Sr. Manager – Medical Affairs Operations
Company | Moderna |
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Location | Cambridge, MA, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | Bachelor’s, Master’s |
Experience Level | Senior |
Requirements
- Bachelor’s degree in a relevant field (e.g., life sciences, public health, business).
- 5+ years of operational experience in medical affairs, clinical operations, or project management within the pharmaceutical or biotechnology industry
- Strong operational knowledge of medical affairs processes, including scientific communications, publications, and regulatory compliance.
- Proven experience managing complex operational projects and coordinating cross-functional teams.
- Strong organizational and problem-solving skills with attention to detail.
- Excellent communication skills, both written and verbal.
- Familiarity with regulatory and compliance guidelines (e.g., FDA, EMA, GDPR).
Responsibilities
- Lead the operational planning and day-to-day execution of key initiatives for the US Medical Affairs team, ensuring effective alignment with global medical operations.
- Serve as the primary liaison between the US affiliate and Global Medical Affairs Operations to coordinate processes, reporting, and communications.
- Develop, implement, and manage efficient workflows and procedures to support scientific communication, medical education, and real-world evidence generation.
- Oversee budget management and tracking, resource allocation, and vendor management for US Medical Affairs projects.
- Support the development and maintenance of systems and tools for medical information management, including content creation, approval processes, and distribution.
- Collaborate with Global Medical Affairs to ensure consistent reporting, metrics tracking, and analysis of medical activities across regions.
- Lead continuous improvement efforts in Medical Affairs operations by optimizing processes, solving operational challenges, and implementing best practices.
- Ensure compliance with regulatory, legal, and ethical guidelines in all US Medical Affairs activities.
- Provide project management support for key initiatives, ensuring timely execution and effective resource utilization.
- Partner with cross-functional teams (commercial, clinical, regulatory, etc.) to support product launches and lifecycle management activities.
- Support Medical Affairs teams with data analysis, publication planning, and advisory board logistics as needed.
Preferred Qualifications
- Advanced degree in a relevant field (e.g., life sciences, public health, business).
- Experience working in global organizations with cross-functional and cross-regional collaboration.
- Proficiency in medical information management systems and project management tools.
- Demonstrated ability to drive process improvements and implement best practices in medical affairs operations.
- Knowledge of product launch and lifecycle management in the biopharmaceutical industry.
- Vendor management experience related to medical affairs projects.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.