- Boston University (Boston, MA)
- …expenses for the CME Office. Operating within a highly regulated environment (eg. FDA , OIG, ACCME Standards for Commercial Support), the Financial Manager will work ... with other members of the CME team to ensure contract fulfillment and compliance, in addition to supporting the team with the financial aspects of their activities. The Financial Manager brings financial management acumen to the office and assists in the… more
- Fortrex (Woburn, MA)
- …450 plantas que limpia diariamente en norte America. Nosotros abarcamos USDA, FDA e instalaciones procesadoras de comida CFIA. Nuestros clientes trabajan fuertemente ... para perfeccionar sus productos y Fortrex se asegura de que esten protegidos. Fortrex es un empleador de igualdad de oportunidades. **LO QUE OFRECEMOS:** + Seguro Medico, Dental y Vision + Seguro de Vida Basico + Plan de Jubilacion 401K + Dias Festivos pagadas… more
- Teleflex (Chelmsford, MA)
- …GMPs and are auditable at all times. Assures compliance with GMP (ISO 13485, FDA 21 CFR 820, MDD 93/42EEC, and all applicable standards) * Lead discussion with ... line leaders and area employees to review production activity, operational issues, waste/scrap, and quality data to determine root cause, course of action to achieve goals, and potential process improvements. * Collaborate with pertinent departments and plant… more
- Eliassen Group (Boston, MA)
- …actions + Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components **Experience Requirements:** + Ability to ... manage competing priorities + Overall understanding of process instructions + Life Science Experience + Software Skills Required: MS Platform Suite, Oracle, Coupa + Functional knowledge of Engineering/Maintenance + Maximo or Asset Management EAM platforms… more
- Pfizer (Cambridge, MA)
- …Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Strong scientific writing skills and ... communication skills (written and verbal) + Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations. + Solid understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory,… more
- Astellas Pharma (Cambridge, MA)
- …one type of the following meetings: IND/IMPD, NDA/MAA, Advisory Committee or other PMDA/EMA/ FDA and preparing IND, IMPD, NDA, etc. + Strong business acumen and ... understanding of pharmaceutical industry regulations and processes (eg IND, NDA submissions). + Understanding of program management tools (eg, Microsoft Project, Smartsheet) and methodology. Knowledge and ability to improve project management tools and… 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 ... compounds. + Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment. + Proactive identification of challenges and development of… more
- Owens & Minor (Woburn, MA)
- …Training Program. + Must meet job-related requirements to comply with DOT, FDA and standards of accrediting body. **Language Skills** + English (reading, writing, ... verbal). **PHYSICAL DEMANDS** While performing the duties of this job, the employee uses his/her hands to finger, handle or feel objects, tools or controls; reach with hands and arms; stoop, kneel, or crouch; talk or hear. The employee uses computer and… more
- Owens & Minor (Springfield, MA)
- …Driver Training Program + Meet job-related requirements to comply with FDA and Joint Commissions regulations **SKILLS, KNOWLEDGE AND ABILITIES** + Patient ... Focused + Problem Solving/Analysis + Effective Communication + Integrity/Personal Credibility **Computer Skills** + Basic computer skills **Language Skills** + English (reading, writing, verbal) **Mathematical Skills** + Basic math skills **PHYSICAL DEMANDS**… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist, a typical day might include:** + Planning and driving all CSV activities required to maintain quality compliance as per existing Policies and Procedures for RCM. + Generating, carrying out, and… more