Associate Director Medical Writing

Role Overview

We are seeking an Associate Director, Medical Writing to lead the development and execution of high-quality clinical and regulatory documentation. This individual will play a key role in shaping document strategy, managing the end-to-end writing process, and ensuring compliance with global regulatory standards.

The ideal candidate brings a combination of strong scientific expertise, project leadership, and the ability to collaborate effectively across internal teams, external partners, and vendors. This role requires both hands-on writing capabilities and the ability to guide complex, cross-functional initiatives.

Key Responsibilities

Clinical & Regulatory Writing Leadership

• Serve as the lead medical writer across one or more clinical programs
• Author and oversee the development of key clinical and regulatory documents, including:
  • Clinical study protocols and associated documents (e.g., informed consent forms)
  • Clinical study reports (CSRs)
  • Development Safety Update Reports (DSURs)
  • Investigator's Brochures (IBs)
  • IND summaries and overviews
  • CTD Module 2 clinical summaries
• Partner closely with Clinical Science and cross-functional teams to ensure alignment on document strategy and content

Regulatory Collaboration

• Work alongside Regulatory Affairs to support preparation of submission materials such as:
  • Health authority meeting requests and briefing documents
  • Responses to regulatory inquiries
  • Additional submission-related documentation as needed
• Ensure all deliverables meet global regulatory standards and timelines

Vendor & Stakeholder Management

• Provide direction and oversight to external medical writing vendors
• Manage priorities, timelines, and quality expectations for outsourced work
• Act as a central point of coordination across internal and external stakeholders

Process & Quality Improvement

• Contribute to the development and refinement of medical writing processes, templates, and style guidelines
• Partner with Quality Assurance to establish and update SOPs supporting medical writing activities
• Ensure compliance with ICH guidelines and other applicable regulatory frameworks

Qualifications

• Advanced degree in a life sciences field (Master's required; PhD or PharmD preferred)
• 8+ years of medical or scientific writing experience within biotech, pharmaceutical, or CRO environments
• Deep familiarity with global regulatory requirements (e.g., ICH, FDA, EMA, Health Canada, APAC guidelines)
• Demonstrated experience authoring a broad range of clinical and regulatory documents
• Experience supporting Investigator-Initiated Trials and collaborating with external investigators
• Proficiency with tools such as Microsoft Office, Adobe Acrobat, and document management/review platforms (e.g., SharePoint, Veeva RIM)
• Experience managing external vendors and/or contract writers
• Strong organizational skills and attention to detail
• Excellent written and verbal communication abilities
• Self-starter with the ability to operate in a fast-paced, evolving environment
• Comfortable working in a highly collaborative, hands-on setting