- Edwards Lifesciences (Boston, MA)
- …+ Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (eg, clinical study reports, clinical ... and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing...Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle +… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing , regulatory operations, etc.) to develop global regulatory plans, ... experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical ...in regulatory affairs or related areas (eg, clinical development, project management, quality assurance, etc.) in pharmaceutical… more
- Cardinal Health (Boston, MA)
- …in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role. + Experience writing scientific documents for regulatory or ... to Cardinal Health** The Clinical Affairs function manages the clinical education, medical writing and communications, research, health care economics… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …and investigator registrations, clinical trials education, and committee management. The Clinical Trials Education Manager reports to the Director of ODQ. ... The Clinical Trials Education Manager is responsible for supervising and overseeing...and Education Subcommittee; recommending policy changes, and draft policy writing + Distribution of draft policies for comment, collection… more
- Beth Israel Lahey Health (Boston, MA)
- …not just taking a job, you're making a difference in people's lives.** A Clinical Manager is responsible for delivery of effective laboratory service by ... Responsibilities:** + Ensures staffing and training in their section, meets clinical demands and provider expectations for workload, including meeting turn around… more
- Sanofi Group (Cambridge, MA)
- … clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from various disciplines; serve ... Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory ...level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies. SMM… more
- Olympus Corporation of the Americas (Westborough, MA)
- …commercialization of Olympus's portfolio. Specifically, this individual will be responsible for writing clinical study protocols, case report forms, and study ... between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs, and investigational sites. + Ensures clinical studies are… more
- Tufts Medicine (Boston, MA)
- …**Preferred Qualifications:** 1. Experience in the following areas of clinical research: budgeting, project management, compliance, regulatory management, ... in accordance with policies. 2. With support from their manager , reviews clinical research protocols for resource...advises principal investigators, researchers, and staff in the compliant clinical , regulatory , and fiscal conduct of all… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Astellas Pharma (Westborough, MA)
- …cGMP Cell Therapy Manufacturing facility in Westborough, MA as products move through clinical trials and commercialization. The Validation Manager will be a ... **Validation Manager ** Do you want to be part of...of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and… more