http://www.novonordisk-jobs.com/feeds/Clinical-Research-Associate-nj-jobs/ Custom RSS Feed for Clinical-Research-Associate-nj-jobs Sun, 19 May 2013 11:35:25 GMT en-us /sites/novonordisk/images/Novo_Banner.gif http://www.novonordisk-jobs.com/feeds/Clinical-Research-Associate-nj-jobs/ 720 Title Senior Project Manager - Clinical Strategy
Job Category Medical
Job Description PURPOSE:
This is a project management role which streamlines communication and fosters ongoing collaboration between CTM, MA, and CDR to enhance the researcher and patient experiences through the Medical Associates Research Collaboration (MARC). Ultimately, this role will support efficiencies for the role of medical affairs in the Novo Nordisk clinical trials. In addition, the Senior Project Manager, Clinical Strategy will be responsible for the financial management of the overall US Medical Affairs budget including tracking and reporting.

RELATIONSHIPS:
This position reports directly to the Director, Medical Affairs – Clinical Strategy and has broad responsibility for managing multiple internal relationships within and across Novo Nordisk Inc. as well as with Global HQ. This position will liaise primarily with internal Medical Affairs, Field Medical Affairs personnel, Clinical Trial Management, Clinical Development, Global Medical and other functions. Additionally, this role will work in close collaboration with and utilize inputs from cost center Managers and key stakeholders involved in the budget and planning process, as well as partner with the US Finance group.

ESSENTIAL FUNCTIONS:
MARC ACTIVITIES:
• Central point of communication for internal support of Novo Nordisk sponsored trials. Partner and liaise with clinical trial management, field medical affairs, medical affairs, clinical development and research, and the global team to provide project support in various stages of trial lifecycles
• Develop and Maintain tracking reports for:
a. requests for study support
b. FMA involvement in study support, including all site assignment lists, key milestones and metrics
c. key major events across the development program
d. demonstrating the value of the collaboration
• Develop tools and training for MARC facilitators and field teams as necessary
• Coordination of and frequency of facilitator meetings/teleconferences and training
• Develop solutions to support MARC field teams
• Ongoing support of the MARC web portal
• Maintenance of MARC facilitator team mapping/roster/size/geographic coverage

BUDGET & CONTRACT COORDINATION:
• Ensure Medical Affairs budget is developed and managed in line with organizational expectation, including the development of appropriate project budgets
• Works with cost centers to facilitate the accrual process and meets with designated cost center/project owners to prepare month-end accruals journal entries.
• Analyzes financial data and monitors the execution of expenditures against the operating plan, partnering with cost center/project owners to make adjustments when necessary and ensure amounts and timing are current and accurate
• Validates projects against Statements of Work (SOW), contracts, and supporting documents to ensure funding levels, due dates, contract compliance and authorizations
• Ensures the validity of the data (planned, actual) within the financial systems (SAP and BW) and confirms project estimates are updated
• Prepares Project Summary reports and other ad hoc reports of Projects Planned, including Actual vs. Budget spend.
• Prepares BW/SAP queries, the Rolling Estimate (RE) and Anchor Budget (AB) process as required.
• Evaluates budget input and phasing for the reallocation of funds
• Coordinates the financial project planning process through direct interaction with supported project owners
• Assist department in meeting the balanced scorecard requirements by continuously monitoring the budget status.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree required; Degree in Accounting, Finance, or related field preferred. A minimum of 5 years financial analysis/reporting and accounting experience required. MBA and Pharmaceutical experience or experience in the healthcare or clinical trial environment is preferred.
• A minimum of 9 years in a project management role including Budgeting, Resource allocation/optimization experience.
• A minimum of 7 years’ experience understanding systems and requirements to set and measure cross-departmental functional deployment to meet corporate goals
• 5 years of clinical trial experience within pharmaceutical and/or healthcare setting is preferred.
• Knowledgeable of drug development and GCP principles as it relates to clinical trial management
• Analytical, negotiation, meeting management, cross-functional team and leadership skills required
• Project management and reporting experience with the ability to interact with various departments and levels internally.
• MS Office skills required with an advanced understanding of Excel. Knowledge of SAP ECC and BW preferred.
• Solid communications and relationship building capacity. Strong attention to detail and commitment to quality.

