Senior Manager, Medical Affairs
Cosette Pharmaceuticals, Inc. · Bridgewater, NJ · 1 wk ago
On-siteHealthcare$159k–$199k/yrFull-time
Key Responsibilities
- Support execution of Medical Affairs plans.
- Translate Medical Affairs priorities into practical workplans, timelines, deliverables, and cross-functional follow-up.
- Serve as a responsive medical point of contact for Commercial, Market Access, Regulatory, and field teams on assigned projects.
- Cook up assigned Medical Affairs activities across promotional review, field support, educational programs, insights, training, and operational initiatives.
- Participate in the development and maintenance of core scientific resources, including scientific narratives, internal medical updates, evidence summaries, and product or therapeutic area reference materials.
- MLR Review and Medical Governance Support
- Serve as medical reviewer for promotional and non-promotional materials, ensuring scientific accuracy, fair balance, and alignment with approved labeling and substantiation.
- Maintain organized medical review documentation, reference libraries, claims grids, and review-ready support materials.
- Collaborate with Legal, Regulatory, Commercial, and external agencies to support review quality, reduce avoidable cycle-time delays, and maintain compliant ways of working.
- Field Medical and Scientific Engagement Support
- Support field medical readiness through scientific content preparation, field training, insight collection, and follow-up on scientific engagement needs.
- Participate in selected field engagements and external scientific meetings as appropriate to support compliant scientific exchange.
- Participate in KOL, HCP, and stakeholder engagement planning support, including mapping, profiling, segmentation, interaction planning, and compliant documentation of scientific exchange.
- CME, Education, and Scientific Communications Support
- CME, independent medical education, and scientific education initiatives, including needs assessments, content review, logistics coordination, and outcomes follow-up.
- Aid in congress planning, advisory board preparation, medical booth support, scientific platform development, and speaker preparation in partnership with internal stakeholders and external vendors.
- Cook up audience-appropriate medical communications materials, including slide decks, FAQs, training modules, standard response letters, and educational resources.
- Ensure educational activities are scientifically balanced, compliant, and aligned with Medical Affairs strategy.
- Medical Affairs Operations and Process Improvement Support
- Manage Medical Affairs operations, including project tracking, vendor coordination, meeting management, dashboards, routine reporting, and documentation of assigned workstreams.
- Track decisions, action items, timelines, and follow-ups from internal Medical Affairs meetings and assigned cross-functional initiatives to help ensure timely execution of priorities.
- Advanced scientific or clinical degree required (PharmD, PhD, MD, DO, NP or PA).
- 7+ years of experience within pharmaceutical, biotechnology, medical device, healthcare, clinical research, medical communications, or related environments.
- Experience supporting Medical Affairs activities, scientific communications, MLR review, clinical development, regulatory affairs, or related functions.
- Experience managing complex cross-functional projects and deliverables.
- Ability to interpret clinical data, medical literature, product labeling, treatment guidelines, and scientific evidence.
- Understanding of FDA-regulated pharmaceutical communications and compliant scientific exchange.
- Excellent written and verbal communication skills.
- Strong project management skills with ability to manage multiple priorities with an entrepreneurial mindset.
- Ability to collaborate effectively across Medical Affairs, Commercial, Legal, Regulatory, Market Access, and external partners.
- Strong attention to detail, scientific judgment, and execution discipline.