http://www.novonordisk-jobs.com/feeds/nj-attorney-jobs/ Custom RSS Feed for nj-attorney-jobs Sat, 18 May 2013 19:23:01 GMT en-us /sites/novonordisk/images/Novo_Banner.gif http://www.novonordisk-jobs.com/feeds/nj-attorney-jobs/ 720 Title Sr. Attorney
Job Category Legal
Job Description PURPOSE:
Serve as legal counsel to global healthcare company with a focus on a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code.

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

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

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

DEVELOPMENT OF PEOPLE:
Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A J.D. with 6-8 years relevant industry or law firm experience. In-house experience preferred, but not required
• A State Bar admission required
• Experience within the healthcare/pharmaceutical industry
• Strong problem-solving and decision making skills with demonstrated ability to think creatively and devise solutions to challenging problems
• Exceptional written and verbal communications skills – able to effectively collaborate and communicate with stakeholders throughout the company
• Manage workload effectively, set priorities and deliver results on agreed upon timelines
Department LPQ - LEGAL/GOVT & QUALITY AFFAIRS (1b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Juris Doctorate Required
Percent Travel 10 - 20%]]>Thu, 25 Apr 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Attorney-Job-NJ-08540/2567597/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Attorney-Job-NJ-08540/2567597/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Legal Director, Privacy
Job Category Legal
Job Description PURPOSE:
Responsible for the development, implementation, and maintenance of the Novo Nordisk (NNI) Privacy strategy and program for North America.

RELATIONSHIPS:
Reports to Senior Corporate Counsel with responsibility for advising the company on privacy laws and regulations.

ESSENTIAL FUNCTIONS:
• Formulate enterprise-wide privacy policies and procedures, consistent with applicable U.S. and global laws
• Create content and guide delivery of roles-based education and awareness of privacy issues and their impact to our brand and business
• Act as the company’s privacy subject matter expert with knowledge of applicable state, federal and international laws and regulations including the FTC Act, CAN-SPAM, HIPAA/HITECH and related medical information privacy laws, laws and regulations related to employee privacy, and other global laws and regulations including those implementing the EU Data Protection Directives
• Provide leadership and oversight over cross-functional privacy committee including, but not limited to representatives from marketing, sales, human resources, clinical trial operations, medical affairs, IT, and corporate communications. Liaise with privacy function for NNI parent company to ensure compliance with global policies and procedures, and applicable laws
• Act as key point person (partnering with company stakeholders) for privacy data events/breaches with responsibility for implementing response plan and recommending any needed changes to business practices
• Maintain knowledge of external legal and industry developments in privacy including evolving laws and regulations, and proactively propose advisable business processes or practices
• Through on-going privacy risk assessments, identify areas of potential brand impact and legal consideration and propose and drive solutions
• Maintain knowledge of the relevant information technology systems and applications to drive systematic solutions and improvements
• Liaise with privacy professionals at peer companies and industry organizations
• Partner with company’s government affairs department on legislative and regulatory initiatives related to privacy affecting the company’s business

PHYSICAL REQUIREMENTS:
Not applicable

DEVELOPMENT OF PEOPLE:
Not applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree is required; JD preferred
• At minimum of 8-10 years of experience with at least 2-4 years of experience in a Compliance department or similar function for global company, with significant experience dealing with healthcare/pharmaceutical privacy matters
• Certification as a Certified Information Privacy Professional highly desired
• In-depth knowledge of applicable state, federal and international privacy laws
• Recognized subject matter expert within the privacy profession
• Experienced in successfully managing a comprehensive privacy program, with ability to prioritize, design, resource and implement program is preferred
• Demonstrated experience making sound risk assessments, and identifying and resolving legal and regulatory issues quickly and effectively and ability to make real-time decisions
• Proven track record as a strong team player with ability to work cross-functionally in a complex organizational structure
• Ability to communicate effectively at all levels of an organization
• Ability to work independently and be pragmatic and results focused
• Can take a dynamic approach to implementing a privacy program
Department LGQ - LEGAL/GOVT & QUALITY AFFAIRS (1a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%]]>Sat, 18 May 2013 05:31:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Legal-Director%2C-Privacy-Job-NJ-08540/2302733/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Legal-Director%2C-Privacy-Job-NJ-08540/2302733/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title ADMIN
Job Category Administrative
Job Description PURPOSE:
Performs clerical, administrative, or general office duties in support of a department/function or for one or more persons at the supervisory or middle management level.
RELATIONSHIPS:
Contacts are typically with individuals within own department and occasionally outside the organization, requiring some explanation or interpretation.

ESSENTIAL FUNCTIONS:
May independently research a wide variety of information requests; gather and compile reports, or analyze trends.
May perform duties on own initiative, such as review and respond to correspondence and preparing documents/forms.
May perform duties that are both task and project oriented requiring some interpretation and judgment.
Typically performs a variety of routine office duties similar to that of the Administrative Clerk involving typing, record and file maintenance, data entry, and meeting/travel arrangements.
Works under general supervision with instructions given for routine work and detailed instructions given for new activities or special assignments.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A high school diploma and 2-4 years administrative or related experience required.
Intermediate-level position requiring full knowledge of the job; substantial understanding of general office routines and procedures.
Must possess the ability to operate personal computer and associated office software.
Additional Information to be opened as Admin
job code: C584C
Department HR - GOVERNMENT AFFAIRS (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required High School Education Required
Percent Travel 0 - 10%]]>Mon, 22 Apr 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-ADMIN-Job-NJ-08540/2560225/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-ADMIN-Job-NJ-08540/2560225/?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 Pharma Field Sales - Diabetes Care Specialist (DCS) -South Coast, NJ
Job Category Field Sales
Job Description Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

