Director, Medical Writing - Permanent - California, Foster City
Proclinical is seeking a Director of Medical Writing for an opportunity based in Foster City, California. This role offers a relocation package for candidates not local to the San Francisco area.
Primary Responsibilities:
As the Director of Medical Writing, you will lead the development of high-quality, strategically aligned medical writing deliverables that support regulatory requirements for clinical development programs. You will collaborate with cross-functional teams to ensure accuracy, compliance, and alignment with US and international regulatory standards.
Skills & Requirements:
- Strong writing skills with a solid understanding of the drug development process and regulatory guidelines.
- Proven ability to write and edit complex material for clarity, accuracy, and consistency. Experience managing complex clinical-regulatory writing projects across multiple therapeutic areas.
- Excellent attention to detail, multitasking, and prioritization skills.
- Strong communication skills and ability to work effectively in a cross-functional environment.
- Familiarity with US and European regulatory requirements, including eCTD structure, format, and content.
- Ability to critically analyze and synthesize complex scientific information.
- Proficiency in MS Office applications, Adobe Acrobat, and electronic document management systems (e.g., Veeva Vault, Box, SharePoint).
- Comfortable working in a fast-paced environment with minimal direction and adaptable to changing priorities.
- Demonstrated initiative and ability to manage multiple projects simultaneously.
- Strategic thinking and leadership skills, even without formal authority.
Preferred Education and Experience:
- Bachelor's degree in a scientific field required; advanced degree (PhD, PharmD, or MS) preferred.
- Significant experience in regulatory medical writing within the pharmaceutical industry, including team management and authorship of key clinical-regulatory documents.
- Knowledge of endocrinology, oncology, neurology, and/or metabolic diseases is preferred.
The Director, Medical Writing's responsibilities will be:
- Serve as the medical writing subject matter expert on strategic project teams, advising on content, format, and style requirements for documents.
- Manage in-house medical writing staff, vendors, and contractors, providing guidance on prioritization, timelines, and process management.
- Mentor and support team members in skill and career development.
- Author, co-author, edit, and format clinical-regulatory documents, including NDAs, protocols, protocol amendments, CSRs, Investigator Brochures, and other regulatory submissions.
- Collaborate with contributors and reviewers to manage expectations, resolve issues, and ensure alignment on document timelines and content.
- Lead the development and refinement of medical writing processes, SOPs, templates, and quality control measures to ensure efficient preparation of deliverables.
- Maintain expertise in the company's investigational products, disease indications, and relevant regulatory and publication guidelines.
- Perform additional duties as needed to support the team and organizational goals.
Compensation:
- $220 000.00 - $250 000.00 Per Annum
If you are having difficulty in applying or if you have any questions, please contact George Watson at g.watson@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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