- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Manager , Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global ... Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data Management within the Global Data Management & Standards (GDMS) organization, the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the ... other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Merck & Co. (Rahway, NJ)
- …as needed.Works in partnership with GCTO (Global Clinical Trial Operations ) country operations , finance, regulatory affairs, pharmacovigilance, legal ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager ,...clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC… more
- Merck & Co. (Rahway, NJ)
- …as needed.-Works in partnership with GCTO (Global Clinical Trial Operations ) country operations , finance, regulatory affairs,-pharmacovigilance, legal ... Job DescriptionWith support of Sr CRA ( Clinical Research Associate) and/or CRA Manager ,...Related CR ( Clinical Research) experience may include Clinical Trial-Assistant, Study Coordinator, Regulatory CTC (… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This ... vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs,… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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
- 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 ... trials, some of more recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical, biotechnology, CRO, and/or healthcare… more
- Aequor (NJ)
- …and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners. Collaborating with Global Clinical ... during phases 1-4. The individual must partner closely with clinical , regulatory , quality and production associates to...CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of External Vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing ... diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), ... including experience in one or more key functions (eg, clinical research, clinical operations , data...and metrics dashboarding preferred- Understanding of industry trends (eg, regulatory , technology) with ability to apply them to process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... Value process in evaluating study budgets.Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Irving, TX)
- …and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and ... summarizing clinical and marketing support trials specific to dairy animal...event reporting, dealing with dairy health issues in customer's operations , customer complaints and education on new products from… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the… more
- Merck & Co. (Ames, IA)
- …and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and ... summarizing clinical and marketing support trials specific to Ruminant animal...event reporting, dealing with Ruminant health issues in customer's operations , customer complaints and education on new products from… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness ... QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical... programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations … more