Pharma Field Sales - Diabetes Care Specialist (DCS) -South Coast, NJ

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 15% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - JERSEY COAST
Position Location US - Field Based - Across US
City Cape May
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%]]>Tue, 14 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Cape-May-Pharma-Field-Sales-Diabetes-Care-Specialist-%28DCS%29-South-Coast%2C-NJ-Job-NJ-08204/2547551/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Cape-May-Pharma-Field-Sales-Diabetes-Care-Specialist-%28DCS%29-South-Coast%2C-NJ-Job-NJ-08204/2547551/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Senior Associate- Rebate Management
Job Description PURPOSE:
Ensures timely and accurate payment of routine and complex Commercial, Part D, Specialty and Trade rebate claims and contracts. Reviews and analyzes the results of rebate calculations and identifies and reports status and exceptions.

RELATIONSHIPS:
Reports to the Associate Director – Rebate Management. Interacts with Strategic Pricing, Finance, Contract Management and Compliance, Government Pricing, IT teams and field and home office management. External relationships include trade, managed care customers, field sales personnel and systems vendors.

ESSENTIAL FUNCTIONS:
DATA ANALYSIS AND REPORTING:
• Assists customers and management with questions or problems arising with contracts and troubleshoots issues regarding contract performance.
• Identifies and analyzes performance trends and provide recommendations to management.
• Identifies missing claims data and works with customers in gathering and obtaining this data.
• Inputs, reviews and validates, processes and analyzes routine and complex claims for rebate claim payments and adjustments ranging from $100 - $5M or more; ensures claims are paid within the required timeframes and conditions, as stated in the contractual agreements.
• Prepares and provides standard contract reports (i.e., sales, rebate pricing, reconciliation) to field sales and home office management.
• Reviews and analyzes contract terms and conditions of routine and complex contracts. Ensures data in validation and rebate systems reflect the contract terms for accurate processing.
SYSTEMS MAINTENANCE/CONTRACT ADMINISTRATION:
• Assists customers with basic questions or problems arising with contracts.
• Assists with implementing enhancements for data validation and rebate systems.
• Creates and maintains Managed Care, Part D, Specialty and Trade rebate agreements in the rebate system.
• Ensures that all activities meet internal and/or external service level agreements.
• Maintains rebate system with updated information, such as price changes and quarterly NMS.
• Maintains membership and formulary linkages in rebate system.

PHYSICAL REQUIREMENTS:
Approximately 5% overnight travel

DEVELOPMENT OF PEOPLE:
Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• Requires a minimum of 3 years relevant experience.
• A Bachelor's degree or equivalent experience may be substituted for degree when appropriate.
• Intermediate to Advanced skills in Excel required.
• Advanced PC skills required.
• Contracting and Pricing Knowledge and Expertise Required - Understands contracting concepts and processes and the impact of pricing activities on contracting. Applies knowledge of changes in laws and competitive landscape to make sound business decisions.
• Experience in using financial and/or statistical tools to analyze contract data required.
• Intermediate proficiency in Showcase Analyzer desired.
• Intermediate data validation and rebate systems(i.e. CARS, Model N, MCRview) skills or related systems required.
• Strong analytical, quantitative, and qualitative analysis skills required.
Additional Information to be opened as Sr Assoc- Rebate Management
Job code: A150M
Department FIN - REBATE MANAGEMENT
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 0 - 10%]]>Sat, 04 May 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Senior-Associate-Rebate-Management-Job-NJ-08540/2531550/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Senior-Associate-Rebate-Management-Job-NJ-08540/2531550/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Principal Statistician/Assoc. Director - Biostatistics
Job Category Medical Information
Job Description PURPOSE:

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

RELATIONSHIPS:

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

ESSENTIAL FUNCTIONS:

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

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

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

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

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

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A Ph.D. degree in biostatistics, statistics, or relevant areas required.
Six years of experience in pharmaceutical industry engaged in biostatistical support of clinical development with progressively increasing scope of responsibility.
Demonstrated ability to develop statistical methodology for analyses of clinical data.
Extensive knowledge of statistical computer programming skills.
Good communication and interpersonal skills.
Knowledge of regulatory requirement.
Knowledge of statistical concepts and techniques and of clinical trial principles.
Department CMR - BIOSTATISTICS & STAT PROG (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required]]>Sat, 18 May 2013 05:31:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Principal-Statistician-Assoc_-Director-Biostatistics-Job-NJ-08540/2557339/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Principal-Statistician-Assoc_-Director-Biostatistics-Job-NJ-08540/2557339/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SR EXECUTIVE ASSISTANT, DIABETES MARKETING
Job Category Administrative
Job Description PURPOSE:
Performs a wide range of the highest level of complex and diverse administrative duties of an exceptionally responsible and confidential nature requiring a high level of tact and discretion.

RELATIONSHIPS:
Reports directly into the Sr Vice President - Diabetes Marketing, and interacts with internal and external sources at the executive level on a regular basis. May provide direction/coordination of workflow to lower level clerical positions.

