- Northeast Georgia Health System, Inc (Gainesville, GA)
- …a foundation of improving the health of our communities. About the Role:Job SummaryThe Research Regulatory Specialist performs a wide range of tasks ... essential to the submission, approval, and maintenance of required regulatory documents for conducting clinical research in...of required regulatory documents for conducting clinical research in compliance with the Federal Food and Drug… more
- DivIHN Integration Inc (Columbus, OH)
- …of us to learn more For further information please contact our Talent Specialist : Rashi | 630 8471027 Title: Medical Safety Reviewer Location: Columbus, OH Duration: ... of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Durham, NC)
- …seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating Priorities.Invent-- Pursue the ... product and support laboratory testing for vaccines.The Quality Control Laboratory Associate Specialist participates on a team of analysts in the method transfer,… more
- Merck & Co. (Durham, NC)
- …vaccines in the Global Vaccine and Sterile Manufacturing organization.The successful Specialist candidate will be energetic and technically sound, with strong ... these programs.Author, review, and/or edit validation documents to support regulatory filingsSupport Change Control documentation for complex process, validation,… more
- Merck & Co. (Durham, NC)
- …ingredient, finished product, and laboratory testing for the BCG vaccine.The Associate Specialist participates in a team of analysts in the development, validation, ... validation, and GMP laboratory readiness.- The Quality Operations Laboratory Associate Specialist performs laboratory testing on a variety of product samples and… more
- Merck & Co. (Durham, NC)
- Job Description Position Description: The Quality Operations Laboratory Associate Specialist performs laboratory testing on a variety of routine waters, product ... neededCollaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirementsProvides active support during audits and inspections (… more
- Merck & Co. (North Wales, PA)
- …library componentsParticipates in standards data governance reviewsThe GCDS Data Standards Specialist may contribute to the definition and maintenance of business ... the area and/or companyMaintain knowledge of new technologies, industry standards, regulatory requirements, and our Company guidelines and SOPs.Able to work… more
- Merck & Co. (Durham, NC)
- …continuous improvement projects which may require change controls or have regulatory impact.Author and update GMP documentation including but not limited to ... routine collaboration with external stakeholders, such as customer-facing commercial, or research -based roles, will be expected to comply not only with Company… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: As a member of our company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance ... controls, auditing and Quality Risk Management.As required, participate in Regulatory Agency inspection activities.Deliver stewardship for company's corporate initiatives… more
- Merck & Co. (Durham, NC)
- Job DescriptionDurham's Technical Services Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills to ... manufacturing process.Author, review, and/or edit technical documents to support regulatory filings including technical protocols, reports and risk assessments.Support… more
- Merck & Co. (Rahway, NJ)
- …completion of carefully designed clinical trials is critical to drug development.The Specialist , Clinical Trials Communications role within our Research & ... key stakeholders and setting agendas for each meetingSupport on legal/compliance/ regulatory reviews on external facing materialsSupport with community engagement and… more
- Eisai, Inc (NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities Essential… more
- Merck & Co. (South San Francisco, CA)
- …DescriptionResponsibilities:Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to ... reports. Interact with colleagues from multiple areas, including discovery, regulatory affairs, project teams, and development functions.Partner with scientists and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials ... produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist , Associate Director, is a subject matter expert in CDISC… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Specialist is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing ... of 3 yrs of aseptic processing/sterile manufacturing experience.-Experience with regulatory audits and working knowledge of data integrity principles. -Understanding… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... mild cognitive impairment due to Alzheimer's disease (AD) or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team of sales professionals who… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters in MA. Internal relationships include… more
- Merck & Co. (Rahway, NJ)
- …of the current IT division that provides support to the Pharmaceutical Research , Supply Chain, Marketing organizations as well as Enabling Functions. The EIT ... other SAP and non-SAP Business Areas, Digital Manufacturing Division, Compliance, our Research & Development Division Value Team, GSMG etc. Hold accountability for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The ... QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to be part of the team responsible for Warehouse activities that will… more
