaborate effectively with stakeholders
• The ability to think objectively and use sound reasoning principles
• Supervisory experience required
Department North America - Compliance (3b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%]]>Wed, 01 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Manager%2C-Compliance-Monitoring-Job-NJ-08540/2574711/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Manager%2C-Compliance-Monitoring-Job-NJ-08540/2574711/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Sr. Attorney
Job Category Legal
Job Description PURPOSE:
Serve as legal counsel to global healthcare company with a focus on a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code.

RELATIONSHIPS:
Responsible for providing contracting, regulatory and general legal support to the commercial organization. Includes daily interaction with the U.S. based brand team(s), marketing departments, medical affairs and regulatory affairs departments, and interaction with headquarters and other affiliates as required. May interact with government agencies, law firms, trade organizations and other external agencies. Reports to Corporate Counsel.

ESSENTIAL FUNCTIONS:
• Serve as lead counsel for one or more pharmaceutical brand(s), and includes participation in multidisciplinary committee in review of marketing materials
• Draft, review and negotiate commercial contracts, 3rd party vendor agreements, service agreements, consulting agreements and other corporate agreements
• Proactively prevent or minimize legal risk to the company, and help drive legal strategy to align and achieve business strategic goals
• Serve as a business partner in support of key customer group(s) with minimal oversight and guidance from managing attorney
• Keeps informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed

PHYSICAL REQUIREMENTS:
Occasional travel required (0-20%)

DEVELOPMENT OF PEOPLE:
Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A J.D. with 6-8 years relevant industry or law firm experience. In-house experience preferred, but not required
• A State Bar admission required
• Experience within the healthcare/pharmaceutical industry
• Strong problem-solving and decision making skills with demonstrated ability to think creatively and devise solutions to challenging problems
• Exceptional written and verbal communications skills – able to effectively collaborate and communicate with stakeholders throughout the company
• Manage workload effectively, set priorities and deliver results on agreed upon timelines
Department LPQ - LEGAL/GOVT & QUALITY AFFAIRS (1b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Juris Doctorate Required
Percent Travel 10 - 20%]]>Thu, 25 Apr 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Attorney-Job-NJ-08540/2567597/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Attorney-Job-NJ-08540/2567597/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Sr. Research Scientist- Translational Research, Cellular Immunology
Job Category Research & Development
Job Description PURPOSE:
The Cellular Immunology department is engaged in identifying, evaluating, and validating potential protein-based lead candidates and protein-drug targets in the area of autoimmune and inflammatory diseases. The incumbent will provide leadership for NNRC’s pre-clinical translational immunology research activities, developing and executing plans for ex vivo target engagement, occupancy and biomarker assays as well as mechanism of action studies with human patient material. The candidate will bring specific expertise in the underlying pathological processes of autoimmune diseases and will come with a track record of successfully enabling the transition of therapeutic candidates into clinical development through translational research activities. The incumbent will collaborate with external partners as well as across NN departments and research sites.

RELATIONSHIPS:
Reports to the Director, Cellular Immunology at Novo Nordisk Inflammation Research Center (NNRC). Supervise the work of at least one Research Associate

ESSENTIAL FUNCTIONS:

SCIENTIFIC ROLE:
• Work within project teams to develop dose guiding and target engagement biomarker strategies.
• Design, develop, and execute studies with patient samples for mechanism of action and biomarker assessment.
• Provide insights into clinical aspects of disease.
• Use translational research expertise to advise projects on relevant patient populations and therapeutic differentiation strategies
• Recommend research directions and implement technologies for the department’s activities, which include functional cell-based immunological assays and approaches for discovering and validating targets.
• Actively review patents and patent applications in areas of research relevance and identify opportunities.
• Assume responsibility for project design and implementation.
• Communicate regularly with international colleagues within Novo Nordisk.
• Day to day supervision of research personnel in Cellular Immunology.
• Develop and manage relevant research protocols in support of pre-clinical translational research efforts
• Draft scientific reports and prepare presentation slides.
• Implement and supervise laboratory studies in support of autoimmunity and inflammation research.
• Interpret and properly document experimental data.
• Maintain current awareness of scientific literature in core disease areas.
• Provide a safe and functional research environment.
• Provide unified research-driven innovation and continuous improvement within own Department and across Departments.
• Work with Director to define and implement therapy area-focused research strategies consistent with organizational goals.

MEDICAL AND RESEARCH COMMUNITY LIAISON:
• Ensure scientific representation at external scientific meetings and conferences.
• Expand existing external research network.
• In compliance with the research strategy and in collaboration with the project teams, identify and expand external research contacts.
• Publicize internally meeting results and collaborative opportunities.
• Write, review and approve collaborative research manuscripts.

SCIENTIFIC SUPPORT FOR OTHER COMPANY ACTIVITIES:
• Oversee company interactions with the expert community (i.e. Advisory Boards, scientific meetings, etc.).
• Provide development opportunities at other company sites.
• Provide internal education and ongoing scientific support as needed.

