Associate Director, Medical Writing

Green Key Resources; Boston (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

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

Accountable for strategy, planning, and execution of submissions; partners with Clinical Development, Regulatory Affairs, Biostatistics, and other functions to ensure cohesive

Qualifications

• Advanced degree required (PhD, PharmD, or equivalent).
• Experience leading medical writing for clinical and regulatory documents.
• Experience supporting NDA/BLA/MAA, IND submissions, and other regulatory filings.
• Ability to lead complex projects, plan resources, and manage competing priorities.
• Independent work style with ability to navigate ambiguity and mitigate risk.
• Broad scientific understanding across therapies; neuroscience experience preferred.
• Excellent written and verbal communication across diverse teams.

Responsibilities

• Accountable for medical writing deliverables across one or more clinical programs, ensuring timelines and resourcing.
• Independently author and lead planning, reviews, and delivery of routine and complex documents.
• Lead or coordinate clinical content development for complex regulatory submissions.
• Serve as primary medical writing lead on program teams, identifying risks and driving resolutions.
• Oversee outsourced writing support, manage reviews, and ensure inspection readiness.
• Contribute to departmental goals, including process improvements and tool adoption.

Skills

Advanced degree

Medical writing

Regulatory submissions

Project leadership

Resource planning

Risk mitigation

Cross-functional collaboration

Communication skills

Education

PhD/PharmD or equivalent

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 judgement 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 optimise 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.