Associate Director Medical Writing

Enigma Search; South San Francisco (CA); Presencial; USD 130 000 - 160 000; Tempo integral

Resumo da oferta

Enigma Search is looking for an Associate Director, Medical Writing in South San Francisco, California. This role involves leading the development of clinical and regulatory documentation, ensuring compliance with global standards, and managing the writing process. The ideal candidate will possess an advanced life sciences degree, with 8+ years in the field, strong communication skills, and the ability to collaborate effectively within teams. This position is vital for driving successful clinical program documentation and vendor coordination.

Qualificações

• 8+ years of medical or scientific writing experience.
• Deep familiarity with global regulatory requirements.
• Experience managing external vendors and/or contract writers.

Responsabilidades

• Lead medical writer for clinical programs.
• Author and oversee development of regulatory documents.
• Contribute to medical writing processes and quality improvement.

Conhecimentos

Medical or scientific writing

Project leadership

Collaboration across teams

Attention to detail

Strong organizational skills

Excellent written and verbal communication

Formação académica

Master’s degree in a life sciences field

PhD or PharmD preferred

Ferramentas

Microsoft Office

Adobe Acrobat

SharePoint

Veeva RIM

Descrição da oferta de emprego

About the job 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
• 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