PHYSICAL REQUIREMENTS:
• Approximately 20% overnight travel

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A PhD, M.D. / PhD, or equivalent with minimum 7 years relevant industry required.
• Prior research or related experience in autoimmunity and inflammation.
• Excellent written and oral communication skills required.
• Excellent interpersonal and motivational skills.
• Extensive experience in pre-clinical translational research in Autoimmunity/Inflammation with a focus on use of patient samples, development of ex vivo assays.
• Experience in the supervision and training of technical staff highly preferred.
• Flexibility and the ability to work in a fast-paced, team-oriented environment are required.
• Industry experience with protein-based biologics or small molecules
• Proven innovative skills.
• Knowledge of the biopharmaceutical development process.
• Strong cellular immunology training and background.
• Strong experience and background in autoimmune diseases and Inflammation.
Department NNRC - CELLULAR IMMUNOLOGY
Position Location US - Seattle, WA
City Seattle
State/Provinces US - WA
Degree Required Doctorate Degree Required
Percent Travel 10 - 20%]]>Wed, 22 May 2013 07:59:00 GMThttp://www.novonordisk-jobs.com/job/Seattle-Sr_-Research-Scientist-Translational-Research%2C-Cellular-Immunology-Job-WA-98101/2504894/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Seattle-Sr_-Research-Scientist-Translational-Research%2C-Cellular-Immunology-Job-WA-98101/2504894/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Account Executive, Biopharm I - Great Plains
Job Category Field Sales
Job Description Account Executive, Biopharm I – Great Plains

The Account Executive, Biopharm I will manage all aspects of sales/marketing activity with targeted managed care accounts in KS, MO, IL, IN, and KY.
These activities will include but not be limited to formulary consideration for all Novo Nordisk products, as well as, to vertically integrate overall corporate and brand awareness across the managed care customer organizational structure. More specifically, the AE I, Biopharm will work with commercial accounts, specialty pharmacies, specialty distributors, home care companies and state government agencies to obtain appropriate product access and increase product market share for the Biopharm Division products. The Account Executive I, Biopharm will work independently and with cross functional teams to develop and implement plans to assure the accomplishment of the key Biopharm strategic goals. This position will work with stakeholders to develop and implement contracts to gain optimal access and market share for the Biopharm brands. This position will be the lead on the development and cross-functional implementation of key targeted product pull and push through campaigns. The Account Executive I, Biopharm will work directly with and/or through cross functional NNI teams with the commercial sector and state government agencies to develop and implement interventions where the potential and probability of success are greatest to support both immediate and long-term NNI business goals. The Account Executive I, Biopharm will be the lead working with cross-functional teams to address inpatient and outpatient reimbursement issues.

RELATIONSHIPS:
This position reports to the Director - Market Access - Biopharm West. This position interacts routinely with Biopharmaceutical Regional Directors, BioPharmaceuticals Sales Managers, Growth Hormone Therapy Managers, Medical Liaisons and ML Management, NovoSeven & Norditropin Marketing, Business Analytics, Managed Market Sales, Health Economics Internal and Field based personnel, Pricing and Contracting Operations, Trade NNI Legal and occasionally Finance. Externally, the position interacts routinely with Specialty Pharmacy, Specialty distributors and home care company owners, presidents, VPs (clinical, sales, reimbursement) and their departments and commercial plan and state government medical directors. This position will also interact with outside reimbursement services vendors (e.g.: Nordicare vendor) and key hospital stakeholders to address reimbursement issues.

The Biopharm portfolio brings with it a unique set of access issues. Theses products require attention to commercial and government access issues pertaining to pharmacy and medical benefit designs and to specialty pharmacy and specialty distribution business relationships. Impacting these channels are essential for the growth and profitability of the BioPharm brands.

ESSENTIAL FUNCTIONS:

Specialty Channel Account Management
• Negotiate contracts and monitor compliance with Specialty Pharmacies, Specialty Distributors and Home Health Care Companies
• Work directly with specialty pharmacy providers, home health care companies and specialty distributors to implement mutually beneficial business to business initiatives that support NNI strategies and key objectives and improve NNI Biopharm product market share.
• Deliver presentations utilizing clinical and pharmacoeconomic data to owners, presidents, VPs (clinical, sales, reimbursement) and their departments of targeted specialty channel accounts.
• Prepare and implement a focused, comprehensive and prioritized annual business plan based on targets, potential return, and competitive environment in order to optimize accomplishment of BioPharm Divisions and NovoSeven and brand team strategic objectives.

? Commercial /Government Account Formulary Access & Pull through
• Research customer’s business situation and discover needs and objectives.
• Anticipate potential trends, changes to market conditions and areas of opportunity and incorporate into the annual business plan.
• Work with cross functional teams to improve and/or maintain access for Biopharm products and develop and implement mutually beneficial initiatives with targeted commercial entities and state healthcare agencies.
• Deliver clinical and financial based value propositions to Medical and Pharmacy Directors of targeted commercial and state Medicaid accounts.
• Work in cross functional teams involving Managed Market Sales, Biopharm sales, HEOR and MSLs on key accounts
• Lead the development and cross-functional implementation pull through and push through campaigns for Biopharm products. Monitor progress and assure goal attainment.
• Coordinate and integrate full/partial field sales support for managed care programs.
• Manage price increases at the account level for all NNI products in accordance with company terms and conditions.
• Coordinate, implement and follow-through on all account contracts, agreements or NNI promotions and incentives.
• Evaluate potential opportunities across payers and other Novo Nordisk, Inc. products to benefit NovoSeven and Norditropin access and reimbursement.
• Train NNI Biopharm sales force on current Biopharm product’s access to enable them to address customer issues effectively and maximize pull through.

