Senior Director, Medical & Scientific Writing (Remote)

Annexon Biosciences; Brisbane (CA); Hybrid; USD 257,000 - 286,000; Full time

Benefits offered by this job

Shuttle service

Equity participation

Health benefits

Remote opportunities

Job summary

Annexon Biosciences is seeking a Senior Director of Medical and Scientific Writing to lead cross-functional development of key regulatory documents and manuscripts. You will shape writing standards, templates, and processes while aligning with ICH/FDA/EMEA requirements.

You will build a scalable infrastructure, manage budgets, and supervise internal and external writers to ensure timely, compliant deliverables across Clinical, Regulatory, Quality, Medical Affairs, and CMC programs.

Qualifications

• Bachelor’s/Master’s degree or Ph.D./equivalent in a scientific discipline with a minimum of 10 years of scientific, medical, or technical writing experience.
• Prior work history at a biotech or pharmaceutical company preferred, smaller company environment ideal.
• A strong background and track record of producing high quality scientific and medical documents for internal/external distribution.
• A strategic and flexible thinker who can translate complex data into clear, understandable, and compelling written summaries, interpretations, and positions for multiple audiences.
• Ability to work, communicate and collaborate with colleagues and external stakeholders as a team-player with transparency in a data-driven, fast-paced, and exciting environment.
• Capability and comfort with prioritizing multiple projects, deliverables, and timelines to exercise thoughtful judgment, problem-solving and decision-making.
• Superior attention to detail and thoroughness related to processes, consistency, grammar, syntax, and scientific accuracy.

Responsibilities

• Lead and direct all aspects of critical writing activities within Annexon, working cross-functionally to develop and produce high-quality deliverables such as protocols, IBs, CSRs, INDs/CTDs/amendments, analyses and development plans.
• Critically analyze and interpret non-clinical and clinical data to develop strategy, conclusions, and messaging; perform literature searches as needed.
• Participate on teams as a thought leader to develop strategy and ensure consistency in messaging and document structure.
• Build scalable writing infrastructure including formats, templates, processes, style guides, workflow, and SOPs; manage departmental budget.
• Collaborate with internal/external authors/vendors to support deliverables and manage milestones.
• Ensure content and style adhere to Annexon guidelines and regulatory requirements (ICH/FDA/EMEA).

Skills

Scientific writing

Medical writing

Cross-functional collaboration

Project prioritization

Templates and standards

Education

Bachelor/Master/PhD in science

Tools

Microsoft Office

Adobe Acrobat

SharePoint

GraphPad

Tableau

Spotfire

Job description

Annexon Biosciences is seeking a Senior Director of Medical and Scientific Writing to lead cross-functional development of key regulatory documents and manuscripts. You will shape writing standards, templates, and processes while aligning with ICH/FDA/EMEA requirements.

You will build a scalable infrastructure, manage budgets, and supervise internal and external writers to ensure timely, compliant deliverables across Clinical, Regulatory, Quality, Medical Affairs, and CMC programs.