Senior Director, Medical Writing

Annexon Biosciences; Brisbane (CA); Hybride; USD 257 000 - 286 000; Plein temps

Avantages offerts par ce poste

Shuttle service

Equity participation

Health benefits

Remote opportunities

Résumé du poste

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.

Responsabilités

• 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).

Connaissances

Scientific writing

Medical writing

Cross-functional collaboration

Project prioritization

Templates and standards

Formation

Bachelor/Master/PhD in science

Outils

Microsoft Office

Adobe Acrobat

SharePoint

GraphPad

Tableau

Spotfire

Description du poste

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.

Position

The Senior Director, Medical and Scientific Writing plays a critical role within 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 author and drive development of key documents in support of all of our programs.You will be empowered to interpret data, formulate messaging, and strategize on the development of Clinical and Regulatory documents.This role will be responsible for the building 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

• 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

Education, Experience, and Skills

Required

• 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.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.

Salary Range

$257,000 - $286,000 USD

Location

Annexon Biosciences is located in Brisbane, California This role operates under a hybrid work arrangement and requires regular onsite collaboration at our office. Candidates should be located within commuting distance and able to work in the office multiple days each week.

Benefits

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• 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, and other benefits.

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.