Customer Relations
• Organize and participate in meetings, exhibits, conventions, and advisory groups to create sales/marketing opportunities and to establish sound relations with our customer base.
• Identify, develop strong relationships with advocates to create business opportunities for NNI and any co-marketing partners.
• Work in conjunction with co-marketing partners to help customers understand the working relationship of NNI and co-marketing partners.

? Reimbursement Activities
• Work directly with high priority institutions to resolve issues related to NovoSeven reimbursement. Provide necessary support and implement plans to overcome barriers to NovoSeven coverage and reimbursement. Notify field sales and medical management of any/all initiatives that could directly or indirectly impact field activity.
• Monitor, analyze and report on reimbursement policy changes and other payer trends.
• Improve coverage and/or reimbursement policies for Biopharm brands.
• Develop and maintain a database of critical Biopharm brand information related to reimbursement issues, including payer specific policies and trends, account level activities.
• Research and monitor reimbursement profiles of competitive treatments. Compile reimbursement trends.
• Work with other functions as necessary to contribute to the development of Biopharm strategic and tactical Business Plans.
REPORTING
• Maintain and keep current Account Business Plans and communications with a back-up file.
• Develop and submit proposed meeting agendas to NNI participants and the account at least 1 day in advance for all scheduled customer appointments.
• Submit timely Monthly Reports and expense reports.
• Ensure readiness for bi-annual business plan review meetings.
• Submit timely field time/productivity report.
Additional Information KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• Bachelors Degree required; Advance degree preferred
• Minimum of 6 to 8 years industry experience
• Minimum of 2 years of sales management experience is preferred
• Additional minimum of 2 to 4 years of pharmaceutical sales experience strongly preferred
• Previous track record of success within the managed market segment
• Demonstrated ability to lead and work successfully with cross functional teams.
• Excellent verbal and written presentation skills, clinical and business acumen.

OTHER:
• Works within Novo Nordisk’s established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
• Embraces Novo Nordisk Values in spirit and actions.
• Approximately 60-70% overnight travel

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management’s assignment of essential functions. It does not prescribe or restrict the tasks that may be assigned.
Department BIO - MARKET ACCESS WEST
Position Location US - Field Based - Across US
City Kansas City
State/Provinces US - MO
Degree Required Bachelor's Degree Required
Percent Travel 60 - 70%]]>Thu, 09 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Kansas-City-Account-Executive-Biopharm-I-Great-Plains-Job-MO-64101/2590582/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Kansas-City-Account-Executive-Biopharm-I-Great-Plains-Job-MO-64101/2590582/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SR BRAND MGR - HEMOPHILIA A MARKETING
Job Category Marketing
Job Description Sr Brand Mgr - Hemophilia A Marketing

PURPOSE:
This position is accountable for co-leading the development and implementation of turoctocog alfa pre-launch and launch plans and the achievement of NNI P&L goals for assigned products. Incumbent takes a lead role for assigned products on strategic business teams and interact extensively with the enabling functions in Marketing, as well as team representatives from Global Marketing, Sales, Medical, CO&E, Regulatory & Legal. Incumbents are accountable for the implementation of marketing activities for assigned products both marketed and in development. May supervise others. Primary responsibilities include 1) pre-launch/launch planning and execution for turoctocog alfa and 2) Lead patient and HCP strategy development and tactical execution for turoctocog alfa’s commercial plans.

RELATIONSHIPS:
Reports to the Director, Hemophilia A Marketing. Works closely with other Hemophilia Marketing Directos, Associate Directors and Brand Managers. Other internal relationships include relations with Global Marketing, Sales, CO&E, Medical, Regulatory, and Legal personnel. External relationships include relations with professional services vendors for implementation of tactics.

