- Sanofi Group (Cambridge, MA)
- …designing and executing clinical trials, analyzing trial data, interacting with regulatory agencies, and participating in internal decision making. CRD will work ... Research Scientist, Clinical Pharmacologist, Biomarker Lead, Safety Medical Director, Statistician, Regulatory and other key functional leads. The role requires a… more
- Astrix Technology (Boston, MA)
- …+ Compliance and Reporting: Ensure all activities comply with regulatory standards and company policies, and accurately document interactions and insights in ... join us! Our partners range from emerging biotech firms to established pharmaceutical companies, all seeking professionals who can bridge scientific insights with… more
- Cambrex High Point (Waltham, MA)
- …the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where organic chemistry underpins product ... reports, batch records, validation protocols, CMC documentation (eg, Module 3), and regulatory filings (IND, NDA). + Collaborate cross-functionally with QA, QC, … more
- Astellas Pharma (Cambridge, MA)
- …of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We ... and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance/Medical Safety in the development and maintenance of… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …This role is responsible for ensuring the robustness, scalability, and compliance of upstream operations through effective technology transfer, validation support, ... and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. +… more
- Sanofi Group (Cambridge, MA)
- …Manufacturing and Supply network (eg procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition ... LM GenMed. This individual provides strategic leadership, direction, and oversight for compliance and risk management programs and is responsible for fostering a… more
- AbbVie (Worcester, MA)
- …next manager to ensure departmental activities are planned and executed safely. + Compliance : Ensure compliance with applicable regulatory agencies. Execute ... and facilitate safe operations in line with all safety, regulatory and operational requirements. Assure the delivery of high...floor promoting a culture of zero safety incidents in compliance with all EHS requirements. + People: Responsible for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and operationalize strategies and tactical plans. + Thorough understanding of legal, compliance , and regulatory guidelines related to medical affairs in the ... Other advanced degreed professionals considered depending on past relevant pharmaceutical industry experience, and/or clinical work, research, or academic endeavors… more
- Takeda Pharmaceuticals (Boston, MA)
- …Risk Management Scientist/Associate Director. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a ... + Engages with partner global functions (eg Clinical Science, Med Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance… more
- Guidehouse (Boston, MA)
- …all levels, to deliver product planning, pricing, reimbursement, product commercialization, and regulatory and compliance solutions. Do you think you are up ... Guidehouse's Life Sciences practice is an engine of innovation, helping pharmaceutical , biotech, medical device, and diagnostic companies develop custom solutions… more