- AbbVie (Worcester, MA)
- …connected, accurate, secure and in full compliance with AbbVie's global program and regulatory standards including FDA , EMA and MHRA requirements. This role ... inspections related to data integrity. + Ensure adherence to regulatory standards (e, g FDA , GxP etc.)...information management. + Must also be familiar with cGMP, Quality Systems, ALCOA+ principles, and other global regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …standard macros that can be adapted to multiple studies; Prepare deliverables for regulatory submission to FDA /EMA/PMDA or other agencies (eg eCRTs, ISS, ISE, ... the study, organize and prioritize programming activities including production and quality control of datasets and outputs while following internal standard… more
- Sanofi Group (Cambridge, MA)
- …legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA / regulatory issues and fraud and abuse) as well as proposed ... efficient prioritization of multiple requests, delegation as needed, and delivering high- quality service to business partners. Confidence working with senior leaders… more
- Philips (Cambridge, MA)
- …+ **Leads** the medical writing team in planning and delivering high- quality , compliant documents through effective resources, budget, and timeline management. + ... to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device...a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a… more
- Charles River Laboratories (Shrewsbury, MA)
- …In-life Operations, Formulations, Necropsy, Histology, Sample Processing, Clinical Pathology, Quality Control, Training and Archives. Responsible for the financial ... scientific staff for effective study design, problem solving, and delivery of high- quality study data. Foster a culture of continuous improvement in site operations… more
- Fujifilm (Boston, MA)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... vendor agreements, non-disclosure agreements, development, manufacturing and service agreements, quality agreements and clinical trial and research agreements, among… more
- State of Massachusetts (Boston, MA)
- …ELR Administrator and ensure appropriate ELR user access is granted per CLIA, DOJ, FDA , DHS or other regulatory authority including provision of ELR user support ... workflows, data analysis and result reporting, following CLIA, ISO17025, or other regulatory requirements of the MA SPHL. This position will oversee the electronic… more
- Integra LifeSciences (Braintree, MA)
- …and analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate ... years GMP/GLP laboratory experience in a medical device, pharmaceuticals, Quality / Regulatory Compliance, or other regulated industry +...or other regulated industry + Familiarity with application of FDA and/or ISO quality standards in a… more
- Abbott (Westford, MA)
- …high performing team. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... + Manufacturing experience with companies engaged in the manufacture of high quality , FDA regulated products. + Proven leadership skills, results oriented,… 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, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more