Director, Medical Writing

Role Summary

The Director, Medical Writing will lead document strategy, oversee authoring and review processes, and manage the creation of assigned regulatory documents. This role coordinates internal writers and external contract writer groups to produce high-quality preclinical, clinical, and regulatory submission documents in compliance with ICH/GCP and global health authority requirements. Location: Gaithersburg, MD; Radnor, PA.

Responsibilities

• Lead planning, authoring, and critical review of regulatory documents (e.g., Protocols, CSRs, IB, health authority briefing documents).
• Evaluate and review documents from internal and external writers to ensure consistency in objectives, formatting, nomenclature, and scientific approach across projects.
• Engage with external stakeholders such as vendors, thought leaders, or other groups as needed.
• Develop and manage timelines for authoring, review, and finalization of critical documents and related deliverables.
• Assess medical writing needs and ensure resources are available (in-house or via consultant/CRO support) for timely completion.
• Ensure smooth document management from template to final approved version, including first draft authoring, review coordination, bibliographies, and adherence to style guides.
• Support development, implementation, and improvement of best practices, document processes, and SOPs as needed.
• Develop and maintain templates/outlines for key documents and ensure adherence, with adjustments as appropriate per document.
• Lead matrix teams and drive high-quality preclinical, clinical development, regulatory, and scientific documents (including protocols, CSR, BLA/NDA/MAA CTD submissions, investigator brochures, briefing documents, and responses to regulatory questions).
• Demonstrate in-depth knowledge of drug/biologic development and GxP principles.
• Show strong leadership, planning, and project management with initiative and ability to work with minimal supervision.
• Coordinate and resolve comments with team members to finalize deliverables; facilitate comment resolution meetings as needed.
• Manage/prioritize multiple projects in a fast-paced environment; adapt to changing deadlines and priorities.
• Demonstrate strong written, verbal, and interpersonal communication skills; maintain high attention to detail; self-motivate and align efforts with corporate goals.
• Proficient in Microsoft Office and experienced with electronic document management systems; experience responding to company and regulatory audits.

Qualifications

• Required: Bachelor's degree in a scientific discipline; 8-12 years of experience in medical or scientific writing in the pharmaceutical or biotech industry for Bachelor's degree level.
• Preferred: Advanced degree (MS, Ph.D., PharmD, MD); 6-8 years of experience with advanced degree.

Skills

• Strong leadership, planning, and project management abilities.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to work collaboratively and coordinate team efforts to resolve comments and complete deliverables.
• Self-motivated, with the ability to self-manage and align with corporate goals.
• Proficiency in Microsoft Office; experience with electronic document management systems.
• Experience in responding to regulatory audits.

Education

• Bachelor’s degree in a scientific discipline; advanced degree desirable.