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 by the goal of improving the lives of patients.
Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.
Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.
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.
- 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.
- Strong computer skills including MS Office (Word, Excel, Adobe)
- Commitment to Audentes values: Be BOLD, Care deeply, and#GetStuffDone
Preferred Education, Skills and Experience
- Advanced degree
- Experience in medical writing for gene therapy submission
|Posted on||11 Sep 2018|
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