Medical Writing Strategy Lead | Associate Director

Green Key Resources; Boston (MA); In loco; USD 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Advanced degree

Medical writing

Regulatory submissions

Project leadership

Resource planning

Risk mitigation

Cross-functional collaboration

Communication skills

Formazione

PhD/PharmD or equivalent

Descrizione del lavoro

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