Associate Director, Medical Writing

Associate Director, Medical Writing

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases.  We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown.  Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven to improve the lives of patients.

Audentes leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues.  Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.

The Role

Reporting to the Senior 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) clinical summaries and overviews, CTD nonclinical summaries and overviews, clinical protocols, clinical study reports (CSRs), Investigator brochures (IBs), pediatric investigational plans (PIPs), and briefing documents for health authorities.

Responsibilities

  • Independently authors or oversees the writing of 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.
  • Maintains timelines and ensures smooth and effective document management from conception to final signature (ie, generation of a blank document to a final approved version), including oversight of various processes (eg, QC, editing)
  • 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.
  • Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area contributors as required and ensure adherence to standards
  • Leads or oversees document review and comment resolution meetings with cross-functional teams
  • Analyzes and interprets clinical study data
  • Performs literature-based research to support writing activities, as needed
  • Leads or participates in process improvement initiatives (eg, policies, forms, templates), including reviewing drafts produced by other writers.

Required Qualifications

  • BS degree with 8+ years' regulatory writing experience and expert knowledge of standard clinical regulatory document types, 2+ years' experience managing teams
  • Demonstrated success as the lead Medical Writer for regulatory submissions (IND, NDA, BLA, etc)
  • Strong document management and project management skills, along with initiative and ability to be productive with minimal supervision
  • Excellent verbal communication skills. Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management staff.
  • Knowledgeable about regulatory document requirements/guidelines with direct experience in a wide variety of regulatory document types
  • Proven experience in QC and editing of documents
  • Highly flexible and able to maneuver between different programs to ensure company objectives are met
  • Strong computer skills including MS Office (Word, Excel, Adobe)
  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Preferred Qualifications

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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
More details (document)
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