ESSENTIAL FUNCTIONS:
-Provides proactive and efficient calendar management and meeting facilitation; including resolving meeting scheduling challenges, comprehensive travel requests, DMLT and departmental meeting facilitation (including off-sites), and coordination of robust agendas/pre-reads/minutes
-Directs administrative activities, develops and organizes procedures, and uses considerable written and verbal communication skills to represent the department.
-Exercising discretion and judgment, works independently to solve a variety of complex and diversified special projects.
-Handles correspondence and requests for information on behalf of the executive.
-Independently researches and develops reports and budgets; draws conclusions and makes recommendations.
-Performs all duties of the Executive Assistant position while providing the highest level of secretarial and administrative support.
-Plans and prepares communications requiring skill, tact, persuasion, and/or negotiation to accomplish the objectives of the communication.
-Relieves executive of administrative functions; resolving conflicts and handling a wide variety of complex and confidential situations and time sensitive material.
-Under minimal supervision, works on a variety of complex and diversified special projects requiring a wide degree of creativity and latitude; input to changes in work processes and work flow is often required.
Additional Information KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
-A high school diploma and 8+ years of advanced administrative or secretarial experience required.
-Advanced secretarial or administrative education highly preferred.
-Most senior level non-exempt secretarial/administrative position; requiring in-depth knowledge of specialized functions; a wide and comprehensive understanding of the functions, practices, procedures, and policies of the organization and their application to complex problems and situations encountered.
-Must possess the ability to operate personal computer and associated software.
Department DM - DIABETES MARKETING
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required High School Education Required
Percent Travel 0 - 10%]]>Tue, 23 Apr 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SR-EXECUTIVE-ASSISTANT%2C-DIABETES-MARKETING-Job-NJ-08540/2562648/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SR-EXECUTIVE-ASSISTANT%2C-DIABETES-MARKETING-Job-NJ-08540/2562648/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title MANAGER - DIGITAL STRATEGY
Job Category Marketing
Job Description PURPOSE:
Accountable to assist in the development and implementation of Healthcare Professional Relationship Marketing initiatives to achieve key brand & company objectives. Responsible to develop and coordinate Center of Excellence (COE) area strategies and tactics based on brand/portfolio strategy. Ensures initiatives are aligned to key managed markets and brand strategies by proactively communicating with Brand team prior to implementation. Acts as the expert and strategist for designated customer segment; ensuring brand/portfolio alignment. Partners with Brand teams to identify key metrics and evaluates ROI/impact of programs; collaborates with brand teams in making course corrections if needed. Acts as the leader and point person for tactical execution within designated segment – drives the brand materials.

RELATIONSHIPS:
Reports to the Director, Digital Strategy. Interacts with all Brand Marketing functions, working in close collaboration with Brand Leads. Other internal relationships include Medical, Managed Markets, Corporate Communications and Public Affairs, Regulatory, Sales, and Legal. Will also interact with NN A/S on international eMarketing projects and outside organizations as required.

ESSENTIAL FUNCTIONS:

HCP RM Campaign Management:
• Provide direction on strategy development for maximizing the use of and return to Novo Nordisk for customer data for all programs implemented across brand teams.

Vendor Management:
• Work with fulfillment vendors or agencies of record to implement new programs.

Healthcare Professional Relationship Marketing Program Development, Implementation, Promotion and Monitoring:
• Assist in developing in depth knowledge of relevant HCP customers including demographic profile, channel and content preferences as basis for relationship marketing program development & execution.
• Assist in developing integrated, multi-channel communications strategies and tactics to drive healthcare professionals to NNI customer touchpoints, both on-line and off-line.
• Assist in the development and implementation of all NNI healthcare professional portals and external internet sites with ongoing content management functions for all NNI internet sites.
• Assure compliance with NNI Corporate Visual Identity standards.
• Ensure brand/portfolio alignment with customer segments (Payors, Patient Marketing, KOL & Speakers).
• Identify appropriate measurements & ROI, and develop comprehensive reporting to evaluate effectiveness of on line marketing campaigns with regard to format, placement and creative employed for each campaign.
• Identify opportunities to coordinate programs across multiple brands/portfolio to ensure scalability, cost savings and alignment.
• Maintain project vendor partners, budgets, schedules, testing and quality components.
• Participate in PRB/MLR review of NNI internet site(s).
• Participates on Extended Brand Teams (EBTs) – provides COE expertise on strategies/tactics related to relevant customer segment(s).
• Proactively communicate with Brand team to ensure message alignment and tactical “sign off” prior to implementation.
• Document all web development and content publishing processes in an SOP and ensure compliance.
• Maintain quality control of all NNI healthcare professional websites assuring no dead links, browser compatibility and other standard quality control processes.

PHYSICAL REQUIREMENTS:
Less than 10% overnight travel.