ESSENTIAL FUNCTIONS:
MARKET ANALYSES: Develop and maintain key contacts with different target audiences to fully understand marketplace dynamics.
MARKET ANALYSES: Provide direction towards market research plans for turoctocog alfa.
MARKET ANALYSES: Provide marketing input to CO&E in order to maximize brand income.
MARKET ANALYSES: Work with CO&E/CE to analyze and define the market and provides accurate sales projections/forecasts for existing products.
PRODUCT PLANNING: Implements pre-marketing strategies, and develops marketing thought-leader relationships and involvement.
PRODUCT PLANNING: Lead the development of annual product plans and programs for turoctocog alfa utilizing input of cross-functional business teams and EBT.
PRODUCT PLANNING: Manage all aspects of the marketing mix including promotion, pricing, distribution, and product developments and/or changes.
PRODUCT PLANNING: Serve as team leader to make sure that the product strategies agreed upon are executed in a timely and efficient manner to meet the sales and profit objectives.
PRODUCT PLANNING: Work closely with field sales to ensure marketing programs are developed that strongly support their direct and indirect needs with customers.
PRODUCT TEAM LEADERSHIP: Develop and manage an Extended Brand Team to ensure inclusion of relevant functions’ input into brand marketing strategies and tactics.
PRODUCT TEAM LEADERSHIP: Serve as expert marketing counsel for Product and Associate Product Managers on the brand team.
PRODUCT TEAM LEADERSHIP: Supervise, coach, evaluate, and counsel other members of the team as required.
PROMOTIONS: Develop and disseminate promotion and training programs, including coordination of involved external suppliers and agencies, and with input from sales.
PROMOTIONS: Develop and implement marketing plan with promotional budget responsibility. Implement promotional tactics within budget parameters.
PROMOTIONS: Manage the advertising agency and promotional review system to implement overall campaign elements, educational, promotional and public relations programs.
PROMOTIONS: Select and manage professional services to create effective launch programs to maximize return on investment. This includes symposia, speaker’s programs, print and digital marketing materials.

PHYSICAL REQUIREMENTS:
Approximately 30% overnight travel

DEVELOPMENT OF PEOPLE:
Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A Bachelor’s degree required.
At least six or more years in sales and product management/marketing experience within the pharmaceutical industry required
Launch and hemophilia experience preferred
Outstanding planning and organizational skills with exceptionally high attention to quality of detail and proven track record of results and follow up
Solid understanding of the pharmaceutical marketplace including medical, regulatory and clinical processes
Department BIO - HEMOPHILIA MARKETING (3)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%]]>Thu, 09 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SR-BRAND-MGR-HEMOPHILIA-A-MARKETING-Job-NJ-08540/2590580/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SR-BRAND-MGR-HEMOPHILIA-A-MARKETING-Job-NJ-08540/2590580/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title BRAND MANAGER - VICTOZA
Job Category Marketing
Job Description PURPOSE:

Accountable to assist in the development and implementation of the overall strategy, key strategic imperatives, positioning and messaging for assigned products in order to ensure the achievement of Novo Nordisk P&L goals. Responsible to assist in the development, execution and implementation of annual brand tactical plan while ensuring brand/portfolio alignment with customer segments. Participates in cross-functional EBTs for designated brand and interacts extensively with the other functions within Novo Nordisk. Accountable for the implementation of marketing activities for Victoza® while refining messaging to specific customer segment and ensuring brand alignment of all initiatives within Diabetes Marketing. Develops key messages and positioning for that brand and proactively communicates with Portfolio Leads and others to ensure transparent communications within and outside the department.

RELATIONSHIPS:
Reports to the Brand Director Victoza. Works closely with other Brand Managers and other units within Diabetes Marketing. Other internal relationships include relationships with Sales Training, Medical, Managed Markets, Regulatory, Sales and Legal personnel, and international colleagues. External relationships include relations with professional services vendors.

ESSENTIAL FUNCTIONS:

Brand Planning:
• Assists in developing and coordinating overall brand plan, ensuring alignment of brand positioning and messaging
• Develop and present compelling plans for management endorsement.
• Develops and executes marketing plans through the extended brand team.
• Develops personal and non-personal HCP promotional materials – collaborate with COE for respective expertise in customer segment
• Execute the effective integration of various marketing tactics – medical education, advertising, public relations, sales force, patient education, etc.
• Work closely with all cross – functional areas (for example; medical, field sales, regulatory) to ensure successful development and execution of marketing plans.
• Work effectively with international colleagues.

Brand Team Leadership (May Be Applicable):
• Champions the Triple Bottom Line in brand development, strategy and tactical initiatives.
• Clarifies vision, mission and long-term goals for the cross-functional members.
• Coordinates a cross-functional team of interdepartmental members for brand activities and assures strategic alignment.
• Understands Novo Nordisk’s values and their importance to business results.

Market Analyses:
• Analyze and define the market and provide accurate sales projections/forecasts for existing products.
• Develop and maintain key contacts with different target audiences to fully understand marketplace dynamics.
• Develop marketing input to extended brand teams in order to maximize brand income.
• Provide guidance to market research plans for assigned products.

Promotions:
• Assist in leading key non-Patient Marketing/HCP RM initiatives as needed by brand team.
• Assist in other brand functions as needed including special projects and process improvement initiatives.
• Develop and disseminate promotion and training programs, including coordination of involved external suppliers and agencies, and with input from sales.
• Develop and implement marketing plan with promotional budget responsibility. Implement promotional tactics within budget parameters.
• Liaison to other NNI functions as needed to support brand initiatives.
• Manage the advertising agency and promotional review system to implement overall campaign elements, educational, promotional and public relations programs.
• Select and manage professional services to create effective launch programs to maximize return on investment. This includes symposia, speaker’s programs, print materials, and Phase IV studies.

PHYSICAL REQUIREMENTS:
Approximately 30% overnight travel.