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 15% overnight travel
Department CMR - FMA CLINICAL STRATEGY
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%]]>Wed, 01 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Senior-Project-Manager-Clinical-Strategy-Job-NJ-08540/2574713/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Senior-Project-Manager-Clinical-Strategy-Job-NJ-08540/2574713/?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 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 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 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 Director of New Product Commercialization & Business Development
Job Category Marketing
Job Description PURPOSE:
Leads the identification, development and implementation of breakthrough business development opportunities related to specific assigned areas that will further enable Novo Nordisk to become the US leader in Biopharmaceuticals. Ensure all internal and external opportunities provide sustainable value and high impact to Novo Nordisk. Work closely with the Brand Leadership (US and international marketing) teams to ensure alignment and that collaborative actions are taken to achieve our short and long term profitability goals. Work closely with headquarters business development group to support global business development efforts. Business development projects may include (but not limited to) in- and out-license, acquisitions, cross- and co-promotion alliances, co-development, etc.

RELATIONSHIPS:
Reports to CVP, BioPharmaceuticals. Externally will develop and manage interactions with senior business development and executive positions with potential partners. Internally, interacts with Executive Team members and key Legal, Sales and Marketing functions. Will also interact with Finance, Regulatory, Medical, Strategic Business Development. Manages a team of pipeline strategy associate directors and managers.

ESSENTIAL FUNCTIONS:
• Collaborate with corporate business HQ colleagues and provide US leadership and input on projects that are managed at a global level. Ensure strategy is in alignment with US business. Lead projects to completion including contract negotiation when assigned for US implementation.
• Collaborate with HQ to develop a ‘best in class” business development capability at Novo Nordisk.
• Develop, execute and track project plans against success criteria for key initiatives (including stakeholder buy-in).
• Ensure ongoing monitoring of all business development activities to ensure agreements are meeting established success criteria.
• Identify target products and technologies, initiate contacts, develop the full business case and assess opportunities (full financial, legal, intellectual property and commercial analysis) to advance projects for approval by US executive management and/or corporate business development.
• Lead and/or direct new product commercialization processes for all new product commercialization products across BioPharm to ensure commercial input into clinical development regarding target product profile, labeling, and trial design input.
• Lead the implementation of the US Business Development Plan – initiate contacts, assess opportunities (lead full financial, legal, intellectual property analysis) to bring specific projects to a point where they can be approved by US executive management or brought to headquarters Business Development for consideration.
• Maintain a strong network of industry contacts; continually seek competitive intelligence. Actively participate in relevant industry meetings and conferences.
• Make recommendations regarding the business case to Executive Team (ET), HQ or other management teams based on best interest for the business.
• Provide US-based business development leadership to global BD projects including acquisitions, in-licensing, co-promotions, etc.
• With Key Stakeholders, develop and/or update a comprehensive business development business plan for the BioPharmaceuticals businesses as assigned that identifies and assesses high priority initiatives which are aligned with short-term and long-term brand, portfolio and corporate strategies. Ensure input and buy-in from key internal stakeholders.

PHYSICAL REQUIREMENTS:
Approximately 25-35% 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 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
• 10 years of relevant pharmaceutical sales, marketing and progressive new product commercialization strategy and/or business development experience in the US. Ideal breadth of experience includes acquisition, in- and out-licensing, co promotions, etc.
• A Bachelor’s Degree or equivalent experience. Master’s Degree preferred.
• Executive presence – ability to impact and influence and interact with senior business leaders and partners.
• Experienced in deal making (including strong negotiation skills). Has played a role leading and supporting in-licensing, out-licensing, collaboration and co-promotion deals, and/or acquisitions. Has experience identifying, conducting due diligence, negotiating and completing transactions. Collaborates effectively with Legal, Regulatory and Finance.
• Knowledgeable of the Biopharmaceutical industry and specific expertise in multiple therapeutic areas. Knows the science, clinical practices, market dynamics, competitive products, competitive selling strategies, etc., in domestic and international markets.
• Networked broadly within the industry and has an Entrepreneurial mindset.
• Possessing a good understanding of drug development and commercialization. Has experience working collaboratively, cross-functionally and globally with Research & Development, Medical Affairs, Commercial Development and Marketing to formulate portfolio strategy and drive competitive initiatives.
• Strong understanding of broad commercial strategies, financials, IP and legal issues involved in business development projects preferred.
Department BIO - BUS DEV / NEW PRODUCT COMML'ZN
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 20 - 30%]]>Sat, 18 May 2013 05:31:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-DIR-BD-&-NPC-Job-NJ-08540/2357081/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-DIR-BD-&-NPC-Job-NJ-08540/2357081/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Director, CMR Training & Development
Job Category Human Resources
Job Description PURPOSE:
The Director, CMR Training & Development is responsible for leading the design, development, creation, and effective execution of multiple types of high quality learning solutions and associated metrics that meet current and future business needs of the Clinical Development, Medical & Regulatory Affairs (CMR) organization and result in enhanced capabilities and performance of CMR associates. They will lead the creation of an enterprise-wide strategy and approach that accelerates leadership & professional development consistently across all CMR functions in support of Novo Nordisk Inc. (NNI) strategy and goals. Serves as a primary leader in driving the core learning strategy and provides valuable support and consultation to both Senior Leaders in the Line of Business and Heads of HR for CMR. The Director will demonstrate exceptional ability to proactively partner with and appropriately influence key leaders and HR Business Partners.

