- Takeda Pharmaceuticals (Boston, MA)
- …products (MES, ERP,MODA, LIMS). Knowledge management product (PLM, R&D Search). Drug and Device Management Lab Validation. + Structure and resource product ... with global regulations (eg, GxP, 21 CFR Part 11, FDA ) and Takeda's quality and risk management standards. +...in strategic governance forums, investment planning committees, and external regulatory or industry working groups as needed. + Ensures… more
- Takeda Pharmaceuticals (Boston, MA)
- …and data interpretation. + Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the ... Statistics function. + Advanced knowledge of FDA and ICH regulations and industry standards applicable to...applicable to the design, analysis of clinical trials and regulatory submissions. + Strong statistical programming skills + Excellent… more
- Sanofi Group (Cambridge, MA)
- …GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ ... ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could… more
- ThermoFisher Scientific (Plainville, MA)
- …facts; draw valid conclusions; and make decisions. + Detailed understanding of regulatory guidelines ( FDA , EMA, and other relevant authorities). + Excellent ... Serve ad subject matter expert on all downstream and drug product technology transfer activities. + Lead technology transfer...team; build and develop a team of downstream and drug product scientists and engineers to drive successful tech… more
- Pfizer (Cambridge, MA)
- …supply chain processes that fully comply with Industry regulations and quality standards ( FDA , GMP). + 5+ years of experience leading the design and architecture of ... caregiver/parental and medical leave, and health benefits to include medical, prescription drug , dental and vision coverage. Learn more at Pfizer Candidate Site -… more
- System One (Boston, MA)
- Title: Drug Clinical Research Coordinator Location: Boston MA Schedule: M-F (onsite daily) 8-5 Duration: 6 month contract to hire Pay Rate: $25-$30/hr Start: ASAP ... trial participants; Assist in maintaining accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... all other applicable laws, regulations, and standards. **Qualifications** + Bachelor's degree in related technical field or accredited NDT certification, or equivalent NDT work experience within the Oil and Gas industry. + Minimum 5 years' sales and customer… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... all other applicable laws, regulations, and standards. **Qualifications:** + High School Diploma or equivalent is required. + Bachelor's degree in business, marketing or related quantitative disciplines preferred. + Minimum of 2 years of field sales or… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... all other applicable laws, regulations, and standards. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill,… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience + 4+ years previous… more