Senior Medical Writing Manager
6 days ago
As a Senior Medical Writing Manager at Gilead Sciences, Inc., you will play a crucial role in advancing the company's product strategies and ensuring successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies.
The ideal candidate will have significant medical writing experience in the biopharma industry, with a strong background in regulatory documentation and a proven track record of authoring high-quality documents.
You will be responsible for leading review and planning processes for multiple products or projects, representing Medical Writing on relevant product, project, and/or regulatory submissions teams, and providing specialist guidance on optimal content and presentation to achieve product/project objectives.
Key Responsibilities:
- Author a wide variety of documents of all types and complexities, including clinical study reports (CSRs), investigator's brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.
- Represent Medical Writing in cross-functional teams, providing guidance for optimal presentation of data to achieve document intent.
- Plan and oversee assigned medical writing deliverables, developing and managing document timelines and resource planning for assigned projects.
- Serve as the filing lead for small to medium regulatory submissions.
- Participate in development/improvement of document standards, templates, and processes.
Requirements:
- Bachelor's or advanced degree in life sciences or related field.
- Significant medical writing experience in the biopharma industry.
- In-depth knowledge of relevant health authorities and regulatory document requirements.
- Strong analytical thinking skills, attention-to-detail, and communication and writing skills.
- Able to lead and influence programs, projects, and initiatives.
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