RELATIONSHIPS:
Reports to the Sr. Director, Executive & Professional Training & Development. Interacts with CMR Leaders, other business units and functional academies to identify, design, deliver and communicate learning & development resources, strategies and initiatives to maximize CMR capabilities and bench strength. Manages a team of CMR training staff and matrixes with line of business training resources. Closely partners with line leaders, HR Business Partners and colleagues within Talent Management in understanding, designing and executing key training initiatives/programs. Co-leads with Sr. Director, HR a CMR Training steering committee to ensure alignment and execution of short and long-term learning and development strategy. External relationships include working with various vendors to supplement training needs. Ensures effective coordination with key home office units such as Marketing, Biopharm, sales and HR to maximize and integrate superior cross-functionality. Responsible for providing consulting expertise to other CMR Leaders, Global and HR partners on Talent Management and development strategies. May also provide input or implement global development and R&D training initiatives. Engages extensively with Talent Management peers and senior leaders as a credible expert and thought partner.

ESSENTIAL FUNCTIONS:
• Responsible for driving the establishment, implementation and maintenance of CMR, Training & Development programs, processes, metrics/strategies for CMR employees in partnership with the LoB, Talent Management, HR leadership and industry thought partners
• Responsible for the development and direct supervision over the CMR Academy
• Gathers input from CMR Leadership and Steering Committee to create a short and long-term training strategy
• Leads the needs analyses strategy which will assist in evaluating program design needs
• Collaborates with key stakeholders and regularly pays field visits to ensure in-depth understanding of market, individual/local needs and training is aligned with market/customer needs
• Accountable for budget records and prepares documents required for the budget review processes
• Develops requests for proposals; evaluates and provides input into vendor selection based on costs, qualifications and other pertinent factors based on the project; and coordinates legal review of finalized contract
• Applies adult learning and instructional design principles when developing materials
• Ensures ROI/Evaluation plans for the CMR Academy and other targeted learning interventions
• Leads the utilization of training design models, ensuring identification of effective knowledge and behavioral objectives, training strategies, outcome measures, and overall training effectiveness metrics and enhancement of capability
• Leverages Adult learning principles
• Conducts research and competitive analyses for developing and growing NNI’s CMR Training program to provide a leading edge continuum of development for professionals throughout their careers
• Develops and implements financially viable strategies and business plans for learning & development that are aligned with and support the Talent Management strategy and manages those plans through development and implementation
• Develops and measures the effectiveness and impact of tools, resources and systems by designing key processes to maximize achievement of objectives and focuses on continuous improvement
• Ensures all learning offerings are aligned with current and future strategies and coordinates execution of all stated programs to field and home office employees
• Manages vendors to ensure the seamless integration of high quality products with the learning curriculum
• Partners closely with Senior Leadership to ensure CMR Academy platform is utilized efficiently throughout CMR functions
• Oversees the planning and implementation for all large meetings
• Oversees the strategy, design and execution of on-boarding, phased training and guided electives
• Serves as primary liaison between CMR Training and the CMR Steering Committee and other key stakeholders
• Builds and maintains trusting, collaborative relationships and alliances with other key internal/external stakeholders

