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The Data Scientist, Research Sciences role at Sarepta is an exciting opportunity for someone with strong data science and analytical skills who wants to see their work directly impacting patient care. In this hands on role, the data scientist will research and develop advanced analytical methods to utilize internal and external chemistry and biological data to support all
Posted 1 day ago
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,
Posted 1 day ago
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
Posted 3 days ago
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 su
Posted 3 days ago
Career Level Technician Executes tasks autonomously, works with wide latitude for independent judgement and prioritization with minimal supervision. Minimal supervision with wide latitude for independent judgement. Intermediate problem solving responsibilities with guidance and assistance as needed to learn. Executes work independently or as part of a team. Trains lower le
Posted 4 days ago
The Director, Competitive Intelligence will manage the Customer organization's competitive intelligence function. This includes maintaining timelines, industry knowledge, market alerts, conference coverage, primary market research, and Leadership briefings on competitive events as they occur. This position partners with several functions throughout the organization to ensu
Posted 4 days ago
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
Posted 5 days ago
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
Posted 5 days ago
The QA Senior Associate is responsible for batch record review and disposition of clinical and commercial lots. The Senior Associate will be a key member of QA team in the assessment of CMO batch compliance with FDA and ICH regulations as well as internal procedures. This person will also be responsible for deviation and investigation review and closure and data entry. In
Posted 6 days ago
The person in this position will be working with a cross functional team as the project biostatistician responsible for statistical activities at the compound level or study level for one or more Gene therapy programs. It is an excellent opportunity to work at the forefront of precision genetic medicine, making an impact to the development of transformative therapies that
Posted 6 days ago
The Senior Manager, Supply Planning & Analytics will support various clinical and commercial programs and will be responsible for ensuring uninterrupted drug supply across the entire global drug supply manufacturing network. The candidate will work closely with Global Supply Chain, Manufacturing, Clinical Ops, Commercial, Quality, and third party vendors to ensure end to e
Posted 7 days ago
This individual will support analytical development activities conducted at Sarepta Andover facility in the field of in vitro potency of AAV based Drug products. The individual will help in the development and validation of cell based in vitro potency assays. The position requires a strong background in cell culture, sample preparation and protein analysis. The work involv
Posted 8 days ago
Sarepta is seeking an experienced psychometrician to join our Patient Centered Outcomes Research Team. As a psychometrician in this role, you will be instrumental in designing, developing, and validating patient reported outcomes measures and assessment tools to evaluate the impact of our portfolio of products on patients' outcomes. Your work will directly contribute to ou
Posted 8 days ago
Works as Global Regulatory Leads (GRLs). Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Represents Regulatory at the Global Development Team with relevant line function leaders. Develops and delivers on fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to supp
Posted 13 days ago
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. T
Posted 13 days ago
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