- Merck & Co. (Rahway, NJ)
- …regulatory review and final approval of all submissions and associated documentation .Provides expertise as the Global Regulatory Lead to Product Development Teams ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of microbiology data reviewers supporting the reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and ... testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead… more
- University of New Mexico - Hospitals (Rio Rancho, NM)
- …and attending in-services, meetings and workshops * RESOURCE - Act as a clinical resource and role model for department personnel * EVALUATION - Administers or ... ability to document and communicate pertinent information using computer and/or paper documentation tools in a timely and accurate manner * SHIFT ASSIGNMENTS -… more
- Beth Israel Lahey Health at Home (Beverly, MA)
- …and Federal HIPAA guidelines; Demonstrate proficiency in OASIS completion; Complete documentation through EPIC in accordance with agency timeliness policies. What ... apply) Opportunity to earn up to an additional $8,000 annually based on clinical achievements A reasonable geographic territory with strong clinical support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes ... working in an aseptic manufacturing facility, preferably in quality assurance,manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of… more
- Mount Auburn Hospital (Cambridge, MA)
- …in maintaining recognized standards, policies, and procedures. 3. Maintains and updates clinical knowledge and skills based on current nursing and health care ... care, implements the plan of care, and evaluates results as evidenced by documentation in accordance with the policies and standards set by the Nursing Department.… more
- Merck & Co. (Rahway, NJ)
- …achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... and scalable upstream processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for successful… more
- Aequor (Athens, GA)
- …in accordance with study protocols, completes and maintains appropriate documentation associated with all job assignments, and provides equipment sanitation ... the direction of the Site Veterinarian or delegate. Conducts scientific clinical observations and disease outcome assessments. May administer experimental treatment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be ... creation, revision and review of change controls, SOPs, and other documentation Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project… more
