- J&J Family of Companies (Danvers, MA)
- …- 22 Cherry Hill Dr **Job Description:** Johnson & Johnson is currently seeking a ** Regulatory Affairs Co -op** to join our ** Regulatory Affairs ... and services while ensuring compliance with global regulations and internal procedures. The Regulatory Affairs Co -op will: + Assist in completing/documenting… more
- Bayer (Cambridge, MA)
- …**Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Biology, Molecular Biology, Medical Research, Regulatory Affairs , Compliance, Science, Healthcare, ... make a real difference, there's only one choice.** **Senior Director Global Regulatory Strategist, CGT** The Senior Director Global Regulatory Strategist, Cell… more
- Sumitomo Pharma (Boston, MA)
- …budget for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations , and Medical Affairs ... and liaises with Clinical (including Clinical Operations ), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and… more
- Sanofi Group (Cambridge, MA)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... scientific exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch… more
- Sanofi Group (Cambridge, MA)
- …scientific exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch ... **Job Title:** Global Medical Affairs Senior Director Kevzara **Grade:** L4-2 **Location** :...millions of patients around the world. **Main Responsibilities** + Co -develop, plan and lead the execution of the medical… more
- Organon & Co. (Boston, MA)
- …collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations , regulatory affairs , chemistry, manufacturing and ... 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical and/or… more
- Bristol Myers Squibb (Cambridge, MA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... personal lives. Read more: careers.bms.com/working-with-us . **Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** The selected candidate will… more
- Merck (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations ) + Provide clinical ... Medicine Operations , Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout sites… more
- Merck (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations ). + Provide clinical ... Operations , Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout research… more
- Merck (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations ). + Provide clinical ... Operations , Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout research… more
- Actalent (Cambridge, MA)
- …an understanding of Quality, Environmental, Health, & Safety (QEH&S) principles and regulatory affairs + Analyze batches of drug substances, intermediates, and ... HPLC, developing and validating new methods, and supporting manufacturing and regulatory needs through innovative analytical chemistry and methodology. We are… more
- Merck (Boston, MA)
- …matter expert within our Company, collaborating with project teams, biomarker leads, clinical operations , and regulatory affairs on the implementation of ... where relevant, DP) development teams for various assets/biomarkers (including Regulatory , Commercial, Business Development, Project Management, Operations ,… more
- J&J Family of Companies (Danvers, MA)
- …with a diverse team of Design Engineers, Development Engineers, Quality Engineers, Regulatory Affairs , Marketing, and Clinical + Provide quality engineering ... https://www.jnj.com **Job Function:** Career Programs **Job Sub** **Function:** Non-LDP Intern/ Co -Op **Job Category:** Career Program **All Job Posting Locations:**… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs , to develop and implement effective process ... including the development of scale down models for the study of unit operations , process safety evaluation as well as technical transfer to external contract… more
- Sanofi Group (Cambridge, MA)
- …Development & Launch teams, Regeneron alliance partners, Field Medical Leadership, Regulatory , Medical Affairs , Product Communications, and medical education ... + Understanding of market research, creative development and experience with regulatory review/approval process. + Ability to interact widely and effectively within… more
- Dana-Farber Cancer Institute (Boston, MA)
- …in developing project-oriented multi-disciplinary teams. + Interest or knowledge of regulatory affairs for sample-based and/or medical record review research ... projects and associated proposals and contributing to related budgets and regulatory IRB submissions + Responsible for submitting data requests both internally… more
- Beth Israel Lahey Health (Burlington, MA)
- …of Medicine. Participates in Root Cause Analyses of Sentinel Events. Works with the regulatory affairs team to ensure compliance with regulatory standards ... you're not just taking a job, you're making a difference in people's lives.** Associate Chief Medical Officer of Quality and Safety is a key leadership role for… more
- Sumitomo Pharma (Boston, MA)
- …medical alignment with the US Field Medical team, Medical Communications & Operations , Japan medical affairs colleagues, RWE (Real World Evidence) & ... Sumitomo Pharma Co ., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo… more
- Merck (Boston, MA)
- …objectives for field TA teams that are aligned with Global Medical and Scientific Affairs (GMSA) medical strategies + Co -chairs Regional Medical Affairs Team ... in alignment with Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO) + Coordinates with Global Scientific Affairs to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …Labeling at Global Regulatory Team (GRT) + Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead and Labeling Compliance to ... life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development… more