The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub team structure and serving as a member of the GRT. The Senior Manager will a

The Manager, Medical Reviewer provides operational oversight of medical materials review within the Medical Affairs function reporting to the Director of Global Medical Review. This individual works closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, Medical Affairs and Clinical Development to assure that all

The Executive Director QC leads a high functioning QC group comprising 35 40 individuals and 3 direct reports. The ideal candidate should be highly skilled in managing external manufacturing and testing sites both in the USA and across the world. The successful candidate will foster a collaborative environment and play a key role in developing and executing the strategy fo

The Sarepta Therapeutics QA Compliance Unit is seeking to fill a Full Time position for Manager, Quality Engineer to develop and maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies. Develop and maintain processes to facilitate QMS record completion through overseeing and enabling proper investigation including problem

The Real World Evidence (RWE) Contract Epidemiologist will provide leadership for scientific prospective and retrospective activities in the RWE team supporting Sarepta. The RWE Contract Epidemiologist will function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Qu

The Quality Control Analyst will work within the QC team, testing gene therapy products utilizing cell based assays (Potency assay) in support of clinical and commercial lot release and stability activities. These assays are conducted in house at the Sarepta facility in Andover, MA., with additional testing performed at contract testing laboratories (which may require peri

Sarepta Therapeutics is looking for an energetic and resourceful HR Informations Systems Technical Analyst. As an HRIS IT Technical Analyst, you will play a crucial role in supporting and optimizing our Human Resource Information System (HRIS), with a specific focus on Workday. Your expertise will be essential in ensuring smooth system operations, data integrity, and effec

The Scientist I, Bioinformatics works closely with several groups within Sarepta's Research and Development department. The Scientist I, Bioinformatics is part of the Genomics and Data Sciences team and plays a critical role in supporting Discovery Biology to advance our portfolio of RNA, gene therapy, and CRISPR based gene editing therapies to treat neuromuscular and CNS

The QC Data Manger will be responsible for overseeing review for accuracy and interpretation of data generated internally from testing laboratory charged with the execution of all GMP bioassay and Nucleic Acids Testing (release and stability) related to Sarepta's Gene Therapy pipeline. The Data Manager will be responsible for oversight and review of release and stability d

The Associate Director, Commercial Diagnostics & Bioinformatics reports into the Executive Director, Commercial Diagnostics and plays a key role in driving the strategic vision and objectives to make Sarepta a recognized leader in precision genetic medicine for rare diseases. The Associate Director, Commercial Diagnostics analyzes genetic diagnostic data to provide insight

This individual will work with cross functional teams to advance transformative precision genetic medicines for people with Duchenne muscular dystrophy (DMD). The ideal candidate must be able to lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands on innovative biostatistician. He/she will be a strategic thinker, a good commun

The Senior Director, Global Market Access Strategy (GMAX) drives market access strategy for Sarepta's assets with influential leadership that represent the goals and priorities of the broader International Business Unit to cross functional teams such as the Global Product Team (GPT) or Customer Org Sub Team (CT). This role is responsible for developing market access and ev

The Senior Manager will prepare and develop translational and clinical pharmacology plans including dose selections and predictions using mathematical and statistical models to study complex interactions between drugs, patients, and biological systems to understand disease progression and the impact of patient stratification on disease progression and pharmacology. This ro

The Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives. The role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufa

The Sr. Manager, GxP Training position is responsible to manage Sarepta's global GxP Training Program. The position will reside on site in the Andover, MA facility, reporting to the Director of Global Quality Systems. The position encompasses a variety of training management responsibilities, including maintaining a compliant GxP Training Program in accordance with US and