Associate Director, Medical Writing

Green Key Resources; Massachusetts; On-site; USD 150,000 - 210,000; Full time

Job summary

BioPharma seeks an Associate Director of Medical Writing to provide strategic and operational leadership for medical writing across clinical programs. The role combines hands-on writing with resource planning and matrix leadership to deliver high-quality regulatory documents aligned with program goals.

The ideal candidate will have an advanced degree and 8+ years in medical writing or related areas, with experience supporting NDA/BLA/MAA and IND submissions, and a proven ability to manage

Qualifications

• Advanced degree in a relevant discipline.
• 8+ years of medical writing, clinical research, or related experience.
• Experience supporting NDA/BLA/MAA, IND submissions, and other major regulatory filings.
• Ability to lead complex projects, plan and optimize resources, and manage competing priorities.
• Strong ability to work independently, navigate ambiguity, and mitigate risk.
• Broad scientific understanding across multiple therapeutic areas; neuroscience experience preferred.
• Excellent written and verbal communication skills, with proven collaboration across teams.

Responsibilities

• Accountable for medical writing deliverables across one or more clinical programs, ensuring aligned timelines, quality, and resourcing.
• Independently author and lead planning, review, comment resolution, and delivery of routine and complex clinical and regulatory documents.
• Lead or coordinate clinical content development for complex regulatory submissions, aligning messaging with regulatory strategy.
• Serve as the primary medical writing lead on program teams, identifying risks and driving issue resolution.
• Oversee outsourced writing support, set expectations, manage review cycles, and ensure inspection-ready quality.
• Contribute to department goals, including process improvements and adoption of new tools and technologies.

Skills

Medical Writing

Regulatory Submissions

Cross-functional Leadership

Resource Planning

Program Management

Education

Advanced degree (PhD/PharmD)

Job description

Our rapidly growing BioPharma is looking for an Associate Director, Medical Writing to provide 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 Associate 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 Associate 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.
• 8+ years of relevant experience in medical writing, clinical research, or a related function;
• 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.