Sarepta Therapeutics Job Trends

The Sr. Manager, Corporate Quality – GCP, will provide program-level quality oversight and strategic support across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) compliance, ensuring that all clinical trial activities meet FDA regulations, ICH guidelines, and applicable international standards. As a core member of the Clinical Trial Team, the Sr. Manager will foster collaboration and deliver proactive QA guidance throughout the trial lifecycle. Responsibilities may include integration of acquired clinical programs into existing quality frameworks, vendor risk assessment and qualification, coordination and execution of investigator site...

The Associate Director, Labeling and Disclosures, will be responsible for leading global labeling activities for development and/or marketed products, and leading disclosure activities for applicable clinical trials. The Associate Director is responsible for the development, maintenance, and harmonization of core labeling (e.g., CCDS) and local labeling, ensuring compliance with applicable regulatory requirements while supporting business and lifecycle objectives. The Associate Director may also oversee the end-to-end operations for clinical trial registration, maintenance and results posting on Health Authority-managed databases worldwide (e.g., Clinicaltrials.gov, EudraCT). The Associate Director is responsible for effectively partnering and engaging with internal (e.g., cross-functional study teams, senior...