PHYSICAL REQUIREMENTS:
Approximately 25% overnight travel

DEVELOPMENT OF PEOPLE:
Develops team members through mentoring, coaching and sharing best practices. Ensures direct reports have 3P forms with annual goals and measurements consistent with business priorities and interim reviews are held so their work is focused on those priorities, and they understand their level of accountability for results and measurement process. Ensure that IDP forms include completed Learning and Aspiration plans are in place for all reporting personnel to enable achievement of goals and capability to assume increased levels of responsibility. Manages 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 required; Master's Degree preferred
• A minimum of twelve (12) years of progressive experience in CMR, Training & Development, Operations and/or Learning and Development
• A minimum of five (5) of managerial experience is required
• Pharmaceutical or healthcare experience is required
• CMR Training & Development experience is preferred
• Experience developing/executing executive and managerial leadership development programs highly preferred
• Must have thorough understanding and experience in the following areas: Training Needs Assessment; Training Strategies Development; Training Delivery; Learner Assessment; Training Program Evaluation; Training Program Design; Curriculum Development; Budget Allocation; CMR Fundamentals
• Must be knowledgeable in learning modalities (e.g. action/experiential learning, blended solutions, university programs)
• Must have strong strategic/business analysis and negotiation skills
• Must have demonstrated success in creating strategic direction and proven ability to implement and sustain business improvement and results
• Strong business acumen required
• Must have the ability to manage internal/external relationships
• Must have demonstrated ability to handle multiple tasks in a fast-paced environment
• Experience working in partnership with Senior HR Business Partners is strongly preferred
• Experience designing and implementing e-learning solutions strongly preferred
• Must have comfort level in formal presentation settings
Department HR - CMR TRAINING
Position Location US - Princeton, NJ
City Princeton
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-Director%2C-CMR-Training-&-Development-Job-NJ-08540/2577021/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Director%2C-CMR-Training-&-Development-Job-NJ-08540/2577021/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Sr. Business Support Coordinator - Clinical Contracts
Job Category Administrative
Job Description PURPOSE:

Position supports the functional objectives of the Clinical Contract Management organization by performing a variety of routine and complex activities in support of their functional processes, programs, and/or services.

RELATIONSHIPS:

Frequent inter and intra-departmental contact is required, as well as contact with individuals representing external clinical site organizations, requiring some explanation or interpretation. May provide guidance and assistance to lower level clerical positions.

ESSENTIAL FUNCTIONS:

Responsible for managing the start-up processing and administration of information related to clinical site contacts. May assist clinical contract project team with tasks related to project start-up, clinical conduct, and close out activities.

Demonstrates competencies in the technical, regulatory, legal, or other terminology specific to the appropriate functional processes.

Uses software and new/emerging technologies in performing the duties of the position.

Works independently on a variety of moderately complex and diversified department activities and projects; compiling and analyzing data, creating reports, providing information regarding function specific policies and procedures for applied use by management, and tracking and control of processes, projects, and activities.

Works under limited supervision, exercising some independent discretion and judgment, with some latitude to change work processes and work flow.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A high school diploma and a minimum of 4 years related administrative experience required.

Must possess experience utilizing the MS Office suite of products, including expert level proficiency using MS Word and MS Excel. Knowledge/experience using MS PowerPoint is a plus

Must possess demonstrated skills/aptitude in other PC applications, typically involving new/emerging technologies such as project management software and other computer software programs specific to
Department CMR - CLINICAL BUSINESS MGMT
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required High School Education Required]]>Thu, 16 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Business-Support-Coordinator-Clinical-Contracts-Job-NJ-08540/2602667/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Business-Support-Coordinator-Clinical-Contracts-Job-NJ-08540/2602667/?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 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%]]>Tue, 23 Apr 2013 03:00:00 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 Sun, 28 Apr 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/NJ-Associate-Director-Regulatory-Affairs-Medical-Devices-08540/2162279/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/NJ-Associate-Director-Regulatory-Affairs-Medical-Devices-08540/2162279/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Regional Clinical Research Associate (CRA)- Memphis, TN
Job Category Clinical
Job Description PURPOSE:
Responsible for performing study activities regarding the implementation, monitoring and summarization of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR.

RELATIONSHIPS:
Reports to a Manager/Senior Manager of Field Management (FM) 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:
• 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 resolve site related issues.
• 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.
• Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
• 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 CRAs as appropriate.
• Completes follow up letters from all visit types according to SOPs and completes 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.
• 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.
• 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 assuring adequate and appropriate dissemination of information according to the study specific communication plan between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan.
• 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, IVRS and updates, and ensure CSIM entries and updates are made.
• Responsible for maintaining focus, locally, for specific project activities within CMR priorities.
• 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 70% overnight travel to visit assigned sites for monitoring and attending trainings/meetings.
• Must live within 50 miles of the regional workload center within assigned region.

