Lead Medical Writer, Oncology Regulatory Documents

1 month ago


Uxbridge, United Kingdom Gilead Sciences, Inc. Full time
Senior Manager, Medical Writing Oncology

About Gilead Sciences, Inc.

Gilead Sciences, Inc. is a biopharmaceutical company that aims to serve patients by leveraging its unique strengths and expertise.

Job Summary:

We are seeking an experienced Senior Manager, Medical Writing, Oncology to join our dynamic team. The successful candidate will have extensive experience in medical writing, regulatory documents, and oncology therapeutic area.

Key Responsibilities:

  • Author high-quality regulatory documents of various types and complexities, including clinical study reports (CSRs all phases), investigator's brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.
  • Represent Medical Writing on cross-functional teams, providing guidance for optimal presentation of data to achieve document intent.
  • Plan and oversee assigned medical writing deliverables, including development and management of document timelines and resource planning for assigned projects.
  • Serve as the filing lead for small to medium regulatory submissions.
  • Participate in process improvements, new standards, and updating document templates.
  • Cross-functionally collaborate with teams to advance product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas and in all markets around the world.

Requirements:

  • Bachelor's or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry.
  • Demonstrated ability to be a fast learner, flexible, and adaptable to change.
  • Recognized SME in a broad range of regulatory documentation and a resource for specialist advice and guidance.
  • In-depth knowledge of relevant health authorities, including systems, processes, and requirements.
  • Able to advise cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives.
  • Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills, and proficiencies with Microsoft Office suite.

Estimated Salary: $120,000 - $160,000 per annum, depending on experience and qualifications. We offer a comprehensive benefits package and opportunities for professional growth and development. If you are a motivated and experienced medical writer, please submit your application.



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