Medical Writing Leader for Drug Development

4 weeks ago


San Francisco, California, United States Lifelancer Full time

Gilead Sciences Inc. is a leader in the fight against diseases such as HIV, viral hepatitis, COVID-19 and cancer.

We are seeking an experienced Medical Writer to join our team as Associate Director, Medical Writing.

The successful candidate will be responsible for authoring a wide range of regulatory documents independently, including novel or atypical documents which require ingenuity and considerable medical writing expertise and autonomy.

Key Responsibilities:

  • Document Authoring: Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs) (all phases), investigator's brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.
  • Cross-functional Collaboration: Represents Medical Writing and participates in multiple cross-functional teams, such as regulatory submissions and/or other regulatory project teams and provides guidance on regulatory submission document strategies.
  • Leadership: May serve as a filing lead for large complex regulatory submissions, with responsibilities including development and management of document timelines and resource planning for assigned projects.

Requirements:

  • Education & Experience: PharmD/PhD with 6+ years' relevant experience or equivalent.
  • Regulatory Knowledge: Recognized as a subject matter expert in a broad range of regulatory documentation and a resource for specialist advice and guidance.
  • Business Acumen: Demonstrates in-depth knowledge of current global and regional trends in medical writing and regulatory and is able to apply this to advance and accelerate medical writing strategies for assigned products or projects.

Benefits:

  • Estimated Salary: $177,905.00 - $230,230.00 per annum.
  • Bonus Scheme: Eligible employees may participate in a discretionary annual bonus scheme.
  • Stock Options: Eligible employees may receive stock-based long-term incentives.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We promote diversity and celebrate individual differences. Our environment respects individuality and recognizes each employee as an integral member of our company.



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