Executive Director, Medical Writing

About this role

Company:

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture!

Position:

The Executive Director, Medical and Scientific Writing provides strategic leadership and oversight of medical and scientific writing across the organization. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Clinical, Regulatory, Quality, Medical Affairs, Commercial and CMC departments to lead the strategy, authoring, and development of key documents in support of all of our programs. You will provide strategic direction in interpreting data, shaping scientific messaging, and overseeing the development of Clinical and Regulatory documents. This role will lead the development and ongoing optimization of critical writing infrastructure and processes at Annexon, including the development of best practices and resources for document management and timelines, template and shell creation, lexicon and document QC, publishing, and editing standards. You will also have an opportunity to support scientific communications, including the creation of manuscripts, abstracts and posters for congresses and external publication.

Responsibilities include:

• Provide strategic leadership and oversight of all critical writing activities within Annexon, working cross-functionally to develop and produce high-quality deliverables such as clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analysis and development plans, safety updates and annual reports, narratives/summaries, briefing books, and additional Research/Pre-Clinical/CMC, Clinical and Regulatory documents in support of our programs.

• In partnership with cross-functional teams, critically analyze and interpret non-clinical and clinical data (internal and external) to develop crucial strategy, conclusions, and messaging. As needed, perform literature and scientific database searches in support of analyses and development of background summaries.

• Serve as a senior strategic thought leader on cross-functional teams to develop strategy and approach, ensuring consistency and efficiency with how messaging and documents are built and organized, contributing scientific knowledge and analytical skills.

• Lead the development and evolution of a scalable medical and scientific writing infrastructure, with an emphasis on resourcing, that includes developing formats, templates, processes and standards, style guides, workflow, and operating procedures. Provide oversight of departmental resources and budget. You will collaborate closely with teams to develop realistic timelines to meet writing deliverables and program goals.

• As needed, collaborate with internal and external authors/vendors in support of the development of written deliverables, providing strategic oversight of operational considerations and ensuring alignment on expectations, milestones, and deliverables.

• Ensure that document content and style adhere to Annexon guidelines as well as ICH/FDA/EMEA or other appropriate requirements for compliance.

Education, Experience, and Skills:

Required:

• Bachelor’s/Master’s degree or Ph.D./equivalent in a scientific discipline with a minimum of 12 years of progressive scientific, medical, or technical writing experience, including demonstrated leadership of complex writing initiatives

• Prior work history at a biotech or pharmaceutical company preferred, smaller company environment ideal.

• A strong background and track record of leading the development of 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. Ability to think ahead and identify opportunities for change and improvement with an emphasis on operations and efficiency.

• Superior attention to detail and thoroughness related to processes, consistency, grammar, syntax, and scientific accuracy. Prior experience building a scientific and medical writing infrastructure and template repository is a plus.

• Exceptional computer skills and familiarity with key software and cloud programs for document creation (e.g.,…