DEVELOPMENT OF PEOPLE:
Not Applicable.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s Degree in Marketing, IT or related field required. Advanced degree preferred.
• A minimum of 5 years of relationship, direct or database marketing experience demonstrating a steady career progression with increasing role of responsibility.
• Extensive knowledge and experience in managing projects.
• Familiar with relational database structures and database management applications.
• Planning, Execution and Follow-Up- effectively prioritizes and spends his/her time and the time of others on what is important. Develops accurate short and long term plans, forecasting and business analysis. Ensures timely execution and follow-up. Meets deadlines. Anticipates problems and roadblocks to avoid crisis management.
• The ability to think analytically, evaluate data and develop programs to test the effectiveness of tactics.
Department DM - DIGITAL STRATEGY (2)
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%]]>Mon, 06 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-MANAGER-DIGITAL-STRATEGY-Job-NJ-08540/2533915/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-MANAGER-DIGITAL-STRATEGY-Job-NJ-08540/2533915/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title ASSOCIATE DIRECTOR, MARKET APPROACH - OBESITY
Job Category Marketing
Job Description PURPOSE:
• Leads the process of cross-functional coordination (including identifying and managing interdependencies). Manages the US Market Approach core project team contribution process and meetings and becomes the contact person for Obesity Market Approach strategy within and outside of the Obesity team (across both Global and NNI).
• Leads US Obesity Market Approach initiative, including: Conducting and pressure testing analyses required to understand stakeholder landscape & develop Market Approach options. Drawing conclusions and synthesizing insights from analyses. Developing recommendations for the Market Approach model in Obesity, including the critical arguments that support the recommendations, in collaboration with US Market Approach core project team. Preparing for the implementation of the Market Approach model for Obesity including creating and executing on a detailed implementation work plan with clear milestones, deliverables, roles and responsibilities and KPIs. Overseeing execution/implementation of Obesity Market Approach strategy in collaboration with core project team and relevant cross-functional partners.
• Regularly communicates perspectives, findings and insights to Brand Director, VP of Obesity and broader Obesity team and prepares Market Approach related communications to relevant decision-making bodies.

RELATIONSHIPS:
Reports directly to Obesity Brand Director. Member and Secretary of the Market Approach project team. Works closely with Sales, Medical, Market Access, Commercial Effectiveness, HR, Legal, Compliance, Finance and other relevant groups related to field resources to ensure alignment in implementation plan and roadmap.

ESSENTIAL FUNCTIONS:

Market Approach Model design:
• Conducts targeted analyses related to Obesity Market Approach model on an as-needed basis and pressure tests others’ analyses; synthesizes insights and forms recommendations.
• Continually stays on top of Obesity market landscape including competitive dynamics; takes action to adjust Market Approach model for changes.
• Defines and drives Obesity Market Approach initiative design, direction, goals, priorities and deliverables.
• Designs multi-year roadmap to rollout Obesity Market Approach model with clear activities, milestones, accountabilities, KPIs and dashboards; pressure tests / syndicates with relevant NNI & Global stakeholders.
• Facilitates high-impact, cross-functional meetings that shape and drive the Obesity Market Approach initiative with relevant NNI and Global stakeholders.
• Regularly reports out insights, progress updates and recommendations to Obesity Leadership, NNI Market Approach and other relevant decision-making bodies; prepares project documents and helps Brand Director and VP of Obesity with meeting planning and execution.

Market Approach Model implementation:
• Creates and leads pilots for select elements of Obesity Market Approach Model; analyzes results and tailors Market Approach Model accordingly.
• Leads financial scenario planning and budget proposal submissions for Obesity Market Approach initiative activities/projects.
• Liaises with HR, Legal and Compliance to oversee the hiring, onboarding, training and deployment of new resources as part of the Obesity Market Approach initiative.
• Manage the application and communication of all Novo Nordisk policies, procedures, and the Novo Nordisk Way.
• Manages vendor relationships (e.g., external consultants) related to Obesity Market Approach initiative.
• Oversees overall execution of Market Approach Model implementation.
• Regularly tracks Obesity Market Approach initiative’s progress against KPIs, updates dashboards and refines/adjusts Obesity Market Approach as the Obesity landscape evolves.
• Works closely with communications experts within NNI to develop change management plan and manage communications strategy related to Obesity Market Approach initiative.

PHYSICAL REQUIREMENTS:
Approximately 20% overnight travel.

DEVELOPMENT OF PEOPLE:
Not Applicable.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• 5+ years of experience in marketing or sales in the health care or life science businesses required.
• 5+ years of program management experience with a track record of leading complex cross-functional projects required.
• Bachelor’s degree required, advanced degree or MBA highly preferred.
• Excellent written and verbal communication and interpersonal skills required.
• Knowledge of the Obesity therapeutic area preferred but not required.
• Must excel in strategy development, project management, business analysis, problem solving, executive communication and consensus building.
Department DM - OBESITY (2a)
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%]]>Tue, 07 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-ASSOCIATE-DIRECTOR%2C-MARKET-APPROACH-OBESITY-Job-NJ-08540/2585884/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-ASSOCIATE-DIRECTOR%2C-MARKET-APPROACH-OBESITY-Job-NJ-08540/2585884/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title DEM - CAROLINAS
Job Category Marketing
Job Description PURPOSE:

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

RELATIONSHIPS:

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

ESSENTIAL FUNCTIONS:

MANAGEMENT

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

PLANNING AND FIELD-BASED SUPPORT

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

COORDINATION OF EDUCATIONAL PROGRAMS

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

ADMINISTRATIVE DUTIES:

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

DEVELOPMENT OF PEOPLE:

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

KEY SUCCESS FACTORS:

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

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

OTHER:

• Works within Novo Nordisk’s established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
• Embraces Novo Nordisk Values in spirit and actions.
• Approximately 50% overnight travel.
Additional Information to be opened as DEM- Carolinas
job code: S064A
Department DM - CAROLINAS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 50 - 60%]]>Thu, 09 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-DEM-CAROLINAS-Job-NJ-08540/2590577/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-DEM-CAROLINAS-Job-NJ-08540/2590577/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Sr. Associate/Specialist, Reg Affairs Operations-Submissions Publisher
Job Category Regulatory Affairs
Job Description PURPOSE:

The Regulatory Operations Senior Associate/Specialist will support the global extent of e-submissions and use of Insight Publisher and/or Novodocs for regulatory submissions in Novo Nordisk and will identify, analyze and develop technical solutions that improve Regulatory Affairs (RA) business processes, using available desktop technologies. Additionally, he/she will be responsible for ensuring accurate, consistent and timely submission planning and tracking data entry for Insight Manager.

