- Point32Health (MA)
- …health care providers and institutions. Responsibilities include supporting provider negotiations, regulatory submissions , RFP/UDS submissions (as well as ... Point32Health network. + Support RFP work including continuous improvements to the UDS submissions and create tools required to support quick turn arounds of RFPs. +… more
- Bristol Myers Squibb (Boston, MA)
- …on translational data generated to support asset development and contribute to regulatory submissions . This individual will work on cross-functional project ... written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize… more
- Philips (Cambridge, MA)
- …MDR, IEC 62304 and ISO 13485. Maintain comprehensive documentation to support regulatory submissions , audits, and compliance reviews. + Collaborate with global ... innovative, AI-powered medical software solutions that adhere to the highest regulatory and quality standards. **Your role:** + Lead clinical imaging software… more
- Takeda Pharmaceuticals (Boston, MA)
- …revise and/or update product labeling (ie CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions . Recommends scope, complexity and size, and influences the ... a disease area, taking into consideration the medical, scientific, regulatory , financial and commercial contexts worldwide; + leads multi-disciplinary,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …pre-IND, IND, phase1-3, **Pharmacokinetics** **(PK)** , **Pharmacokinetics-Pharmacodynamics (PK/PD)** and regulatory submissions . You will lead study design, ... integrate them into clinical development plans to support drug development and regulatory packages **.** + Lead **clinical pharmacology** activities related to study… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Health Authorities related to device clinical development + Prepare clinical sections for regulatory submissions (IDE, 510(k), PMA, IND, NDA, BLA) + Represent ... deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management:**… more
- Deloitte (Boston, MA)
- …Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years experience leading, ... like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory ...with CMC modules (Module 3 of CTD/eCTD) for global submissions , as well as familiarity with ICH guidelines (ie:… more
- Merck (Boston, MA)
- … Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple Therapeutic Areas, Regulatory Submissions **Job Posting End Date:** 08/2/2025 A job ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations + ... physician-scientists, clinical leads, clinical pharmacologists, BST, discovery research scientists, regulatory , non-clinical and other functions to build consensus for… more
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