About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk Inc. (NNI) is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the Food & Drug Administration (FDA) to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?
Assists the Executive Director in developing and implementing the medical affairs strategy within Growth Hormone. Coordinate medical activities linked to the brand in conjunction with the Executive Director. Assists the Executive Director in managing 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, Field Medical Affairs (FMA), Managed Markets/Market Access, and Sales. Assist with the development of strategies to appropriately position the Brand as part of the Novo Nordisk portfolio. Represent medical affairs in promotional review board (PRB) activities.
This position reports directly to the Executive Director- Medical Affairs- Biopharm and will assist the Executive Director in managing multiple internal relationships within Novo Nordisk Inc. and Global Headquarters. External relationships include expert advisory board members, investigators, other consultants, and key customer groups. Contribute to Publication Planning Group (PPG) and Brand’s Extended Brand Team (EBT).
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 Executive Director may serve as a representative of NNI 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.
Medical Communications: Assists in developing independent medical education strategy (Continuing Medical Education (CME), medical grants, AMCs/professional societies), incorporate into 5-year plans, and assess educational outcomes. Assists in the development of publications strategy (primary, secondary and Health Economics and Outcomes Research (HEOR)), with input from Medical Operations, and Global Publications. Provides medical input to manuscripts based on clinical trial results and on general topics inside relevant therapeutic area. Reviews brand-specific promotional materials (finalized medical input for PRB). Supports Medical Information and Field Medical Affairs units.
Regulatory & 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 Executive Director in ensuring quality execution by collaborating closely with North American Clinical Operations (NACO) 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 product portfolio and understanding of various Federal and Pharma regulations and guidelines as well as in depth knowledge of disease state. Supports the definition and implementation of the Brand’s labeling strategy.
Sales & Medical Support: Leads assigned advisory boards. Assists the Executive 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 Executive Director in making presentations as appropriate to external groups such as academic and community medical departments, professional associations, and Pharmacy & Therapeutics (P&T) committees.
Strategy & Protocol Development: Assist Executive Director in collaboration with global publication planning team along with NNI Medical Operations. Assist the Executive Director in developing and executing phase 3b/4 trial strategy including prioritization criteria, with input from Regulatory, Marketing and Global, and incorporate into annual and five-year plans, formalizing template and process to streamline protocol design, and developing Investigator Sponsor Studies (ISS) strategy, including prioritization criteria, and support its execution. Collaborate closely with HEOR group, 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 Executive Director, build relationships and maintain a strong Key Opinion Leader (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. Provide medical/scientific input into the Brand’s development and marketing strategies in consultation with the Executive Director. Provides content and ideas for publications run by Medical Operations. Reviews ISS proposals.
20-30% overnight travel required
- M.D. or D.O. and 5 years’ experience, with clinical and prior direct patient care experience required.
- Research or pharmaceutical industry experience in Growth Hormone 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 Medical Affairs tools.
- Expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS and medical education.
- Subspecialty training in endocrinology and metabolism preferred.
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Requisition ID: 59259BR
Job Category: Regulatory