Director/Senior Director, Medical Writing

Work Location
Corporate Headquarters (South San Francisco, CA) - Hybrid
Position Summary
The Director/Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, 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 all of our Phase 1 through Phase 3 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.
Responsibilities

• 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. Also includes management of the department 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, 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.

Key Qualifications:

• 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.
• 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.

What Annexon offers

• Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit https://annexonbio.com/careers/
• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.

Company Summary
Annexon Biosciences is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.
EEO Employer - Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.
Staffing Agencies
Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon's website or Annexon Employees. Inquiries must be sent to talentacquisition@annexonbio.com with the Subject Heading: Staffing Agency Request.