Diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
Sr. Manager/Director, Medical Affairs position is a role with responsibility for Medical Affairs of surgical programs. This position reports to the head of medical affairs.
- Serve as medical liaison to R&D project teams for product design, validation, risk analysis and harm mitigation.
- Collaborate with internal (R&D) and external (KOL) stakeholders to design and execute post-approval studies to support commercial objectives.
- Drive scientific publications plan, including primary and co-authorship of manuscripts, posters and podium presentations.
- Serve as medical resource and reviewer for promotional and regulatory documents.
- Support materiovigilance and quality operations as subject matter expert in complaint investigation, health hazard evaluation, corrective and preventive action.
- Manage medical information requests through medical affairs call center systems, maintaining consultants’ roaster and serving as subject matter expert for majority of cases.
- Internal Customers/Business Partners:
- Research and Development
- Commercial Teams
- Regulatory Affairs
- Global Materiovigilance and Safety
- Quality Assurance
- External Customers/Business Partners:
- Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
- MD (US or foreign), ophthalmologist with at least 3 years surgical experience.
- Minimum 2 years experience in medical device (preferred) or pharmaceutical industry.
- Prefer prior exposure to medical device design and development.
- Excellent communication and interpersonal skills.
- Aptitude for learning quickly and working independently in fast-moving environment.
- Ability to create scientific presentations, as demonstrated through authorship in peer-reviewed journals or papers/posters at major congresses.
- Experience in creating strategically relevant materials for use by Medical Affairs and other relevant line functions.
- Ability to travel for both internal and external meetings (up to 50%).