Job Description

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

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

Regulatory Collaboration

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

Vendor & Stakeholder Management

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

Process & Quality Improvement

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

Qualifications

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