Senior Manager – Medical Review Lead
| Company | Moderna |
|---|---|
| Location | Cambridge, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | MBA, PharmD |
| Experience Level | Senior |
Requirements
- Advanced degree (PharmD, PhD) with scientific specialization in vaccines, infectious diseases, oncology, or related areas.
- Minimum of 5 years of relevant experience in the medical review of scientific, training or promotional content in a pharmaceutical or biotech setting.
- Working knowledge of global regulatory standards and promotional review requirements (e.g., FDA, EMA, OPDP, EFPIA).
- Ability to interpret complex data, summarize clinical evidence, and communicate scientific concepts effectively to diverse stakeholders.
- Demonstrated expertise in negotiating with legal, regulatory, and commercial stakeholders, effectively representing the organization’s interests while ensuring full compliance with all relevant laws and regulations.
- Strong attention to detail and a solutions-oriented mindset.
- Comfort working within structured review systems and in a cross-functional, matrixed environment.
Responsibilities
- Support the scientific review of promotional and non-promotional materials to verify data accuracy, proper substantiation, and consistency with clinical guidelines and scientific literature.
- Contribute content-specific insights to ensure external communications meet regulatory and scientific expectations while aligning with public health priorities.
- Participate in review meetings (MRC/PMRT), providing medical input on disease education, product communications, pipeline materials, and training documents.
- Collaborate with material owners and reviewers to clarify data interpretation and ensure alignment across therapeutic areas such as infectious disease and oncology.
- Assist in the implementation of established review processes and contribute feedback to continuously improve workflows and communication practices.
- Support peer training and documentation quality through your knowledge of scientific standards and regulatory frameworks.
Preferred Qualifications
- Ability to interpret complex clinical data and apply it to diverse scientific and promotional contexts.
- Experience and knowledge of FDA, EU, ICH guidelines and regulations.
- Demonstrated expertise in requirements for Medical Information Standard Response Letter Review.
- Highly developed skills in maintaining productive working relationships across multidisciplinary teams, even in high-pressure or conflict-prone scenarios.
- Proven ability to work independently in a matrixed environment and influence without oversight.
- Expert level of proficiency in Veeva Vault is a must.
- Strong background in leveraging artificial intelligence (AI) technologies in pharmaceutical or healthcare settings.
- Flexibility to support work beyond standard office hours, including occasional nights and weekends during congresses, product launches periods and urgent business needs.
- Excellent written and verbal communication skills; fluency in English required; additional languages a plus.
- Proficiency in digital technology and familiarity with virtual presentation platforms and Microsoft Office Suite.