- Catalent Pharma Solutions (Chelsea, MA)
- …relational databases and process automation protocols + Preferred experience working in FDA regulated operation in the pharmaceutical /biotech field + Physical ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent employee.** **The… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Skills: **Qualifications** + Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong ... procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, and correcting… more
- Cognizant (Boston, MA)
- …**_Qualifications_** 10+ years of experience in Testing & Validation within the pharmaceutical or life sciences domain, with a focus on digital transformation and ... processes Knowledge on ALM Test management tool Regulatory Knowledge: Strong understanding of FDA , EMA, GxP, and 21 CFR Part 11 requirements; experience with GAMP… more
- System One (Devens, MA)
- …PPE, including an air helmet. + Accurately complete batch records and documentation in compliance with FDA and cGMP guidelines. + Ensure all production and ... Production Technician to join a growing team at a pharmaceutical manufacturing facility in Devens, MA. This role is...2+ years' experience) + Strong understanding of GMP and FDA regulatory requirements + High level of safety awareness… more
- AbbVie (Worcester, MA)
- …to lead site analytics web and data quality initiatives within our pharmaceutical operation reporting into Digital Systems organization. This role is central to ... all data used in GxP systems are connected, accurate, secure and in full compliance with AbbVie's global program and regulatory standards including FDA , EMA and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in the ... the global regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory strategies defined within the GRT are… more
- Lundbeck (Springfield, MA)
- …access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. ** Pharmaceutical Environment/ Compliance ** - Apply knowledge of pharmaceutical ... environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and… more
- Beth Israel Lahey Health (Boston, MA)
- …of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including ... of adverse events and reports them according to the guidelines of the FDA , sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First"… more