Annexon Biosciences is a clinical-stage biopharmaceutical company pioneering the development of a new class of medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders. The company’s pipeline is based on its platform technologies addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway. Annexon is deploying a disciplined, unbiased biomarker-driven strategy designed to improve the probability of technical success of its portfolio and striving to deliver precision medicine to patients with classical complement driven diseases in the body, brain and eye.
Desired Candidate Profile
The 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. You will be empowered to interpret data, formulate messaging, and strategize on the development of Clinical and Regulatory documents and designations. Likewise, you will synthesize Non-Clinical/CMC and Clinical data into summaries and reports and will be able to develop key content and messaging about our data and novel platforms. This role will be responsible for the build 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.
- 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, 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.
- Participate on teams as a key thought leader 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 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 with 5+ 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, ideally with prior gene therapy or stem cell biology experience and education.
- 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., Microsoft Office, Adobe, etc.) sharing/editing (e.g., Sharepoint, Graphpad, Tableau, etc.), and data visualization (e.g., Spotfire, etc.).
- 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.
Annexon Bio is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Employment is conditioned upon full vaccination 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.
Recruitment & Staffing Agencies: Annexon Bio does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Annexon Bio or its employees is strictly prohibited unless contacted directly by the HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Annexon Bio, and Annexon Bio will not owe any referral or other fees with respect thereto.