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Director, Head of Medical Writing

Director, Head of Medical Writing

Job Title: Director, Head of Medical Writing
Contract Type: Permanent
Location: San Francisco, California
Industry:
Salary: Negotiable
Reference: MedWriterKM_1502812621
Contact Name: Kyle Murfin
Contact Email: k.murfin@sciproglobal.com
Job Published: August 15, 2017 16:57

Job Description

Director, Head of Medical Writing - San Francisco

The Head, Medical Writing leads the writing/manages the resources assigned to clinical, nonclinical, and regulatory documents according to applicable regulations. Clinical documents will include clinical study reports, regulatory briefing documents, and clinical sections of IND's, NDA's, and other regulatory submission documents. The Head of Medical Writing represents the Medical Writing function at key cross functional teams (e.g. Global Development Team, filing teams, Global Regulatory Team meetings) and works closely with the Regulatory Science staff as a key member of the Regulatory Science department.

Responsibilties:

  • Works with the Regulatory Science department to prepare other regulatory documents such as regulatory briefing packages, CTD summaries and overviews, and any other regulatory document required for submission.
  • Provides senior oversight of documents quality and consistency. Ensures efficient formatting of documents; ensures a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier and briefing package.

Qualifications:

  • 8-10 years of Medical Writing experience.
  • PhD or Masters of Science.
  • Strong Oncology background.

Director, Head of Medical Writing - San Francisco

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