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:
Required Education, Skills and Experience
Preferred Education, Skills and Experience
|Posted on||11 Sep 2018|
Audentes Therapeutics (NASDAQ: BOLD) is a biotechnology company committed to the development and commercialization of innovative gene therapy products for patients living with serious, life-threatening rare diseases. We believe gene therapy technology has tremendous potential as a treatment approach for many genetic diseases. We are currently conducting Phase 1/2 clinical studies of our lead product candidates, AT132 for the treatment of X-linked Myotubular Myopathy (XLMTM), and AT342 for the treatment of Crigler-Najjar syndrome. We have two additional product candidates in development, including AT845 for the treatment of Pompe disease, and AT307 for the treatment of the CASQ2 subtype of catecholaminergic polymorphic ventricular tachycardia (CASQ2-CPVT). We are 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.