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Cosette Pharmaceuticals, Inc.
Senior Manager, Medical Affairs
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What they do
A Medical Writer applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe the research results, product use, and other medical information. Medical writers may also offer writing support to the principal investigators for grant applications and specialized publications.
$109,084 / year median in New Jersey
+2% projected growth
Job Description
Senior Manager, Medical Affairs
Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.
Innovating every day.™Position SummaryThe Senior Manager, Medical Affairs reports to the Senior Medical Director and serves as a versatile, execution-oriented medical partner across several therapeutic areas within the company's fast growing branded portfolio. The role supports day-to-day Medical Affairs activities, including efficient medical/legal/regulatory review, field medical support, scientific exchange readiness, standard response letter creation, KOL management support, CME and educational initiatives, and operational coordination across Medical Affairs workstreams.
The position is designed for a scientifically strong, hands-on, entrepreneurial professional who is comfortable operating in a fast moving team environment, adapting as needs evolve, managing multiple tactical priorities across therapeutic areas, coordinating cross-functional deliverables, and helping translate medical strategy into compliant, high-quality materials that support commercial, field, and external education needs. The role will also support insight generation, KOL mapping and engagement planning, vendor coordination, training and congress and advisory board preparation.
Key ResponsibilitiesMedical Affairs Coordination and Cross-Functional Support
Innovating every day.™Position SummaryThe Senior Manager, Medical Affairs reports to the Senior Medical Director and serves as a versatile, execution-oriented medical partner across several therapeutic areas within the company's fast growing branded portfolio. The role supports day-to-day Medical Affairs activities, including efficient medical/legal/regulatory review, field medical support, scientific exchange readiness, standard response letter creation, KOL management support, CME and educational initiatives, and operational coordination across Medical Affairs workstreams.
The position is designed for a scientifically strong, hands-on, entrepreneurial professional who is comfortable operating in a fast moving team environment, adapting as needs evolve, managing multiple tactical priorities across therapeutic areas, coordinating cross-functional deliverables, and helping translate medical strategy into compliant, high-quality materials that support commercial, field, and external education needs. The role will also support insight generation, KOL mapping and engagement planning, vendor coordination, training and congress and advisory board preparation.
Key ResponsibilitiesMedical Affairs Coordination and Cross-Functional Support
- 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, Legal, and field teams on assigned projects.
- Coordinate 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.
- 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.
- 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.
- Support CME, independent medical education, and scientific education initiatives, including needs assessments, content review, logistics coordination, and outcomes follow-up.
- Assist with congress planning, advisory board preparation, medical booth support, scientific platform development, and speaker preparation in partnership with internal stakeholders and external vendors.
- Coordinate development of 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.
- Support 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. Qualifications Education
- Advanced scientific or clinical degree required (PharmD, PhD, MD, DO, NP or PA) Experience
- 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. Required Capabilities
- 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. Travel Requirements
- Approximately 10-20% travel, including medical congresses, advisory boards, internal meetings, and other business activities.