DEVELOPMENT OF PEOPLE:
Not Applicable.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree or equivalent experience, MBA preferred
• At least three (3) to five (5) years sales and/or Brand management/marketing experience within the pharmaceutical industry required.
• Planning, Execution and Follow-Up – effectively prioritizes and spends his/her time and the time of other on what is important. Develops accurate short and long term plans. Ensures timely execution and follow-up. Meets deadlines. Anticipates problems and roadblocks to avoid crisis management.
• The ability to work on cross functional teams.
Department DM - VICTOZA (3)
Position Location US - Princeton, NJ
City Princenton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 20 - 30%]]>Mon, 20 May 2013 05:00:00 GMThttp://www.novonordisk-jobs.com/job/Princenton-BRAND-MANAGER-VICTOZA-Job-NJ-07101/2607381/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princenton-BRAND-MANAGER-VICTOZA-Job-NJ-07101/2607381/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title DEM - CAROLINAS
Job Category Marketing
Job Description PURPOSE:

Position provides management, coaching, mentorship and direction & guidance to a team of Diabetes Educators. Responsible for the administrative and management support of field-based DE Program at Novo Nordisk Inc (NNI). Accountable to ensure proper execution of training program by DE’s.

RELATIONSHIPS:

Position reports to the Associate Director, Diabetes Education Program. Has direct field management responsibility for field-based Diabetes Educators (DEs). Additional key relationships are with Marketing, Sales & Medical. External relationships include physicians, nurse practitioners, DE’s, patients & healthcare providers.

ESSENTIAL FUNCTIONS:

MANAGEMENT

• Coach and develop DEs and ensure that overall team objectives are being met.
• Mentor and build the talents of DE team members particularly with respect to knowledge of technical and product information, business practices and communication skills.
• Ensure that DE personnel understand ADA training standards, that their work is focused on those priorities, and that they understand their level of accountability for results and the measurement process.
• Coordinate with other DE managers to ensure consistency of training and development approach across different areas while customizing initiatives to best fit the unique needs of direct reports.
• Responsible for ensuring and tracking compliance with regulatory/legal mandates.

PLANNING AND FIELD-BASED SUPPORT

• Provide leadership for ongoing training support for DEs in the areas of responsibility as needed.
• Collaborate with Associate Director DEP to implement strategies of the NNI Diabetes Education Program.
• Works with the Associate Director, to identify educational needs, research opportunities and implements tactics to support training needs in each area of responsibility.

COORDINATION OF EDUCATIONAL PROGRAMS

• Assist Associate Director with planning and DEivering presentations for POA meetings.
• Coordinate the development of education seminars for health care providers on subjects relevant to NNI’s products.
• Provide overall support of DE educational needs.

ADMINISTRATIVE DUTIES:

• Accountable for the continuous management and oversight of DE and AHP budget to target levels
• Evaluates appropriate use and allocation of resources to ensure attainment of unit, department and Company profitability goals.
• Responsible for effectively managing budget within targets.
• Establishes, oversees implementation, and monitors adherence to administrative policies and procedures.
• Ensures budgets remain on track.
• Analyze, review and provide monthly report on DE activities for direct reports in regions to Associate Director.
• Secure effective administrative management of regional business as well as operational and educational budgets.
• Review and audit direct reports’ expense reports. Exercise prudent control of field expenses.

DEVELOPMENT OF PEOPLE:

• Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
• Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

KEY SUCCESS FACTORS:

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• Bachelors degree required.
• 5 - 7 years experience in a health-related system or pharmaceutical company.
• One to two years of experience as a DE or equivalent positions required.
• Extensive experience in diabetes preferred.
• Prior management and/or team leadership experience preferred.

OTHER:

• Works within Novo Nordisk’s established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
• Embraces Novo Nordisk Values in spirit and actions.
• Approximately 50% overnight travel.
Additional Information to be opened as DEM- Carolinas
job code: S064A
Department DM - CAROLINAS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 50 - 60%]]>Thu, 09 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-DEM-CAROLINAS-Job-NJ-08540/2590577/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-DEM-CAROLINAS-Job-NJ-08540/2590577/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Senior In-House CRA
Job Category Clinical
Job Description PURPOSE:
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical, Medical & Regulatory Affairs (CMR). Responsible for monitoring assigned sites in accordance with GCP/ICH and Novo Nordisk (NNI) SOPs.

RELATIONSHIPS:
Reports to a Manager/Senior Manager of Site Management (SM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.

ESSENTIAL FUNCTIONS:

COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.

FUNCTIONAL SUPPORT:
May participate in continuous improvement processes for function.

PROJECT SUPPORT:
- Accountable for the set up, quality and maintenance of the electronic Trial Master Files (TMF) in accordance with NNI SOPs. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines.
- Accountable to provide develop regulatory documentation to support study start up activities, including all site supplies.
- Act as primary liaison for assigned study sites to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues.
- Act as primary liaison for assigned study sites while on-site to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA to resolve site related issues.
- Arranges for certified translation of study documentation as appropriate.
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation. Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA.
- Attends Investigator Meetings and study-specific training for assigned trials
- Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate.
- Collaborates with the Lead CRA(s) to obtain/share trial specifics issues across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and/or CRAs as appropriate.
- Completes follow up letters from all visit types according to SOPs and complete reports to quality standards within company specified timelines.
- Completes Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs and completes reports to quality standards within company specified timelines.
- Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.
- Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned CRA.
- Liaises with Clinical Budget Management to secure confidentiality agreements, master services agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight approval.
- Monitors recruitment and data quality while on site and remotely through EDC systems/communication with sites.
- Performs on-site drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements.
- Preparation and review of various study related tracking systems to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB etc) and responsible for the follow up to collect outstanding documents.
- Provides quality overview and consistency check on all developed ICFs and completes the informed consent checklist.
- Responsible for maintaining current Investigator Trial File (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines while on site.
- Responsible for the submission and correction of regulatory green light packages to the Quality Management Group within CTM for approval.
- Responsible to coordinate and secure IRB approval (local and central). Responsible to provide step by step guidance and partnership with sites to secure IRB approval.
- Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.