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 Bachelor of Science or a Bachelor of Arts in a scientific discipline. Advanced degree preferred.
• A minimum of 4 years of clinical trial experience within pharmaceutical and/or healthcare setting required, including at least 2 years performing in the role of an on-site monitoring CRA.
• 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.
• Must maintain a valid driver’s license and obey all applicable traffic laws.
Department CMR - FIELD MGMT MIDWEST
Position Location US - Field Based - Across US
City Memphis
State/Provinces US - TN
Degree Required Bachelor's Degree Required
Percent Travel 70 - 80%]]>Tue, 07 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Memphis-Regional-Clinical-Research-Associate-%28CRA%29-Memphis%2C-TN-Job-TN-37501/2535827/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Memphis-Regional-Clinical-Research-Associate-%28CRA%29-Memphis%2C-TN-Job-TN-37501/2535827/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title BRAND MANAGER - NOVOLOG
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. Leads cross-functional EBTs for designated brand and interacts extensively with the other functions within Novo Nordisk. Accountable for the implementation of marketing activities for assigned products both marketed and in development, while refining messaging to specific customer segment and ensuring brand alignment of all initiatives with COEs. Works closely with Marketing Effectiveness (ME) to establish, own and defend the brand forecast. 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. Works with Portfolio Leads to create POA "Call to Action".

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

ESSENTIAL FUNCTIONS:

Brand Planning:
• Accountable to manage the brand/portfolio budget process for designated area - makes sound decisions to optimize spend and ensure that resources are appropriately allocated and quality of services are maintained while costs remain on track and according to budget. Monitor agency expenses by looking for opportunities to maximize value while minimizing agency costs. Follow internal and external procedures in managing contracts. Regularly tracks and reconciles expenses to ensure budget is on track.
• Assists in developing and coordinating overall brand plan, ensuring alignment of brand positioning and messaging with COE’s.
• 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.
• Implement pre-marketing strategies, and develop clinical thought-leader relationships and involvement.
• Lead and/or assist in the development of plans and strategic marketing plans for new and current products. This includes working with the relevant units to ensure in-depth market analysis, effective market research activities, thought leader development, forecasting, pricing strategy, etc.
• Manage all aspects of the marketing mix including promotion, pricing, distribution, and product developments and/or changes.
• 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 for new product launches.

Brand Team Leadership:
• 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. Experience in the Diabetes Marketplace would be desirable.
• 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 - NOVOLOG / NOVOLOG MIX 70/30 (3a)
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 20 - 30%]]>Sat, 04 May 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-BRAND-MANAGER-NOVOLOG-Job-NJ-08540/2531553/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-BRAND-MANAGER-NOVOLOG-Job-NJ-08540/2531553/?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 Title Medical Liaison II - South Louisiana
Job Category Field Medical
Job Description PURPOSE:

Builds relationships and demonstrates the clinical outcome and benefits of NNI products. Educates and demonstrates the benefits of key products. Provides medical information and coordinates continuing education workshops.

Within Field Medical Affairs, the Medical Liaison (ML) position functions as a scientific liaison between NNI and key external customers to further scientific exchange. S/he provides product and field scientific support to Medical, Sales and Marketing, as well as Managed Care and Government by using academic credentials and scientific expertise to communicate with health care providers and organizations.

RELATIONSHIPS:

Additional key internal relationships are with the regional ML teams, Clinicians, Marketing, Managed Care & Government, and Sales personnel. External relationships include key opinion leaders (KOL’s), academic institutions, physicians, nurse practitioners, diabetes educators, and pharmacists. External relationships include but are not limited to: physicians; nurses; nurse practitioners; pharmacists; academic institutions; associations/societies; managed care organizations and HMOs.

Position reports to Field Director/Sr Field Director/ or Executive Director.

ESSENTIAL FUNCTIONS:

ADMINISTRATIVE DUTIES: Consistently complete administrative duties in an accurate manner and on a timely basis, in line with current SOPs and working practices.

Ensure effective administrative management of regional business as well as operational budgets.

Provide monthly reports on scientific support activities in region to Director including budget expenditures as directed.

Record all activities within the AdvantEDGE system in accordance with FMA procedures.

ADVOCACY & PROFESSIONAL RELATIONSHIP DEVELOPMENT: Attend assigned medical and scientific meetings to: a) maintain awareness of current issues and new data pertaining to NNI products; b) develop and maintain relationships with health care providers; c) support appropriate use of NNI products and greater utilization of its services d) support representatives in answering physician questions.

Identify academic centers and investigators to initiate and/or participate in clinical trials and identify key areas of future research.