RELATIONSHIPS:

The Regulatory Operations Senior Associate/Specialist will report to a Manager of Regulatory Operations & Innovations and will interact with the Therapeutic Areas (TA), SMART, Promotional Review, Product Safety and ROI.

ESSENTIAL FUNCTIONS:
? Responsible for the management, publishing and submission of eCTD submissions, including major filings
?Will help the Manager of Regulatory Operations manage tracking, coordinating, publishing, and submitting of all product submissions.
?Will also be required to update epub information as needed and timely archive submissions following internal procedures.

?Processes electronic files incorporating bookmarks, links and other formatting requirements and transmits these for filings and related regulatory notifications in accordance with established timeframes.

E-SUBMISSIONS PLANNING, TRACKING AND REPORTING AUTOMATION:

Primarily responsible for ensuring accurate, consistent and timely data entry for the Insight Manager application, including Record of Contact (ROC) entries and commitment tracking activities. The Regulatory Operations Senior Associate will configure Insight reports supporting RA customers’ needs. Additionally, the Regulatory Operations Senior Associate will develop or configure Crystal Reports solutions for Insight-related reports (submission planning and tracking, metrics, and portfolio and QMR data reporting). Finally, using InfoView and Sharepoint, he/she will automate distribution and delivery of reports to the end user.

OFFICE AUTOMATION SOLUTIONS FOR RA:

Working with the RA business areas, the Regulatory Operations Senior Associate/Specialist will identify, analyze, develop, pilot, and implement technology solutions for improving efficiency, quality, timeliness and cost. Solutions will be developed on a variety of available desktop software suites. The Regulatory Operations Senior Associate will also develop, manage, and grow the new Globeshare platform for Intranet content and teamsite solutions. Responsible for developing solutions that are both technical documentation as well as appropriate training materials.

SUPER USER SUPPORT AND TRAINING FOR KEY DEPARTMENTAL APPLICATIONS:

The Regulatory Operations Senior Associate/Specialist will promote and champion the use of existing and future technology platforms to quickly address evolving business needs.

The Regulatory Operations Senior Associate/Specialist will serve as first line support for key RA applications such as novoDOCS, epub (Insight), Globeshare, and InfoPath. Additionally, as SuperUser will help deliver and support rollout training activities and develop RA-specific training documentation.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

Bachelor's Degree or equivalent, with a minimum of 2 -4 years (higher for Specialist level) relevant regulatory experience.
IT competency is a plus especially in MS Office, InfoPath, Sharepoint
• knowledge of eCTD publishing
• Understanding of the eCTD structure as well as FDA and ICH specifications for eCTD submissions.

• Previous hands on experience with the eCTD processes behind the compilation of INDs/NDAs/Amend/Supplements
Department CMR - OPERATIONS & ARCHIVE
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience]]>Fri, 17 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Associate-Specialist%2C-Regulatory-Affairs-Operations-Job-NJ-08540/2366236/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Associate-Specialist%2C-Regulatory-Affairs-Operations-Job-NJ-08540/2366236/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Senior Accountant
Job Category Finance
Job Description PURPOSE:
Responsible for overseeing the monthly closing process including ensuring compliance with Sarbanes Oxley § 404 Controls (Sarbox) and Novo Nordisk Corporate Accounting guidelines. In addition, the Senior Accountant will undertake moderately complex accounting assignments, and will be the department’s SAP and Business Warehouse (BW) “super user” providing training and problem solving to all users.

RELATIONSHIPS:
Reports to the Accounting Manager. Position interacts across the Novo Nordisk Inc. (NNI) Finance and Global Shared Services Center (GSSC) India on a daily basis, providing support, guidance and review of work. There is frequent interaction with NNI Line of Business (LoB), Corporate Finance, other affiliates particularly with respect to North American (NA) Shared Services. Other relationships include the NN SAP solution center, government agencies, internal and external auditors.

ESSENTIAL FUNCTIONS:
• Responsible for month-end closing process including preparation of accruals and schedules for the Annual Questionnaire
• Key liaison with internal/external auditors for the documentation and support of key accounting and reporting risks and controls
• Ensures financial postings are prepared in accordance with Corporate Policies and Sarbox requirements for NNI and affiliates with respect to NA Shared Services
• Reconciles & analyzes selected General Ledger accounts including preparing adjustments
• Provides guidance and training to less experienced staff including reviewing of the activities performed by GSSC, i.e., cash processing, fixed asset postings, journal entries preparation, cost center updates, reconciliation and other ad-hoc projects
• Supports ad-hoc projects and shared services provided to affiliates including Novo Nordisk Research Center in Seattle, Global Development in Princeton, or other R&D related chargeback cost centers
• Interacts with cost center managers and LoB to make recommendation on SAP accesses and cost center hierarchy set up
• Assists LoB with variance analysis and prepares depreciation and chargeback forecasts for incorporation into NNI’s rolling forecasts and annual budget
• Prepares financial statements and footnotes for NNI, relevant NA affiliates, and NNI Pension and Benefit Plans
• Coordinates, gathers and consolidates financial information from the NA affiliates for filing of mandatory financial reporting with various US Government Agencies
• Develops and provides SAP & ad-hoc training to users
• Performs User Acceptance Tests during SAP and accounting related system upgrades
• Identifies and provides solutions to support finance process improvement as well as cLEAN initiatives

