Senior Manager, Medical Affairs

Cosettepharma; Bridgewater, Northern (MA, KY); Hybrid; USD 159,000 - 199,000; Full time

Benefits offered by this job

Hybrid work schedule

Benefits package

Job summary

Cosette Pharmaceuticals, Inc. in Bridgewater, NJ, is seeking a Senior Manager, Medical Affairs to join a fast-growing branded portfolio. You will partner across medical, commercial, regulatory, and legal teams, translating medical strategy into compliant materials and coordinating education, CME, and congress activities.

The role emphasizes scientific exchange, KOL planning, and operational coordination across Medical Affairs workstreams in a hybrid environment.

Qualifications

• Advanced scientific or clinical degree required (PharmD, PhD, MD, DO, NP or PA).
• 7+ years of experience in pharmaceutical, biotechnology, medical device, healthcare, clinical research or related environments.
• Experience supporting Medical Affairs activities, scientific communications, MLR review, regulatory affairs or related functions.

Responsibilities

• Coordinate Medical Affairs plans and cross-functional deliverables across teams.
• Serve as medical reviewer for promotional and non-promotional materials with scientific accuracy.
• Support field medical readiness, engagement planning, and external scientific meetings.
• Assist CME, education initiatives, advisory boards, and congress planning.
• Track decisions, action items, timelines, and follow-ups to ensure timely execution.

Skills

interpret clinical data

medical communications

project management

cross-functional collaboration

attention to detail

FDA/regulatory knowledge

written communication

verbal communication

Education

PharmD/PhD/MD/DO/NP or PA

Job description

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 Summary

The 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 Responsibilities

Medical 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.

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.
• 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.

Medical Affairs Operations and Process Improvement

• 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.

Salary Range

The expected annual base salary for this New Jersey based position is $159,000 - $199,000. In addition, you may be eligible for a discretionary bonus if you are an active employee on the payment date.

Benefits

Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health saving account, employee assistance program, tuition reimbursement program, parental leave, wellness program, paid time off, volunteer time, and holidays.

Physical Requirements

This role will follow a hybrid work schedule, requiring three (3) onsite days per week at our Bridgewater, NJ office.