- Novo Nordisk (Lexington, MA)
- …before, during and after inspections, working with stakeholders across multiple functions. The Associate Director , CQ, R&D Quality- will also act as the Clinical ... for patients. Do you dream of using your solid GCP knowledge, process optimisation skills and quality mind-set in...a member of our team and serve as an Associate Directors for Clinical Compliance, Research & Development (R&D)… more
- Kelly Services (Burlington, MA)
- **Sr. Manager/ Associate Director - Quality Assurance** **Burlington, MA** **Direct Hire** **Compensation: $125k-165k base + 10-15% annual bonus** **Candidate ... growth of the Quality function. This individual will report to the Sr. Director of Global GCP /GLP compliance and while working closely with the US Site VP and… more
- Merck (Boston, MA)
- …will include developing and maintaining a profound understanding of Good Clinical Practice ( GCP ) with respect to digital data management (ie use of novel technology ... for maintaining current regulatory inspection knowledge as it relates to GCP inspections by regulatory agencies worldwide, especially those conducted by key… more
- Frontier Medicines (Boston, MA)
- Join us as the Senior Manager/ Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP ... standards, including but not limited to: US CFR, EU CTD, and ICH GCP + Familiarity with electronic document management systems and computer system validation +… more
- Bristol Myers Squibb (Boston, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Summary** The Regional Associate Director (RAD) role is field-based and focused on ... those that are specific to the role of FM + Understands PhRMA Code, ICH, GCP , and relevant FDA laws and regulations + Completes and certifies understanding of all… more
- Novo Nordisk (Lexington, MA)
- …to develop new medicines for patients. The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in ... trial operations, in multiple phases of research + Strong knowledge of ICH guidelines, GCP and FDA regulations + Experience with all aspects of trial and site… more
- Bristol Myers Squibb (Cambridge, MA)
- …clinical science, clinical research, or equivalent + Proficient knowledge of GCP /ICH, drug development process, study design, statistics, clinical operations + ... Proficient knowledge and skills to support program specific data review, trend identification, data interpretation + Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees… more
- Sanofi Group (Cambridge, MA)
- **Clinical Research Director - allergy-immunology-dermatology** The Clinical Research Director (CRD) is noted as the **primary clinical expert for programs** . ... the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as well as applicable...clinical study report + Take on as necessary the Associate CRD role: + Develop the abbreviated protocol +… more
- Regeneron Pharmaceuticals (Boston, MA)
- …Peripheral Nervous System, Neuromuscular and Muscular Diseases. **As a Senior Medical Director , a typical day may include the following:** + Leads the clinical ... ensure patient safety, ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + With oversight… more
- Marriott (Boston, MA)
- …designing and engineering Cloud Network and familiar with AWS, Azure, Alicloud, GCP + Experience with Firewall technologies like Checkpoint, PaloAlto,Fortinet etc + ... leadership development. + Create and sustain a work environment that drives associate engagement and enables business success. + Ensure appropriate processes are in… more