Manager - Medical Promotional Review

2+ years

Not Disclosed

Plainsboro

10 Nov. 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager, Medical Promotional Review

Location: [Location]
Company: Novo Nordisk

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. CMR plays a critical role in everything from developing regulatory strategies with the FDA to providing medical education and conducting data collection to support new product development. The department is driven by a shared commitment to a patient-centered approach, ensuring that the needs of patients guide every decision we make. At Novo Nordisk, you will be part of a team that is changing lives by improving the quality of life for patients worldwide. Ready to make a difference?

Position Overview:

The Manager, Medical Promotional Review is responsible for ensuring the scientific accuracy and clinical validity of promotional materials from a medical and scientific perspective. As part of the Promotional Review Board (PRB), the Manager will collaborate with cross-functional teams—including Marketing, Legal, Regulatory Affairs, and Medical Affairs—to ensure that promotional content is consistent with approved labeling, scientific evidence, and regulatory requirements. The Manager will also help drive strategic alignment and provide guidance on the appropriateness of promotional claims, supporting the safe and effective use of products. Additionally, the Manager will mentor and guide other team members, including PharmD Fellows and interns, on promotional review processes.

Key Responsibilities:

Review & Approval of Promotional Materials:
- Conduct detailed reviews of promotional materials to ensure medical accuracy and compliance with approved scientific data, labeling, and regulatory guidelines.
- Determine the appropriateness of data and references used to support marketing claims and provide recommendations for revisions or alternative data when needed.
- Collaborate closely with cross-functional teams, including PRB reviewers, marketing teams, and regulatory affairs, to resolve issues related to promotional materials.
Stakeholder Collaboration:
- Engage early with commercial business partners in the development of promotional materials to optimize efficiency and alignment with medical and regulatory requirements.
- Partner with the Medical Director in Medical Affairs for the assigned therapeutic area(s) to ensure consistency, medical alignment, and risk mitigation in promotional claims.
- Participate in PRB meetings, reviewing materials within the established PRB workflow system and ensuring timely completion.
Guidance & Training:
- Provide mentorship and oversight to fellows, interns, and contingent workers supporting the PRB team.
- Stay current with new medical literature, scientific data, and regulatory guidelines within assigned therapeutic areas.
Cross-Functional Engagement:
- Work with stakeholders in Convention Planning, Sales Training, and Product Labeling Committees to provide input on promotional activities and ensure regulatory and scientific alignment.
- Participate in internal and external meetings related to new marketing strategies, industry regulations, and promotional guidance.
Compliance & Continuous Learning:
- Ensure that all promotional materials comply with FDA regulations, ICH guidelines, and internal company policies.
- Keep up-to-date with emerging regulatory trends and best practices in the pharmaceutical industry, ensuring that promotional materials are in line with the latest medical and regulatory guidance.

Qualifications:

Education:
- A healthcare degree is required (e.g., RN, NP, PharmD, PhD, MD). An advanced healthcare degree is preferred, with at least 1 year of relevant experience in promotional review, clinical pharmacy, or a similar field, or 3 years of relevant experience with a bachelor’s degree in healthcare.
Experience:
- Knowledge of the US pharmaceutical industry, promotional review processes, and regulatory requirements.
- Prior experience in Novo Nordisk-supported disease states (e.g., diabetes, obesity, hemophilia, growth hormone disorders) is preferred.
- Familiarity with FDA regulations, GxP, and compliance requirements is essential.
Skills & Competencies:
- Strong editorial skills and keen attention to detail.
- Ability to work effectively in a cross-functional team and prioritize competing demands in a fast-paced environment.
- Strong communication skills, both verbal and written, with an ability to negotiate and influence.
- Excellent organizational skills, with the ability to handle multiple tasks and meet tight deadlines.

Working at Novo Nordisk:

Novo Nordisk is a global healthcare leader with more than 100 years of experience in tackling chronic diseases. We are committed to improving the lives of millions of patients around the world through our innovative treatments. With a workforce of over 63,000 employees worldwide, we believe in the power of collaboration, diverse perspectives, and fostering an inclusive culture. At Novo Nordisk, you’ll be part of a team working toward something bigger than yourself—a collective effort to change lives.

Application Deadline:

Applications are accepted until November 20th, 2024. Early application is encouraged as the position may close sooner depending on the volume of applications. Apply via our careers website.

Commitment to Inclusion:

At Novo Nordisk, we are committed to an inclusive recruitment process and provide equal opportunities to all applicants. We celebrate the diversity of our employees, the patients we serve, and the communities in which we operate. We encourage individuals from diverse backgrounds to apply.

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