Director, Medical Writing

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

Job Description

The Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands‑on writing expertise with responsibilities for resource planning and matrix leadership to deliver high-quality, fit‑for‑purpose clinical and regulatory documents aligned with program and regulatory objectives. The Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. The Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives.

Responsibilities

• Accountable for medical writing deliverables across one or more clinical programs, contributing to program-level plans and ensuring aligned timelines, quality, and resourcing.
• Independently author and lead the planning, review, comment resolution, and delivery of routine and complex clinical and regulatory documents.
• Lead or coordinate clinical content development for complex regulatory submissions, ensuring messaging alignment with regulatory strategy and development objectives.
• Serve as the primary medical writing lead on program teams, proactively identifying risks, anticipating cross‑functional challenges, and driving issue resolution.
• Oversee outsourced writing support, setting expectations, managing review cycles, and ensuring inspection‑ready quality.
• Contribute to the development and execution of Medical Writing departmental goals, including process improvements, inspection readiness initiatives, and adoption of new tools and technologies.

Qualifications

• Advanced degree (PhD, PharmD, or equivalent) in a relevant discipline.
• 10+ years of relevant experience in medical writing, clinical research, or a related function; 2+ years of people‑management or supervisory experience preferred.
• Experience supporting marketing authorization applications (NDA/BLA/MAA), IND submissions, and other major regulatory filings.
• Demonstrated ability to lead complex projects, plan and optimize resources (internal staff, vendors, and tools), and manage competing priorities.
• Strong ability to work independently, navigate ambiguity, and resolve complex, non‑routine problems through pragmatic risk mitigation.
• Broad scientific understanding across multiple therapeutic areas; neuroscience experience preferred but not required.
• Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams.

Employment Conditions

Alkermes has adopted a hybrid working environment: 60% of work time in the office and 40% from home, with the requirement to be onsite at our Waltham, MA office at least three days per week. This role is not eligible for fully remote work. Annual base salary ranges from $220,000 to $235,000, with eligibility for an annual performance pay bonus.

Equal Opportunity Employment

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E‑Verify employer.