Identify, contact, develop and maintain relations with health care providers to establish and/or further the knowledge of NNI products and their appropriate use; when necessary, assist in resolving issues pertaining to that use.

Identify, respond to inquiries and develop relationships with health care professionals; identifying those individuals with novel research concepts, clinical experience and expertise, within identified therapeutic areas of interest to Novo Nordisk Inc.

Maintain a thorough working knowledge of NNI, its products, current scientific research and publications associated with therapeutic area of interest.

Participate in special Regional projects e.g., team meetings, training, etc.

Prepare and conduct ongoing product and scientific updates for the Region as requested.

Profile and recruit qualified investigators to participate in company-sponsored activities (e.g., speaker, investigator, or consultant) as directed by Home Office.

EDUCATIONAL PROGRAMS: Assist in preparing training materials for the FMA team.

Assist with training sales representatives on product knowledge and understanding of technical information within the therapeutic area.

Coordinate the development of symposia and continuing education seminars for health care providers on subjects relevant to NNI’s products.

Deliver approved presentations at regional POAs, sales training, advisory board meetings and speaker training activities as directed.

Respond to unsolicited inquiries about Novo Nordisk’s grants and charitable contributions program.

FIELD-BASED CLINICAL SUPPORT: Attend assigned medical and scientific meetings to: a) maintain awareness of current issues and new data pertaining to NNI products; b) develop and maintain relationships with health care providers; c) support appropriate use of NNI products.

Collaborate with Marketing, and Sales management to develop scientific strategies to optimize NNI’s products and development activities in the medical community.

Coordinate with regional FMA team members to ensure integrated comprehensive coverage of regional clinical and scientific needs.

Develop and present product and scientific updates as requested using approved material.

Establish and maintain functional working relationships with Clinical Research Associates within the region to further scientific exchange.1

May coordinate on the identification and support of investigator-initiated studies in the region and refer requests for research grants from region to The Research Grants Committee.

Scientific and clinical support for marketed products and development projects

Support regional Field Sales’ scientific needs.

PHYSICAL REQUIREMENTS:

Approximately 60% travel with overnight.

DEVELOPMENT OF PEOPLE:

Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A PharmD degree required.

Advanced degree in health or biological sciences with professional licensure (e.g. RN, RD, Rph, etc) required.

At least two years experience in a health related system, pharmaceutical company, or managed care environment.

Certified Diabetes Educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM) preferred with Allied Health Professional degrees.

Displays business acumen/knowledge based on experiences such as participation in formulary process decisions.

Extensive experience in diabetes strongly preferred.

Strong communication skills.
Department CMR - SOUTH CENTRAL
Position Location US - Field Based - Across US
City New Orleans
State/Provinces US - LA
Degree Required Doctorate Degree Required
Percent Travel 60 - 70%]]>Tue, 07 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/New-Orleans-Medical-Liaison-II-South-Louisiana-Job-LA-70112/2535819/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/New-Orleans-Medical-Liaison-II-South-Louisiana-Job-LA-70112/2535819/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Regulatory Affairs
- Denmark - Søborg

Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine approved across the globe. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite challenging. Are you up for the challenge?

About the department
The RA Degludec Clinical Department is situated in the Novo Nordisk project house together with other regulatory functions in Søborg. We are a group of 10 highly skilled and dedicated people involved in continuing the global registration of Novo Nordisk’s newest insulin products, Tresiba® and Ryzodeg® as well as important activities related to Life Cycle Management.

Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business.

We are currently looking for a Regulatory Clinical Specialist with a science background combined with solid regulatory experience to join our team responsible for the worldwide approval and maintenance of Tresiba® and Ryzodeg®.

In collaboration with experienced regulatory professionals and associates you will be responsible for clinical aspects of regulatory affairs activities within the projects.

The job
You will be responsible for regulatory activities of strategic importance and compliance. It is important that you can drive, lead and execute in accordance with overall Regulatory Plans and Product Business Plans.

In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You’ll be expected to make an impact and challenge the status quo if that’s what it takes.

You will be a member of a global regulatory team and also work closely with other departments to achieve the ambitious goals of the project.

You will be involved in the planning of and responsible for preparation and maintenance of regulatory documents, the regulatory review of protocols and reports as well as working on worldwide submissions and the following interactions with health authorities. You will also be responsible for keeping up to date with current internal requirements and external guidelines and legislation within area of responsibility. Life cycle management activities will also be a part of the job.

