Associate Director, Medical Writing

Enigma Search; South San Francisco (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Enigma Search is looking for an Associate Director, Medical Writing, to oversee the development of clinical and regulatory documentation. The ideal candidate will have an advanced degree in life sciences and over 8 years of medical writing experience in biotech or pharmaceutical settings.

This role requires leadership in the medical writing process, collaboration with regulatory teams, and the ability to manage prioritization and quality of documents. Knowledge of global regulatory requirements is essential.

Qualifications

• 8+ years of medical or scientific writing experience in biotech or pharmaceutical environments.
• Proven track record of authoring clinical and regulatory documents.
• Strong familiarity with global regulatory guidelines like ICH and FDA.

Responsibilities

• Lead medical writing for clinical programs.
• Collaborate closely with Regulatory Affairs to prepare submission materials.
• Contribute to process improvements in medical writing.

Skills

Medical writing

Project leadership

Collaboration

Regulatory knowledge

Organizational skills

Communication

Education

Master's degree in life sciences

PhD or PharmD preferred

Tools

Microsoft Office

Adobe Acrobat

Document management platforms

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

• 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)
• 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
• 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