- Cardinal Health (Boston, MA)
- …plans for product development programs and regulatory submissions. **_Job Summary_** The Senior Regulatory Specialist , Data Management & Governance ... data meet these standards. + Manages the integrity of regulatory data used for regulatory submissions, clinical evaluations and post-market surveillance.… more
- Bausch + Lomb (Boston, MA)
- …of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across CMC and ... Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes. **Responsibilities:**… more
- Bausch + Lomb (Boston, MA)
- …reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management ... (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics). **Responsibilities:** + Interpret Regulatory Authority policies, regulations and guidances and correctly apply… more
- Beth Israel Lahey Health (Boston, MA)
- …matter and improvement methodology expert with internal data collection and regulatory software (Ottr/XynQAPI). + Senior -level expertise with data ... in people's lives.** Job Description Summary: The Heart Transplant Senior QAPI Program Specialist works to strengthen...by providing leadership and analytical support to the QAPI, regulatory , and data aspects of the BIDMC… more
- Bristol Myers Squibb (Devens, MA)
- …limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The ** Senior Specialist , Quality Assurance Shop Floor, Cell Therapy** position ... cGMP. In the capacity of QA Shop Floor, the Senior Specialist shall serve as one of...and represent function at cross functional meetings. + Share data /knowledge within and across team. Build & maintain strong… more
- Allied Universal (Boston, MA)
- …on the position and eligibility. **Job Description:** Allied Universal(R) is hiring a Senior Lead Client Assurance Security Specialist . The Senior Lead ... (CAS) role is a highly visible role supporting Global Security Leadership. The Senior Lead Client Assurance Security Specialist will evaluate processes to… more
- Bristol Myers Squibb (Devens, MA)
- …better place than here at BMS with our Cell Therapy team. The ** Senior Specialist , Associate Process Validation Engineer, Cell Therapy** provides process ... support to the Devens Cell Therapy Facility (CTF). The Senior Specialist participates in facility and process...Tech Transfers, and other Lifecycle Management changes. + Performs data analysis, including the use of statistics, and prepares… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated ** Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory ... validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part 11, GAMP...Part 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might… more
- Edwards Lifesciences (Boston, MA)
- …Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- GE Aerospace (Lynn, MA)
- …& Responsibilities: Consistent with the role of the ITC team, the primary tasks of Senior Specialist - ITC include, but are not necessarily limited to): + ... Manage and maintain records in accordance with US Government regulatory requirements and internal policies + Track, status, and...for the efficient and timely export of technology, technical data , hardware, and services + Serve as a Subject… more
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