Assists the Sr. Medical Director in developing and implementing the medical affairs strategy within Diabetes, Obesity or Biopharm. Coordinate medical activities linked to the Brand in conjunction with the Sr. Medical Director. Assists the Sr. Medical 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, 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 Sr. Medical Director and will assist the Sr. Medical Director in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. External relationships include expert advisory board members, investigators, other consultants, and key customer groups. Contribute to PPG and Brand’s EBT.
* 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. COMMUNICATIONS/TRAINING: In conjunction with the Sr. Medical Director may serve as a representative of Novo Nordisk Inc. Medical department in regulatory interactions, investigators’ and expert advisory board meetings, external professional societies, seminars, and conventions.
* Maintains required credentials and remains in good standing within the medical community and medical ethics boards.
* Stays abreast of regulatory requirements and guidelines and current trends and medical practice in relevant therapeutic area, including reports and intelligence on new technologies or treatment advances.
* Assists in developing independent medical education strategy (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 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.
* Assists in assuring the ongoing safety and adequacy of labeling of the Brand from a medical perspective.
* Assists in the interpretation of regulatory guidelines and directives to judge risk and causality.
* Assists the Sr. Medical Director in ensuring quality execution by collaborating closely with CTM and FMA in selection investigators/sites, ensuring screening and accuracy, and guiding interpretation..
* Assumes primary accountability as representative in Promotional Review Board (PRB) activities. This role requires full knowledge of product portfolio and understanding of various Federal and Pharma regulations and guidelines as well as in depth knowledge of disease state. REGULATORY & SAFETY ACTIVITIES: Supports the definition and implementation of the Brand’s labeling strategy.
* Assists the Sr. Medical Director in presenting clinical data at regional and national advisory boards. Leads assigned advisory boards
* Assists the Sr. Medical Director in providing medical input to the Brand’s market shaping strategy, marketing plans and promotional campaigns
* Participates in advisory boards, speaker training, Medical Marketing meetings, and other marketing activities as needed
* Participates in the development of medical product support and development plans for the Brand in concert with Sales and Marketing
* Supports ongoing sales and marketing objectives by assisting the Sr. Medical Director in making presentations as appropriate to external groups such as academic and community medical departments, professional associations, and P&T committees
* Works closely with Medical Information to assure that communication from Novo Nordisk is scientifically accurate and clinically appropriate
* Assist Sr. Director in collaboration with global publication planning team along with NNI Medical Operations.
* Assist the Sr. Medical 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 ISS strategy, including prioritization criteria, and support its execution.
* Assists Sr. Medical Director in providing NNI medical input on the product’s global clinical development plan.
* 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 Sr. Medical Director, build relationships and maintain a strong KOL network.
* Participate in Medical Marketing discussions regarding local and global clinical trials and assists with the preparation of Local Trial Proposal form as needed.
* Provide medical/scientific input into the Brand’s development and marketing strategies in consultation with the Sr. Medical Director.
* Provides content and ideas for publications run by Medical Operations.
* Reviews ISS proposals.
* 20-30% overnight travel required
* An M.D. or D.O. and 5 years’ experience, with clinical and prior direct patient care experience.
* Research or pharmaceutical industry experience in the relevant therapeutic area preferred.
* Strong strategic mindset, understanding of market needs, resource allocation, etc.
* Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools
* (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities,
* publications, ISS, med ed).
* Sub-specialty training in endocrinology and metabolism preferred.
Department CMR - MEDICAL AFFAIRS IN HOUSE MDS (2)
Position Location US - Plainsboro, NJ
State/Provinces US - NJ
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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Diabetes, Endocrinology, Healthcare, Law, Legal, Management, Manager, Medical, Patient Care, Pharmaceutical, Pharmaceutical Sales, Research, Sales, Science, Special Medicine