PHYSICAL REQUIREMENTS:
Not Applicable

DEVELOPMENT OF PEOPLE:
Not Applicable

TRAVEL REQUIREMENTS:
0-5% required

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• Requires a minimum of 4 years relevant experience in Accounting and Financial Reporting
• A Bachelor’s Degree is required; relevant experience may be substituted for degree when appropriate CPA or equivalent is preferred
• Pharma and prior leadership experiences are helpful
• Experience working within a large ERP system environment, SAP experience a plus
• Strong knowledge on accounting controls and processes in ERP environment
• Strong oral and written communication skills with the ability to interactive closely with various departments and levels internally
• The ability to work independently on accounting issues with some guidance, and have an understanding of applicable laws and requirements
• Strong process orientation with a strong attention to detail
Department FIN - CONTROLLER (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 0 - 10%]]>Thu, 25 Apr 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Senior-Accountant-Job-NJ-08540/2567594/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Senior-Accountant-Job-NJ-08540/2567594/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Associate Manager- Financial Controls & Compliance
Job Category Finance
Job Description PURPOSE:
To ensure that all Sarbanes Oxley (Sarbox) relevant control activities are maintained in compliance with Company and regulatory standards for Novo Nordisk Inc (NNI) and to recommend clear and concrete approaches for improving internal controls and operational effectiveness and efficiency. This position will also assist the Line of Business in maintaining reasonable operational controls to prevent/detect exposure to waste, inefficiencies or misappropriation of the company’s assets.

RELATIONSHIPS:
This position reports to the Manager, Financial Controls and Compliance. This position will also interact across all levels of NNI Finance, and works closely with other functions throughout NNI. The position will frequently interact, coordinate and build strong relationships with Novo Nordisk’s Sarbox Consulting, Group Internal Audit (GIA) and external auditors.

ESSENTIAL FUNCTIONS:
• Leads the process owners’ Sarbox documentation effort to verify alignment of identified risks to Sarbox controls, maintain/adjust new/existing controls.
• Coordinates and leads the execution of Sarbox reviews by Sarbox Consulting, corporate GIA and external auditors. Verify audit readiness and monitor remediation efforts with process owners.
• Supports the implementation and changes to financially-critical systems. Reviews RFC’s (Request for Change) and/or BIA (Business Impact Assessment) for Sarbox/financially critical systems. Documents Sarbox assessment and reviews test scripts to verify controls to mitigate Sarbox risks are properly addressed.
• Provides consultative support to process owners to improve Sarbox documentation including ICQ-Internal Control Questionnaires and R&M-Risk & Materiality documents.
• Leads the Sarbox awareness initiative via communication and training.
• Provides partnership, oversight and direction to business leaders regarding financial controls and compliance.
• Conducts and leads the financial, operational, or fraud control audits for internal processes or suppliers, which focus on internal controls, general process/efficiency recommendations, or compliance with contract terms. Prepare draft report of the audited area and communicate findings to senior management.
• Develops and communicates compelling, fact-based rationales with strong, logical arguments that builds support for findings and perspectives.
• Provides partnership, oversight and direction to business leaders concerning process and internal control improvement opportunities.
• Leads the management of fraud risk assessment matrices (i.e. documentation of fraud risks, controls, and responses).
• Conducts and leads the evaluation and testing of the effectiveness of internal controls surrounding prevention/detection of fraud.
• Performs SAP annual critical access and Segregation of Duties review of key financial systems, working with relevant department managers. Verify access is properly segregated or mitigating controls exist.
• Manages targeted audit sampling testing of transactions (e.g. credit card, invoice, vendor activities, etc.) and report findings to management. Query transactions to support audit analytics.
• Demonstrates knowledge of internal business operations and industry best practices; and applies this knowledge to analyses, processes and deliverables.

PHYSICAL REQUIREMENTS:
5% - 10% overnight travel to Corporate Headquarters in Denmark and to other North American locations.

DEVELOPMENT OF PEOPLE:
Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• Bachelor's degree required. CPA or CIA is required. Specified degree in finance, accounting or other business related area is preferred.
• Requires a minimum of 5 years of progressively responsible, relevant experience in internal auditing or public accounting. Pharmaceutical industry experience preferred.
• Sarbanes Oxley compliance experience preferred.
• Previous exposure to large ERP financial systems and environment is required, SAP experience a plus.
• Strong analytical skills with a high attention to detail. Ability to leverage data from multiple sources to understand business problems and assess the effectiveness of programs and practices.
• Experience with data mining and data query utilizing ACL or comparable system is a plus.
• Demonstrated ability to change quickly and manage multiple priorities with tight deadlines.
• Excellent verbal and written communication both in informal and presentation setting.
• Ability to build relationships with internal and external customers and stakeholders.
• Demonstrated ability to provide influential counsel and coaching to business leaders.
• Ability to lead a project in the development and implementation of processes and programs.
• Ability to utilize knowledge of the project management cycle, including stakeholder analysis, change management, execution and analysis to ensure the successful completion of projects.
• Strong skills in the use of the Microsoft Office Suite, particularly Excel and PowerPoint.
Department FIN - FINANCIAL CONTROLS & COMPLIANCE
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%]]>Mon, 29 Apr 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Associate-Manager-Financial-Controls-&-Compliance-Job-NJ-08540/2572215/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Associate-Manager-Financial-Controls-&-Compliance-Job-NJ-08540/2572215/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS 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 Senior Project Manager
Job Category Information Technology
Job Description PURPOSE:
Converts Information Technology strategy into reality through execution of high priority, complex projects. Uses appropriate tools and techniques to successfully manage projects according to the triple constraints of scope, timeline and budget while fulfilling quality requirements and managing risks. Ensures IT strategy has proper business alignment. Manages and leads project teams, vendors and stakeholders so that stated project objectives, benefits and solution requirements are met.

