Co-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs) for assigned projects. Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Develops and delive...
The Manager, Trade and Distribution Operations is a field-based role with a focus on assisting in the management of trade operations as well as overseeing trade relations data and information across all trade channels including 3PL, Specialty Distributor, Specialty Pharmacies, and other key trade accounts. This position is responsible for implementing and managing the day-to-day operations of Sarepta's Trade and Distribution channel for our exist...
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 effective integration with other software and modules. You’ll collaborate closel...
The Patient Service Specialist II supports Duchenne Muscular Dystrophy patients and families as a member of the Patient Services Team. Paired with a Case Manger(s), the Patient Service Specialist II supports the team through data updates to patient records, tracking case status, set-up of new patient referrals and patient outreach. The Patient Service Specialist II will learn and master all skills of Case Management. Primary Responsibilities Incl...
This individual will be a member of the local quality team that supports preclinical and clinical gene therapy research functions. This individual will be responsible for assisting with the maintenance of the local archives, electronic, paper, and other records. Primary Responsibilities Include. Assist with organizing, tracking, correcting, filing, and cataloging records. Assist with generating and updating tracking spreadsheets for various recor...
We are seeking a hands-on team player who enjoys collaborating with colleagues and shares a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. The candidate in this role will be supporting method transfer from the analytical development group and the establishment of cell-based assays in the process analytics laboratory. Technical proficiency in analytical methodologies (cell-based assays, qPCR, ...
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 construction. This position manages and coordinates the activities of an assigned p...
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 for managing high throughput clinical and commercial QC testing programs to e...
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, Quality Assurance, Manufacturing, Commercial, Market Access, Medical, Researc...
The MSL will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenne Muscular Dystrophy and Limb Girdle Muscular Dystrophy as well as Sarepta's investigational therapeutics and product pipeline. Reporting to the West Region Team Leader, the MSL position will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenne Muscular Dystrophy and Limb Girdle Muscular Dystrophy as well as Sarepta'...
The Director of IT Portfolio & Project Management Office will be responsible for the successful delivery of all IT projects and programs, and management of the IT project portfolios. This includes working with project managers and IT teams to execute projects, manage project financials and align deliveries to expected business outcomes. This is a hands-on job for a detail-oriented leader who is passionate about portfolio project management, comfo...
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 evidence generation strategies, communicating the vision and mission of the f...