STAFF DEVELOPMENT:
- May provide active mentorship of CTM staff to build talent across the department.

TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams.
- Participates in cross-functional teams, locally, to assure timely attainment of project milestones.
- Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to ensure that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.

TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.

PHYSICAL REQUIREMENTS:
- Approximately 50% overnight travel to visit assigned sites for monitoring and/or trainings as required
- Office Based in Princeton, NJ.

DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department.
- May support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- A Bachelors’ degree (in life science discipline) or BSN; Advanced degree preferred.
- A minimum of 6 years of clinical trial experience within pharmaceutical and/or healthcare setting,
- Direct expertise of site management and logistical execution of clinical trials for 3 years.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
- Previous on site monitoring experience required.
Department CMR - SITE MANAGEMENT (1a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 40 - 50%]]>Sat, 04 May 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Senior-In-House-CRA-Job-NJ-08540/2531552/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Senior-In-House-CRA-Job-NJ-08540/2531552/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Health Systems District Business Manager (HSDBM) - Northern California
Job Category Field Sales
Job Description Health Systems District Business Manager (HSDBM) - Northern California

PURPOSE:
To develop and lead health system sales teams in the execution of sales strategies within targeted Integrated
Delivery Network (IDN) accounts. Manages, trains, and develops direct reports, while managing district budgets and executing district IDN business plans.
RELATIONSHIPS:
Reports to the HS Regional Business Director. Has direct supervisory responsibility for Health System
Diabetes Care Specialists (HSDCS). Works closely with Health System Manager, other Health System
District Business Managers, Endocrinology District Business Managers, District Business Managers, Regional
Business Director, Managed Market Sales, Trade, Medical, and home office personnel to achieve sales objectives and to ensure the development of their teams. Other relationships include key headquarter stakeholders, health care professionals, key accounts, co-promotion partners, and associations.
ESSENTIAL FUNCTIONS:
Administration: Continuously improve the knowledge of Novo Nordisk products, competitive products, and
management skills through ongoing home study and participation in company sponsored/approved training
programs.

Business Planning: Execute IDN level account targeting strategy to fulfill regional account targeting strategy requirements.
Manage district and regional resource allocation.
Manage IDN customer needs assessment. Apply assessment frameworks against accounts in district by overseeing HDCS account assessment activities. Identify program/service requirements for addressing needs. Work with the VP Diabetes Sales, Regional Business Directors and appropriate home office management to feed requirements into program development (contracting, marketing programs).
Manage the execution of the regional business plan to achieve the fulfillment of Plan
objectives/requirements. This includes delivery-of-care system delineation, account targeting, needs assessment, and program implementation.
Monitor district program/initiative effectiveness.
Monitor performance against strategic account management objectives/directives.
Oversee IDN account relationship development/management. Manage critical regional
account relationships and set account relationship development objectives for regional staff.

Compliance: Adhere to the Prescription Drug Marketing Act of 1987 and all related Novo Nordisk policies
regarding the judicious use of physician samples and stock items.
Ensure timely and accurate transmission of metrics
Monitor and reinforce the use of the Advantedge System.

Execution of Goals and Objectives: Ensure appropriate level of coordination to attain regional business plan objectives.
Ensure contractual requirements are met for the region
Ensure cooperation and congruence of programs and initiatives with HSM, other Health System Institutional District Business Managers, Endocrinology District Business Managers, District Business Managers and home office.
Oversee regional level coordination between field resources, intraorganization
resources and inter-organizational resources.

Facilitates Collaboration: Collaborates closely with HSM, HSDBMs IDBMs, EDBMs and DBM’s to ensure organizational alignment and synergy
Communicate Regional activity of competitive products through timely communication as directed
Develop and monitor performance against regional and district budgets.
Ensure timely and accurate submission of administrative requirements.
Establish and oversee regional implementation, and monitor adherence to administrative policies and procedures.
Evaluate appropriate use of regional resources to ensure attainment of sales goals.
Review and audit expense reports.

PHYSICAL REQUIREMENTS:
Must maintain a valid driver’s license and obey all applicable traffic laws.