RELATIONSHIPS:
Reports to the Director, IT Project Execution. Partners with internal Information Technology colleagues as well as with Line of Business key stakeholders in the execution of key initiatives. High level of interaction with external vendors.

ESSENTIAL FUNCTIONS:
ANALYZES & FULFILLS BUSINESS NEEDS
• Collaborates with business leaders to identify and prioritize projects to ensure the delivery of on time and quality solutions.
• Engages stakeholders to discuss the effectiveness of solutions and capabilities and their impact on business strategies and procedures.
• Leverages in-depth knowledge of business functions, business processes and key objectives to develop solutions aligned with business needs.
• Participates in the project portfolio process and IT strategy development.
BUILDS RELATIONSHIPS & INFLUENCES KEY STAKEHOLDERS
• Collaborates closely with other Line of Business (LOB) Project Managers and IT staff to leverage technology and resources across business areas.
• Develops partnerships with assigned business area(s) to understand their strategic direction and researches/evaluates new and future technologies to address business needs.
• Facilitates cross-functional collaboration among necessary stakeholders when making decisions and developing strategic plans.
• Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding IT policies, solutions and initiatives.
DEVELOPS & EXECUTES IT STRATEGIC PLANS
• Collaborates with other functional areas to develop and deploy solutions that impact multiple areas in the organization.
• Contributes to the development and maturing of “Project and Process services” and Information Technology in general.
• Identifies project opportunities and pursues them from idea to post implementation.
• Leverages in-depth knowledge of the business and industry to develop strategies and initiatives consistent with Novo Nordisk, and global and local functional objectives and business needs.
MANAGES IT PROJECTS
• Act as the key contact for externally hosted applications, as necessary. Oversee any change requests or performance related questions or issues.
• Conducts project meetings with the line of business to discuss the scope and the approach of the project.
• Ensures responsibilities are appropriately assigned across cross-functional teams and ensures that each team member is contributing in accordance with the goals and project deliverables.
• Ensures solutions implemented are successfully handed over to responsible units, such as IT Systems Management, to manage future lifecycle of the solution.
• Negotiate with the business, and other stakeholders, when necessary to manage project changes.
• Provides strategic leadership to large cross-functional projects using the Novo Nordisk IT project management methodology.
• Reviews the project with assigned business analyst to ensure their understanding, discuss roles, responsibilities, expectations and timelines for requirements gathering.
• Utilizes knowledge of system development lifecycle to anticipate potential barriers, provide solutions and ensure the successful completion and handover of projects.
MANAGES IT VENDORS
• Manages project plans or service level agreements and budgets to ensure that vendors deliver services within scope, schedule, quality and budget estimates.
• Reviews and develops requests for proposals, evaluates and finalizes vendor selection based on costs, qualifications and other pertinent factors based on the project or service delivery and coordinates legal review of finalized contract.
UNDERSTANDS & APPLIES RISK MANAGEMENT PRACTICES
• Ensures departmental project and QA requirements are fulfilled and adhered to.
• Incorporates quality systems into all stages of the project/lifecycle to ensure deliverables meet quality requirements.

PHYSICAL REQUIREMENTS:
Approximately 15% overnight travel

DEVELOPMENT OF PEOPLE:
Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• A BS degree in Computer, Natural Science, Math or Business Administration is required. A MS/MBA degree is preferred.
• A minimum of 10 years progressively responsible experience with 3-4 years in project management required.
• Certification in Project Management or Lean Processing Methodology preferred.
• Demonstrates functional/business understanding.
• Demonstrates leadership skills; has the ability to acts as project lead and lead cross functional project teams in the development and implementation of programs.
• Demonstrates superior written and oral communication skills.
• Excellent skills with Microsoft Office.
• Extensive knowledge of project management and the development life cycle required.
• Has the ability to influence others on objectives and projects outcomes.
• Is proficient at problem solving, negotiation, conflict management, and interpersonal skills.
Department FIN - IT PROJ EXEC / COMMERCIAL FCNS (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%]]>Sat, 04 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Senior-Project-Manager-Job-NJ-08540/2581464/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Senior-Project-Manager-Job-NJ-08540/2581464/?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 Sr. Manager/Associate Director,Regulatory Affairs - Promotional Review
Job Description PURPOSE:

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

RELATIONSHIPS:

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

ESSENTIAL FUNCTIONS:

FDA COMPLIANCE:

Assure full regulatory compliance of all promotions with approved labeling.

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

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

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

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

PRB PROCESS:

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

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

Builds a strong relationship with the FDA

Other duties as deemed appropriate by Director, PRB.

