- Merck & Co. (Rahway, NJ)
- …cost estimates requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...as well as supply chain documentation to support critical CMC activities. - - Support… more
- Merck & Co. (North Wales, PA)
- …(MW&D) department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance ... in public disclosure of clinical trials and their results, document disclosure, and data...disclosure, and data sharing with external researchers. - The Director , Disclosure Quality & Compliance is responsible for independently… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director - Purification Technology Lead within the Vaccine Technical Operations organization will be responsible for tactical and ... decisions related to tech transfer and process stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, regulatory… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Associate Director , R&D CTMS Operations Lead will lead the business operations team in one ... systems/capabilities with the R&D functional area, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug… more
- Genmab (NJ)
- …Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… 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 ... for a living. Are you ready to make a difference? The Position Executive Director , Patient Safety Case Management is responsible person for USO Patient Safety Case… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules ... and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated environmentAbility… more
- Merck & Co. (Boston, MA)
- …and protocol developmentDrive RWE implementation activities, including writing detailed documentation that align to study objectives and analysis plansAccountable ... statistics, biostatistics, econometrics, data science, biomedical informatics, health informatics, clinical informatics, epidemiology, health economics, biometrics, operations research, engineering,… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- …of our R&D team that designs and develops benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for drug delivery systems. ... Reporting to the Director responsible for this area, you will partake in...semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as equipment SME, assist with FAT,… more
- Merck & Co. (Rahway, NJ)
- …of engineering fundamentals . The Process Supervisor position will report to the Associate Director , MACS Operations and will be a member of the EF Team at the ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... internal manufacturing sites. Relationships This position reports to the Associate Director of Drug Substance Development and Manufacturing. This position interacts… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.A… more
- AdventHealth (Orlando, FL)
- …The Clinical Documentation Manager will report directly to the Regional Clinical Documentation Director and will work extensively with CDI teams, ... (SOI) and risk of mortality (ROM) in cooperation with the Director of Clinical Documentation Improvement and all other operational hospital departments.… more
- R1 RCM (Salt Lake City, UT)
- …Development Director at R1RCM, you will be responsible for selling Clinical Documentation Improvement and Coding Solutions. This position is responsible for ... cycle management. **Every day in this role you will:** + **** The Director will be responsible for pursuing, developing, and sustaining CDI and coding sales… more
- AdventHealth (Maitland, FL)
- …the strategic and operational planning, design, implementation, and oversight of the Clinical Documentation Improvement (CDI) program at Florida Hospital. The ... to improve the overall quality and completeness of both electronic and paper-based clinical documentation in adherence to industry best practices. S/he will… more
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