DEVELOPMENT OF PEOPLE:
Ensure that reporting personnel have ACE forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those
priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way
of Management.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A Bachelors Degree required from college or university accredited by an organization recognized by the U.S.
Department of Education - major in Business or Marketing preferred.
Minimum of 6 years of progressive pharmaceutical/healthcare sales experience required with a minimum of 2 years district management experience required.
Department SALES - NORTHERN CALIFORNIA (HS)
Position Location US - Field Based - Across US
City San Francisco
State/Provinces US - CA
Degree Required Bachelor's Degree Required
Percent Travel 30 - 40%]]>Thu, 09 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/San-Francisco-Health-Systems-District-Business-Manager-%28HSDBM%29-Northern-California-Job-CA-94101/2590579/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/San-Francisco-Health-Systems-District-Business-Manager-%28HSDBM%29-Northern-California-Job-CA-94101/2590579/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Manager, Training - Clinical Trial Management, Quality Management
Job Category Clinical
Job Description PURPOSE:
To ensure compliance with Federal regulations and company SOPs to ensure Clinical Trial Management (CTM) technical training is comprehensive, up dated and relevant for the department. To ensure accurate, timely and current updates to training materials and resources in use by the CTM team related to current and future trials and FDA guidelines. Create, review, update and archive CTM technical training materials and new hire materials. To serve as resource to the overall CTM team in relation to training requirements locally & globally and ensuring the maintenance & compliance with ISOTrain records, curriculums, training records and associated documentation across CTM. Projects will be allocated across team members to optimize workflow and according to business priorities.

RELATIONSHIPS:
Reports to Head of Quality Management, Clinical Trial Management. Additional key internal relationships include functional head across CTM, all mangers within CTM, Novo Nordisk Talent Management and other technical training support across Clinical Medical and Regulatory (CMR).

ESSENTIAL FUNCTIONS:

FUNCTIONAL SUPPORT:
• Act as a technical training resource for the CTM team.
• Act as point person to represent the CTM team to liaise with key internal stakeholders cross-functionally on appropriate projects
• Assist in preparation and implementation of CTM training initiatives. This includes new hire scientific training, on-going protocol training (Tele/Web-conferences or live training at forums/CTM meetings) and other initiatives to ensure CTM team members have the most current information and “best in class” clinical support in relation to technical training.
• Maintain knowledge database for the CTM team.
• Submit all training materials/slides and other resources for appropriate review (quality, legal, Novo Nordisk Communications) to assure compliance with standardized review processes of materials used by professionals in the CTM team.
• May be responsible to identification training gaps within CTM and will support the development of training materials to meet that gap and then provision of training as required to improve technical skill set of the department.
• Apply adult learning and instructional design principles when developing training programs and materials.
• Accountable to ensure ISOTrain curriculum are current for all staff across CTM.
• Responsible for the development and maintenance of training records and associated documentation for departmental records and audits.

STAFF DEVELOPMENT:
• Active mentorship of CTM staff to build talent across the department.
• Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of self and instil in all staff across CTM department.
• Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
• Ensure CTM staff understands the principles of assuring patient safety, data integrity and regulatory compliance.
• Ensure the consistent implementation of GCPs, SOPs and protocol specific procedures across CTM, through the development and provision of technical training.
• May assist in identifying individual core technical learning needs of CTM staff.
• May contribute to input and maintain guidelines, policies and procedures for the function locally.
• May provide input, support and communicate functional, departmental or organizational initiatives.

TEAM COORDINATION:
• Accountable for the compliance and quality of CATS reporting as required per departmental expectations.
• Cross team membership, coordination and motivation of the region across NNI.
• Implements and may participate in continuous improvement processes for function.
• Implements cross departmental work, locally, and communications for assigned as per the clinical development plans.
• Implements work within cross-functional teams, locally, to assure timely attainment of department milestones within CRM
• Initiates discussions with respective key project stakeholders for clarification and guidance on directives received from others.
• May be a member of the local CTM SOP Group.
• Responsible for maintaining focus, locally, for specific department activities within CMR priorities.
• Attend relevant symposia, conferences and scientific meetings, as necessary.

PHYSICAL REQUIREMENTS:
• Office based – Princeton, NJ
• Less than 10% travel

DEVELOPMENT OF PEOPLE:
• Active mentorship of CTM staff to build talent across the department.
• As a CTM Member responsible for staff development to ensure staff are actively developed in the accordance with the departmental expectations.
• Be primary examples of the Novo Nordisk Way.
• May identify technical training gaps within the department, will support the development of training materials to meet that gap and then provision of training as required to improve core skill set of the department.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor of Science or a Bachelor of Arts in a scientific discipline.
• At least a minimum of 8 years of clinical trial experience within industry or healthcare setting required with proven experience in clinical trial related training.
• Advanced knowledge of Good Clinical Practice (GCPs), ICH Guidelines, federal and local regulations, research process and scientific knowledge as relates to clinical trial conduct.
• Proven a demonstrated competency in coaching and training of clinical research staff.
• Strong communication (written and verbal), customer focus, analytical, negotiation, meeting and time management, cross-functional team, understanding of a metrics driven organization and strong leadership skills required. Must have the ability to function independently with minimal supervision.
• Demonstrated computer skills (MSOffice, Excel, PowerPoint).
• Previous proven development or line management of industry based clinical trial staff preferred.
Department CMR - QUALITY MANAGEMENT
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%]]>Fri, 26 Apr 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Manager%2C-Training-Clinical-Trial-Management%2C-Quality-Management-Job-NJ-08540/2518474/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Manager%2C-Training-Clinical-Trial-Management%2C-Quality-Management-Job-NJ-08540/2518474/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SR BRAND MANAGER - OBESITY
Job Category Marketing
Job Description PURPOSE:
• Develops the commercialization strategy for Obesity for Health Care Providers (including physicians, registered dietitians and certified diabetes educators) and payers. Develops personal and non-personal HCP promotional materials; ensures alignment of brand positioning, messaging and overall objectives. May refine messaging based on specific customer segments. Identifies and implements improvements to prepare for launch, development and/or life cycle activities.
• Responsible for collaboration with Patient Marketing colleague to ensure consistency of messaging.

