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)