- Sumitomo Pharma (Boston, MA)
- …combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is ... preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan,… more
- J&J Family of Companies (Boston, MA)
- …in a fast-paced environment while managing multiple priorities. + Must not be debarred by FDA for work in any Medical Device business. + Must have a valid driver's ... license. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. + There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) + Employee may be required to lift objects up… more
- Tufts Medicine (Boston, MA)
- …and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines. 9. Identifies and resolves problems with protocol ... compliance by notifying investigator and as necessary with the protocol sponsor. 10. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. 11. Performs necessary tests as needed and as… more
- North Coast Seafoods (Boston, MA)
- …the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit + ... Ability to work in wet and dry conditions + Ability to work Monday-Friday, weekends when needed + Ability to use tools and equipment, including knives North Coast Seafoods is an equal opportunity employer and does not discriminate against otherwise qualified… more
- Pike Corporation (Mansfield, MA)
- …Verizon IDDS/ICGS drafting system. + Planning (establishment of feeder routes, FDA cabinet locations, distribution routes & boundaries.) + Design Engineering (feeder ... and distribution layouts to be redlined on base maps showing all requirements associated with OSP distribution). + CAD - ICGS Construction work print generation from IDDS/ICGS system. + Perform Self-check, Quality Control of own work for completeness,… more
- Edwards Lifesciences (Boston, MA)
- …and performance oversight. + Expertise in medical writing processes, regulatory requirements ( FDA , EU MDR), GCP, and ICH guidelines. + Advanced knowledge of ... biomedical statistics, clinical literature review, and therapeutic/product operations. + Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). + Exceptional problem-solving, analytical, and communication skills; ability… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …(Word, Excel, Visio, PowerPoint, etc.). + Familiarity with ISO-9000 + Familiarity with FDA QSR documentation requirements a plus. ZOLL is a fast-growing company that ... operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve… more
- Sanofi Group (Cambridge, MA)
- …in which pharmaceutical organizations function including but not limited to FDA , OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR). + Oversee conduct of all clinical studies in ... adherence to both Company standards, and government/industry regulations (GCP/ICH). + Review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s). + Partner with US Drug Safety in the management of clinical trial… more
- Bristol Myers Squibb (Devens, MA)
- …people management is required + Experience with Health Authority Audits (ie FDA ) is required **Minimum Requirements:** + Bachelor's degree required in Life Sciences, ... Supply Chain, or similar. + 7+ years relevant work experience required. + 3+ years of experience supporting ERP systems (preferably SAP). + An equivalent combination of education, experience and training may substitute. **BMSCART** **\#LI-ONSITE** **GPS_2025**… more
- North Coast Seafoods (Boston, MA)
- …the following motions: bending, twisting, squatting, and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit + ... Ability to work in wet and dry conditions + Ability to work Monday-Friday, weekends when needed + Ability to use tools and equipment, including knives North Coast Seafoods is an equal opportunity employer and does not discriminate against otherwise qualified… more