- 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
- Sanofi Group (Cambridge, MA)
- …supply management experience + Knowledge of pharmaceutical manufacturing quality systems and regulatory submissions process. + Knowledge of systems and tools ... lead, M&S & GBU Finance, Industrial Product Lead & Regulatory Affairs Our team is responsible for the End-to-End...set of products (safety stock, manage LCM timelines with Regulatory , target split between sourcing nodes, distribution network). +… more
- Deloitte (Boston, MA)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more
- Takeda Pharmaceuticals (Boston, MA)
- … authority requests (2 years); apply clinical trial methodology, various regulatory submissions , pharmacovigilance regulations, and safety profile to perform ... aspects of signal detection/safety review activities. + Draft responses to regulatory /ethics safety questions. + Close working relationship with physicians, both… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream ... processing. + Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay… more
- Astrix Technology (Boston, MA)
- …including RNA, genomic, proteomic, and imaging-based markers. + Contribute to global regulatory submissions (eg, INDs, CTAs) and provide medical input in ... Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs, to integrate and execute clinical strategy. + Represent… more
- IQVIA (Boston, MA)
- …issues as appropriate. * Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form ... and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on… more
- Point32Health (Canton, MA)
- …health care providers and institutions. Responsibilities include supporting provider negotiations, regulatory submissions , RFP/UDS submissions (as well as ... finding improvements) and ad hoc requests. The Senior Network & Provider Analytics Analyst may also serve as a project manager and/or lead cross functional teams for certain related projects. **Job Description** + Responsible for designing and generating… more
- Bristol Myers Squibb (Cambridge, MA)
- …pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier / submissions ; and assist in developing strategy ... safety and clinical pharmacology, Dev DMPK plays a critical role in IND submissions and marketing authorization applications. We utilize our deep expertise in ADME… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …all **pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions . You will conduct analysis, execution and reporting of ... + Author **pharmacometrics sections** of clinical pharmacology documents for regulatory filings including annual reports, investigator's brochure, IND/NDA applications… more
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