The position has for the right person good development opportunities. Novo Nordisk offers a world of support with first rate professional training, relevant support groups and talented, friendly colleagues.

Qualifications
A strategic and analytical mindset coupled with ability understand details while maintaining the overview are key competencies for you

We expect you to have a university degree/Ph.D. in life sciences and documented professional experience working with regulatory affairs and/or the pharma industry. Project management experience is a plus. You are organised, a good planner and a proactive problem-solver, and you’re a skilled communicator who is comfortable speaking and writing in English.

As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work even when the pressure’s on. You’re a strong team player, but you also enjoy working independently.

At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.

We create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.

Contact
For further information, please call Jane Møll Pedersen on+45 3075 3759 or Dorrit Espersen +45 3075 8242.

Deadline
17 May 2013.]]>Wed, 08 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-Regulatory-Clinical-Specialist/2588275/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-Regulatory-Clinical-Specialist/2588275/?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
- Research & Development, Medical Doctor
- Denmark - Søborg

The Medical & Science, Degludec II department at Novo Nordisk A/S is seeking a physician to take on a position as International Medical Director/Manager working with diabetes projects in Novo Nordisk. We are looking for a medical doctor with documented clinical and scientific knowledge about diabetes. A candidate with experience from clinical development work within the pharmaceutical industry and knowledge about interaction with regulatory agencies will be preferred. The job will require strong interaction with highly engaged colleague’s world-wide and external stakeholders including treating physicians and therapeutic experts.

About the department
The department is medically responsible for planning and conducting clinical studies as well as medical input to regulatory documents and health authority interactions. The candidate will be involved in these activities closely interacting and collaborating with the NN organization globally.

The Job
Key responsibilities of the successful candidate will be to take up the role as Medical Specialist within the assigned projects. This includes being instrumental in creating regulatory documents, implement clinical development strategies for a drug candidate, updating Clinical Development Plans, executing clinical studies phases 1-3 and providing medical deliverables to the paediatric investigational plans for a drug candidate.

A specific focus will be to provide input to the content and quality of the regulatory documents, Clinical Part of the Submission Dossier as well as creating / writing relevant risk-assessment plans, medical content of trial outlines, protocols, clinical trial reports, paediatric investigation plans, IMPDs and publications and presentation of medical aspects of the clinical development program at internal and external meetings (including meetings with health authorities, congresses, investigator meetings etc.).

Qualifications
You have a medical degree including scientific training (PhD, DMSc or equivalent), and preferable knowledge within diabetes or metabolic conditions. It will be an advantage if you have previous experience from the pharmaceutical industry and experience from interaction with regulatory authorities e.g. NDA submissions, scientific advice or similar. You are a reliable, open-minded and dedicated team player, who thrives in a global environment of continuous development, and focuses on completion, quality and results. Interaction with internal and external experts require proficiency in English, high communication, coordination and planning capacities, as well as flexibility and a keen sense of quality. You may expect certain travelling activity of approximately 10%.

At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.”

Contact
For further information, please call Pernille Poulsen on +45 3075 9214.

Deadline
31 May 2013.]]>Wed, 15 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-International-Medical-Director-International-Medical-Manager/2545422/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-International-Medical-Director-International-Medical-Manager/2545422/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Research & Development
- Denmark - Måløv

Do you want responsibility for developing and managing people and optimizing work processes in a rapidly growing part of Novo Nordisk’s R&D organisation? Then we have a job for you.

About the department
CMC Clinical Supplies Labelling and IT (CSLIT) is responsible for a range of services supporting our clinical trials world-wide. Our clinical trial activity will be high in the coming years and to support this development, we are seeking a new team leader. Today, we are 45 engaged colleagues.

CSLIT occupies a central and cross-cutting role in the research projects. Therefore an important part of your role will be to ensure optimal collaboration with a number of internal and external partners in Denmark and abroad. This includes all our affiliates involved in Clinical trials, as well as suppliers of printed materials, labels etc.

You will report to the CSLIT Director and be a member of the department management team, which consists of 6 colleagues besides you. You will be located at Novo Nordisk’s site in Måløv.

The job
As team leader you will manage a team of 17 Labelling and Graphics co-ordinators, who are dedicated to design labels, booklets and directions for use for clinical research projects. All these are designed in-house, and some are printed in-house whilst others are printed by suppliers.

