Associate Director, Medical Writing Boston, MA, USA

Position Summary

The Associate Director, Medical Writing provides strategic, operational, and people leadership for a team or major body of work within Medical Writing. This role leads the development of clinical and regulatory documents that support global regulatory filings and coordinates the content of complex submissions, including document strategy, organization, messaging, timelines, and resourcing. The Associate Director applies advanced scientific and technical expertise to solve complex problems, strengthen cross-functional alignment, and ensure Medical Writing activities support broader development and regulatory objectives.

Key Responsibilities

• Independently authors routine and complex clinical and regulatory documents in support of development programs and regulatory filings
• Provides strategic input to program-level document plans, timelines, and submission objectives
• Demonstrates strong understanding of cross-functional roles and how they contribute to team and program success
• Aligns, coordinates, and drives consistent messaging across clinical programs and document deliverables
• Provides leadership for Medical Writing activities and directly manages a team
• Contributes to the development and execution of Medical Writing goals, processes, and departmental initiatives
• Supports implementation of new technologies, systems, and process improvements related to clinical document development
• Proactively identifies risks, resolves complex issues, and drives continuous improvement across document planning and execution

Knowledge and Skills

• Demonstrated ability to plan, manage, and optimize resources, including staff, vendors, and technology, to support business priorities and deliver high-quality outcomes
• Proven leadership, sound judgment, and ability to solve complex, non-routine problems across a broad range of scientific and operational issues
• Track record of anticipating risks, developing contingency plans, and driving timely issue resolution
• Broad understanding of scientific disciplines and drug development functions beyond primary area of expertise
• Experience managing direct reports and supporting employee development and performance management
• Experience supporting marketing authorization application submissions and other major regulatory filings

Experience and Qualifications

• Bachelor’s degree in a relevant scientific discipline; advanced degree preferred
• 5+ years of relevant experience in medical writing at a biotechnology and/or pharmaceutical company

Benefits

All eligible employees receive a generous package that includes: compensation, discretionary bonus, incentive stock options, the opportunity to participate in the Company’s health, dental, vision and 401k plans, life and disability insurance benefits, non‑accrual paid time off, company holidays and winter company shut down!

We embrace diversity and do not discriminate based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. Reasonable accommodations will be provided for individuals with disabilities during the application process, interviews, and while performing essential job functions. Contact Human Resources for accommodation requests.