Manager - Medical Promotional Review

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk 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 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?

 

The Position

Ensure scientific accuracy and clinical appropriateness and validity of promotional materials from a medical/scientific standpoint. Serve as a member of the Promotional Review Board (PRB). Additional responsibilities may include convention planning/staffing, sales training, product labeling committees and other projects as assigned.

 

Relationships

Reports to a Director level employee in Medical Information and works with stakeholders throughout NNI and at external agencies. Key relationships include Marketing, Legal, Regulatory Affairs, and Medical Affairs. Other relationships may include Convention Marketing and Sales Training.

 

The Manager may represent Medical on PRB working group, brand teams/extended brand teams, and product labeling committees.

 

Acts as a formal or informal mentor to others in Medical Promotional Review; may oversee PharmD Fellow(s) on a rotational basis.

 

Essential Functions

• Provide critical review of promotional pieces to ensure medical accuracy, validity and appropriateness of content in accordance with approved labeling, scientific data and relevant laws, regulations and NNI policies to support the safe and effective use of products by patients and the medical community
• Determine appropriateness of data and references used to support promotional claims and marketing messages and provide proactive recommendations and/or guidance for alternative data/references/language where needed
• Align and collaborate with key cross-functional stakeholders including other PRB reviewers and commercial team members on issues or concerns related to promotional materials or claims
• Engage with commercial business partners early in the development of promotional materials to enhance efficiency, when applicable
• Work with the Medical Director in Medical Affairs for the assigned product(s)/therapeutic area(s) to increase efficiency, medical alignment, and mitigate risk of promotional claims
• Review, provide comments and document verdicts for all assigned promotional materials within PRB workflow system based on assigned deadlines
• Participate in PRB meetings as assigned
• Remain current with medical literature and data in assigned therapeutic area(s)
• Participate in relevant internal and external meetings and trainings on new guidance/regulations, new scientific information and marketing strategy
• Participate in convention planning/staffing, sales training, product labeling committees and other projects as assigned
• May oversee the work of fellows, interns, or contingent workers working with the PRB Team

 

Physical Requirements

0-10% overnight travel required.

 

Qualifications

• Healthcare degree required; RN/NP/PharmD/PhD/MD preferred; 1 year of relevant experience required with an advanced healthcare degree or 3 years of experience required with a bachelor’s degree in h