Mar 14, 2019

Associate Director, Medical Writing

  • Audentes Therapeutics
  • San Francisco, CA, USA
Full time Media-Journalism

Job Description

The Role

Reporting to the Director, Medical Writing, the Associate Director, Medical Writing is responsible for developing and producing complex regulatory documents for global regulatory submissions, including Common Technical Document (CTD) nonclinical summaries and overviews, CTD clinical summaries and overviews, Investigator brochures, pediatric investigational plans (PIPs), clinical protocols, clinical study reports (CSRs), and briefing documents for health authorities.

Specific responsibilities include:

  • Independently authors a wide variety of regulatory documents such as CSRs, IBs, CTD summaries, PIPs, and regulatory responses according to regulatory requirements and internal Audentes document standards.
  • Works collaboratively with functional area contributors, ensuring all source information/data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines.
  • Provides thorough QC and editing of a variety of regulatory documents to ensure the production of high quality written deliverables
  • Leads or participates in process improvement initiatives. Reviews and contributes to draft initiative outputs (ie, policies, forms, templates) produced by other writers.

Required Education, Skills and Experience

  • BS degree with 8+ years' regulatory writing experience and expert knowledge of standard clinical regulatory document types, 2+ years' experience managing teams
  • Proven Experience in QC and editing of documents
  • Demonstrated success in leading the medical writing of regulatory submissions (IND, NDA, BLA etc).
  • Knowledgeable of regulatory document requirements/guidelines with direct experience in a wide variety of regulatory document types.
  • Well-developed computer skills including proficiency in Word, Adobe, Excel.
  • Excellent verbal communication skills. Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management staff.
  • Highly flexible and able to maneuver between different programs to ensure company objectives are met.

Preferred Education, Skills and Experience

  • Advanced degree
  • Experience in medical writing for gene therapy submission

Job Details

Reference # 2019B-107
Posted on 11 Sep 2018
Closes on  
Location(s) San Francisco
Department Regulatory
Career level Management
Hours/Status Full-time

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