You will lead your team towards the achievement of challenging goals and timelines. Given the current high level in clinical trial activity, one key focus is on improvement of processes, reduction of lead time and increase of productivity. Therefore, you must be able to create and support a value set that drives a LEAN culture where continuous improvement is a natural part of everyday work.

You will be responsible for setting and meeting the team’s operational goals e.g. timely delivery of labels by ensuring effective allocation of people and resources to the various clinical trials. You thrive in working both with operational daily management as well as setting long term direction. You will act as sparring partner to your team - coaching and empowering team members to deliver timely and sound business results, and you will take an active and dedicated role in their own professional and personal development. As a member of the CSLIT management team, you will contribute actively in developing department strategies and targets, and in supporting a good working climate.

Your responsibility is to follow up on performance, focus on continuous improvement of processes, development of employees and last but not least the well-being of your team.

We offer you the opportunity to work in Novo Nordisk’s R&D organisation which is the largest R&D organisation in Denmark. We promise you constant challenge and the opportunity to be part of a dedicated and enthusiastic department as well as a dynamic management team. You will develop your managerial skills, work with many internal and external contacts internationally, and you will develop your personal competences and skills.

Qualifications
You have proven leadership and people management experience, preferably from line management. You have a proven ability to inspire and motivate others and to empower your team members to deliver high quality results. Experience from the pharmaceutical industry and/or GMP production and clinical trials will be a further asset. You are goal oriented and through your strong analytical skills you can identify, plan and overview many parallel business processes and prioritize the most value adding initiatives and ensure their implementation. Your personal leadership style is characterised by accountability, integrity and personal engagement.

You have an academic background.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please call Peter Christensen on+45 3079 2774 or Anne Mette Gam Kristensen on+45 3075 7150.

Deadline
5 june 2013.]]>Thu, 16 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/M%C3%A5l%C3%B8v%2C-Denmark-Team-Leader/2602664/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/M%C3%A5l%C3%B8v%2C-Denmark-Team-Leader/2602664/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Research & Development, Trial Manager
- Denmark - Søborg

Do you have experience in driving global clinical trials and do you want to exert your influence in a new therapeutic area by managing large global trials in rheumatoid arthritis or growth hormone disorders? Are you also prepared to embrace and tackle constant changes as part of your work each day? Then we may have just the right job for you.

About the department
Inflammation & Growth Hormone is the newest therapeutic area in Novo Nordisk. In Clinical Operations, Inflammation & Growth Hormone, we are now approx. 40 employees and we continue to grow as the pipeline matures. We are characterised by a world-class team spirit and quality mind-set, by our change readiness and an open, trust-based and creative working environment. We are responsible for the planning and implementation of clinical trial activities in accordance with the Clinical Development Plans in Inflammation and Growth Hormone, including trials in Rheumatoid Arthritis (RA), Crohn’s Disease (CD), Systemic Lupus Erythematous (SLE) and Growth Hormone Deficiency disorders. We collaborate internationally with other R&D units, with CROs and to a growing extent, with our Novo Nordisk affiliates.

The job
As International Trial Manager you will have responsibility for the international coordination of clinical trial activities. You will be responsible for ensuring that project key deliverables are met in time, at a high quality and within budget. You will be a member of the international study group, for which you will plan and conduct team meetings that maximise information sharing, stakeholder engagement and decision making. This includes vendor management of CROs participating in the trial execution. You will participate in and contribute to relevant investigator and monitor meetings.

The job requires that you apply a structured and analytical approach during development of relevant trial documents such as trial protocol, informed consent, recruitment strategies, risk analysis plans, communication plans and trial budgets. You are detail-oriented, while able to maintain overview, digest complex data and evaluate the adequate level of quality.

Qualifications
You hold an academic degree within the natural sciences or healthcare, and speak and write English fluently. You are a clear communicator and can inspire and motivate a team to deliver their best in an ever-changing environment. You have a good knowledge of clinical trial planning and execution and a minimum of 3 years’ experience in managing large clinical trials.

You have a quality mind-set, communicate effectively and know how to prioritise between different tasks in a dynamic environment which requires a high degree of flexibility. You work independently while also being a dedicated team player. You have excellent cross-cultural awareness and like to contribute to multi-cultural project groups.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

You will be part of a successful, expanding company in which working is not just a way to make a living, but a way to make a difference.

Contact
For further information, please contact Louise Høyer at +45 3075 1535 or David Mollerup at +45 3079 9133.

Deadline
9 June 2013.]]>Mon, 13 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-International-Trial-Manager/2595566/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-International-Trial-Manager/2595566/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS