- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational ... knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Strong scientific writing skills and communication… more
- Takeda Pharmaceuticals (Boston, MA)
- …and reporting to regulatory agencies. + Act as strategic partner to Clinical Program Quality for complex clinical deviations and Serious Breaches. + Review ... experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oversees and leads all clinical science activities involved in interactions with FDA , other regulatory agencies and key opinion leaders relevant to assigned ... empower you to shine? Join us as a Executive Medical Director, Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the pharmaceutical… more
- Sanofi Group (Cambridge, MA)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... **Job Title:** Clinical Outcome Assessment (COA) Lead **Grade:** L3 **Hiring...instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research… more
- Actalent (Cambridge, MA)
- …and/or other service providers. + Contribute to biostatistics, medical writing, safety, regulatory affairs , and quality assurance activities. + Interact closely ... Job Title: Associate Director, Clinical Operations Job Description Manage clinical trial activities for multiple trials, ensuring the timely completion of… more
- GE HealthCare (MA)
- …+ MD or equivalent medical degree required; + 10+ years in Pharmacovigilance, Medical Affairs and/or Regulatory Affairs in a Pharmaceutical company or CRO, ... of both marketed and investigational products. The ideal candidate will bring clinical expertise, regulatory awareness, and strategic insight to assess… more
- Edwards Lifesciences (Boston, MA)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic...with 5 years of related experience working in medical affairs , clinical affairs and/or … more
- Sanofi Group (Cambridge, MA)
- …Medical Affairs function serves as a key strategic partner with commercial, regulatory , clinical , HEVA and market access on therapeutic solutions to support ... the execution and support the strategy of global Medical Affairs studies, including the management of the study Steering... interactions and respond to request from the global regulatory agencies ( FDA , EMA and other agencies)… more
- Fresenius Medical Center (Lawrence, MA)
- …Capital equipment experience desirable + Strong collaboration skills and experience working with Clinical , Medical Affairs , and Regulatory teams. + Proven ... Marketing** , this individual works closely with cross-functional partners-including Clinical Education, Medical Affairs , Product Management, Patient Marketing,… more
- Sanofi Group (Cambridge, MA)
- …Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the ... The team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups,… more