Director, Medical Writing & Regulatory Strategy

Alkermes; Boston (MA); Hybrid; USD 220,000 - 235,000; Full time

Benefits offered by this job

Performance pay bonus

Job summary

Alkermes, located in Waltham, MA, seeks a Director of Medical Writing to provide strategic leadership in medical writing across clinical programs. This role involves hands-on writing and management of medical writing deliverables, ensuring quality and compliance with regulatory submissions.

The ideal candidate will bring over 10 years of experience in medical writing, with a preference for those with supervisory experience. The position maintains a hybrid work environment requiring onsite presence three days per week. The role offers a salary range of $220,000 to $235,000 plus potential performance bonuses.

Qualifications

• 10+ years in medical writing or clinical research, including 2+ years in people management or supervisory roles.
• Experience in marketing authorization applications (NDA/BLA/MAA) and IND submissions.

Responsibilities

• Lead planning, review, and delivery of clinical and regulatory documents.
• Manage outsourced writing support and ensure inspection-ready quality.
• Identify project risks and drive issue resolution.

Skills

Medical writing expertise

Project management

Regulatory submission experience

Cross-functional collaboration

Education

PhD, PharmD, or equivalent in a relevant discipline

Job description

Alkermes, located in Waltham, MA, seeks a Director of Medical Writing to provide strategic leadership in medical writing across clinical programs. This role involves hands-on writing and management of medical writing deliverables, ensuring quality and compliance with regulatory submissions.

The ideal candidate will bring over 10 years of experience in medical writing, with a preference for those with supervisory experience. The position maintains a hybrid work environment requiring onsite presence three days per week. The role offers a salary range of $220,000 to $235,000 plus potential performance bonuses.