The Associate Director of Quality Control Nucleic Acids Testing will be responsible for overseeing a laboratory charged with the execution of all GMP Nucleic Acids Tests (release and stability) related to Sarepta's Gene Therapy pipeline. The Associate Director will build and oversee a team of four to eight QC technicians with testing responsibilities that include a variety

The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline. The Associate Director will build and oversee a team of eight to ten QC technicians with responsibilities that include but are not limited to

The Associate Director, Patient Affairs creates and maintains strong relationships with the patient community and patient advocacy groups in the neuromuscular space to enhance the individualized approach to patient care that defines Sarepta's commitment to our patient communities. This position reports to the Senior Director, Patient Affairs to lead our collaborations with

Serves as a stat programming expert or point of contact for assigned clinical studies under close/limited supervision of the stat programming project lead Primary Responsibilities Include Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers CDISC and regulatory compliant SDTM,

Lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the primary interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs). Positively contributes to the global regulatory strategy for clinical and c

The Sr. Manager reports to and serves as a strategic partner to the Executive Director, Head of Global Field Medical Strategy & Launch Execution ("Executive Director"). The supported function includes Sarepta's HCP focused field medical teams (US and global) and medical launch execution. The position works closely with the Executive Director to establish the function's str

The Senior Manager, Capital Projects operates within the Real Estate, Facilities and Engineering department. This position develops facility projects (lab, office and Current Good Manufacturing Practice (cGMP) Manufacturing), both renovation and new construction, to support the Sarepta Capital Improvement Program, from initiation stage through planning, design and construc

The Real World Evidence (RWE) Analytics Contractor supports scientific prospective and retrospective activities for the RWE team at Sarepta, and will be responsible for providing hands on analytic expertise and technical guidance on project teams. This individual will participate in the design, development, and quality control process for SAS programs used to access, extra