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

Regulatory PRB reviewer.

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

SUBMISSIONS:

Assure company compliance with FDA and FTC requirements and strategy.

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

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

PHYSICAL REQUIREMENTS:

Some travel required.

DEVELOPMENT OF PEOPLE:

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

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

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

Review subordinates 3P and IDP’s.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A Bachelors Life Science degree required; advanced degree preferred.

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

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

Detail & deadline oriented; well organized.

Excellent verbal & written communication skills.

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

Works independently with minimal supervision.
Department CMR - PROMOTIONAL REVIEW
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%]]>Tue, 23 Apr 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Manager%2C-Regulatory-Affairs-Promotional-Review-Job-NJ-08540/2224770/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Manager%2C-Regulatory-Affairs-Promotional-Review-Job-NJ-08540/2224770/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SPECIALIST - MARKETING MATERIALS PRODUCTION & DISTRIBUTION
Job Category Marketing
Job Description PURPOSE:
This position has the responsibility of working with the brand marketing teams as well as other key functional areas of the organization in the production and distribution of all promotional materials. The Specialist - Production and Distribution coordinates all phases of production for marketing materials and works closely with agency partners on specifications for marketing materials requiring production. The Specialist - Production and Distribution is responsible to manage vendor relationships, manage bidding in Noosh system, work on comps and sampling as needed and plan delivery of produced materials, track progress, and assure and maintain complete and accurate files for all produced promotional pieces. He/she also assures quality control of all production and manages the verification process for proofs and production pieces prior to distribution to the field force or public. In addition, he/she will be responsible for distribution coordination of each individual piece. Performs ad hoc projects, as needed.

RELATIONSHIPS:
Reports to the Senior Manager, Production and Distribution. Primary interaction is with all levels within the primary focus areas including but not limited to Diabetes and BioPharm Marketing teams, Sales Training, Trade and Corporate Communications. Closely aligns with Managers of Marketing Operations on PRB process and workflow as well as the Fulfillment Services Consultant on the distribution of promotional materials. Externally, interacts with suppliers and agencies.

ESSENTIAL FUNCTIONS:
Distribution & Inventory Management:
• Ensures all proper documentation has been completed for each promotional item and communicated to the Fulfillment Services Consultant.
• Ensures compliance with 5 day dissemination policy as it relates to FDA submission of promotional materials.
• Ensures compliance with policy of mandatory review of materials disseminated more than 24 months prior.
• Manages 24-month review for inventory within Distribution Vendor.
• Manages distribution of materials in specific area of responsibility once PRB process is completed.
• On site visit to distribution vendor(s), as needed.
• Responsible for inventory management of promotional items and notifying Marketing Advocate status related to quantity on hand, low stock notifications etc.

Manages the Print Production Process:
• Align with print supplier & Fulfillment Services Consultant to ensure timely delivery to our Fulfillment supplier and dissemination as instructed by advocate.
• Analyze bid responses using pricing, timing and capabilities requirements from vendors and award project.
• Tracks status and costs associated with production projects.
• Ensures Final Production Verification for all Marketing Materials that have been PRB reviewed and manages filing of the verification forms and one production piece. This can include print out for larger materials or copies of slide decks/websites on DVD/CD. Filing will be on site for approximately 6 months and then manage process to archive with off-site vendor.
• Manage internal review and approval of proofs from print supplier.
• Manage print suppliers throughout production process.
• Manages Print Proof Verification for all print production jobs he/she initiates.
• Manages print specifications within Noosh procurement system.
• On-site visits to print/production vendors, as needed.
• Through Noosh, bid project using the triple-bid system to three of our preferred suppliers.

Works with brand marketing teams on production needs of marketing materials:
• Coordinates and participates in agency production calls to monitor and track status of produced tactics as needed.
• Creates and maintains production status reports.
• Works with brand management to provide project management and tracking support throughout the marketing materials proof and production process.
• Works with brand marketing teams and their advertising agency to develop proper specification sheets for production for marketing materials.

PHYSICAL REQUIREMENTS:
Not Applicable.

DEVELOPMENT OF PEOPLE:
Not Applicable.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• At least 5 years’ experience in management of marketing materials in the pharmaceutical industry or equivalent experience.
• B.S. Degree or equivalent experience desired.
• Ensures timely planning, execution and follow-up: effectively prioritizes and spends his/her time and the time of others on what is important.
• Leadership, communication, change management, influencing, and networking skills are critical.
• Minimum of 2-3 years of experience with warehousing and fulfillment of all promotional material as well as knowledge of various stakeholder reports and overall knowledge of the fulfillment process.
• Minimum of 2-3 years of print production experience. Complete project management including bidding and awarding projects, proof review and approval.
• Must be deadline oriented and able to handle multiple tasks.
• Must be highly organized and attentive to details.
• Must be skilled at identifying critical events in the process and interacting with agencies, suppliers, marketing and other business functions in communicating and resolving issues. Anticipates problems and roadblocks to avoid crisis management.
Department DM - MARKETING OPERATIONS (2)
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel None]]>Mon, 22 Apr 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SPECIALIST-MARKETING-MATERIALS-PRODUCTION-&-DISTRIBUTION-Job-NJ-08540/2560231/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SPECIALIST-MARKETING-MATERIALS-PRODUCTION-&-DISTRIBUTION-Job-NJ-08540/2560231/?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