Director/Sr. Director, Medical and Scientific Writing (SSF, CA or Remote)
Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain, and eye. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.
Desired Candidate Profile
Director/Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Clinical Development Operations, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, Clinical, and Quality organizations to author and drive development of key documents in support of our gene therapy programs. This role will be responsible for the build of critical writing infrastructure and processes at Annexon (either via internal resource or strategic outsourcing), including the development of best practices and resources for document management and timelines, template, lexicon and document QC, publishing, and editing standards. You will also have an opportunity to support scientific communications, including contributions to the creation of manuscripts, abstracts and posters for congresses and external publication.
- Lead and direct all aspects of critical writing activities within Annexon, working cross-functionally to develop and produce high-quality deliverables such as clinical study protocols/amendments, IBs, CSRs, INDs/CTDs, safety updates and annual reports, narratives/summaries, briefing books, and additional 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.
- Participate on teams and assist to develop strategy and approach, ensuring consistency and efficiency with how messaging and documents are built and organized, contributing scientific knowledge and analytical skills.
- Build 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. You will collaborate closely with teams to develop realistic timelines to meet writing deliverables and program/corporate goals.
- As needed, collaborate with internal and external authors/vendors in support of the development of written deliverables, overseeing operational considerations and ensuring awareness of 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.
- Bachelor’s/Master’s degree or Ph.D./equivalent in a scientific discipline required.
- Relevant medical writing industry experience at a biotech or pharmaceutical company required, 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. 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 is a plus.
- Exceptional computer skills and familiarity with key software and cloud programs for document creation, sharing/editing, and data visualization preferred.
- A leader and role model who operates with an entrepreneurial spirit, integrity, independence, transparency, and exemplifies the Annexon core values with a focus on improving the lives of patients and families.
- Residence in the bay area preferred.
- Annexon’s Director/Sr. Director, Medical and Scientific Writing will be required to be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.