RELATIONSHIPS:
Reports to the Brand Director – Obesity. Interacts closely with the NN A/S Global Marketing supporting Obesity and Marketing within NNI. Also interacts with all NNI Brand Marketing functions, as well as with team representatives from Medical, Managed Markets, Corporate Communications and Public Affairs, Regulatory, Sales, and Legal.

ESSENTIAL FUNCTIONS:

Brand Planning:
• Develops and presents compelling plans for management and cross-functional endorsement within NNI (for example, medical, regulatory, marketing and sales)
• Responsible for effectively managing budgets.
• Works effectively with Global marketing on the development of the HCP, payer and market shaping strategy.

Essential Functions:
• Develops and implements marketing plan.
• Develops and oversees the implementation of pre-launch and launch plans, and post launch business plans/strategies. This includes in-depth market analysis, market research activities, thought leader development, HCP and patient marketing, medical education, sample planning forecasting, pricing strategy, etc. within specific assignment.
• Develops relationships with and receives commitment from relevant NNI and NNAS departments to ensure the successful execution of strategies.
• Develops, manages and disseminates the implementation of promotional programs, including coordination with Sales Training and with external suppliers and agencies.
• Implements pre-marketing strategies and develops marketing thought-leader relationships and involvement.
• Maximizes revenue and profitability and understands return on investment (ROI) concepts to ensure program effectiveness.
• Proactively communicates and collaborates with Centers of Excellence (COEs) and others to ensure transparent communications and alignment of strategies and tactics within and outside the department.
• Responsible for providing interface with key stakeholders. Represents the organization as prime internal and external contact on projects, contracts or operational decisions.
• Understand competitive set and address obstacles for the brand through the course of the year to ensure brand success.
• Understands the definition of the market and develops accurate sales projections/forecasts for designated product.
• Works closely with field sales to ensure marketing programs that are developed strongly support their direct and indirect needs with customers and drive appropriate ROI.
• Works effectively with international colleagues to define: new product launches, campaign development, competitive defense and strategic evolution of the product.
• Works effectively with key support functions to ensure alignment with the brand objectives and goals.

Market Analysis:
• Analyzes and defines the weight loss management market and coordinates accurate utilization projections/forecasts for Obesity.
• Collaborates with other departments and areas in gathering input to in order to maximize integration across diabetes brands.
• Develops and maintains key contacts with different target audiences to fully understand marketplace dynamics.
• Provides guidance to market research plans for the development of the Obesity commercialization strategy.

Marketing Tactics:
• Assists in the development of the market shaping strategy for Obesity.
• Drive the development of the commercialization strategy for Obesity for Health Care Providers and payers. Responsible for development of customer segmentation and product positioning for Lira Obesity.
• Works closely with Global Marketing and the Agency of Record on the market shaping tactics to ensure strategic alignment of the execution.

Promotions:
• Develop and disseminate promotion and training programs, including coordination of involved external suppliers and agencies, and with input from sales.
• Develop and implement marketing plan with promotional budget responsibility. Implement promotional tactics within budget parameters.
• Manage the advertising agency and promotional review system to implement overall campaign elements, educational, promotional and public relations programs.
• Select and manage professional services to create effective launch programs to maximize return on investment.

PHYSICAL REQUIREMENTS:
Approximately 25% overnight travel.

DEVELOPMENT OF PEOPLE:
Not Applicable.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• 7 years sales and/or marketing and/or product management/marketing experience within the pharmaceutical industry (preferably with a focus on physicians and allied healthcare professionals).
• A Bachelor’s degree in business or related field required; an advanced degree or equivalent experience preferred.
• An MBA is preferred.
• Demonstrated experience with developing marketing strategies and promotional tactics required.
• Experience managing external vendor relationships.
• Previous experience in leading high performing cross functional teams.
• Prior new product commercialization or launch experience preferred.
• Proven track record in new product marketing preferred.
• Solid understanding of the pharmaceutical marketplace including medical, regulatory and clinical processes, preferably within obesity and/or diabetes (specifically injectable products).
• Successful launch experience in a marketing role.
• Understanding of the prescription obesity market preferred.
Department DM - OBESITY (2)
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%]]>Mon, 13 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SR-BRAND-MANAGER-OBESITY-Job-NJ-08540/2546013/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SR-BRAND-MANAGER-OBESITY-Job-NJ-08540/2546013/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS