- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (eg Protocol Amendments, ... areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... (IR) and pre-approval Inspection preparation activities for global clinical operations , responsible for representing the GCO-CQM inspection readiness within the… more
- Merck & Co. (Durham, NC)
- …supply to customers and patients on time, every time, across the globe.The Manager , Quality Operations (QO) Microbiology will be responsible for leading and ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- USAA (Phoenix, AZ)
- …other. Come be a part of what makes us so special!The Opportunity As a dedicated Manager , Claims Operations , you will lead a team of Sr. Injury Adjusters. This ... Claims for the Western Region. In this role you will lead auto claims operations member service employees who are responsible for serving our members, and providing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… 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. (Rahway, NJ)
- … Operations .Collaborates internally with HQ functions, regional and local operations , EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global ... Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned… more
- Merck & Co. (Rahway, NJ)
- …Point of Contact (POC) for assigned protocols and link between Country Operations -and clinical trial team (CTT).- Responsible for project management of the assigned ... Visits Reports and escalates performance issues and training-needs to CRA manager and/or functional vendor and internal management as-needed.o Performs Quality… 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...environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments,… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations of the LBRI Office of ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Aequor (Seattle, WA)
- Job Description: Position: Technical Project Manager Location: Seattle WA Top Skills: 5&plus years' experience in bio tech/life sciences project management; cell ... CMC drug development. Familiarity with alliance management Job Description The Technical Project Manager (PM) will be a key member of the Cell Therapy Development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... effort will have a focus related to industry available cell therapy unit operations to be incorporated with an automation platform that integrates with MES systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible ... Programs to assure product quality, integrity and compliance with regulatory guidelines and internal/global standards and procedures. Responsible for managing… 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 collecting… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Alzheimer's Disease - Site of Care Marketing will assist with the development and ... education of infusion centers. This work stream will involve partnering with our operations team to manage the operation and logistics associated with the CE… more
- Aequor (Thousand Oaks, CA)
- …Able to manage performance issues and conflict Ability to evaluate documentation/ operations according to company and regulatory guidelines Ability to interact ... skillsets. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility FUNCTIONS May perform or oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and workstream implementations for effectiveness.-monitor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data… more
- Merck & Co. (Rahway, NJ)
- …business processes as well as alignment with Finance, IT, and functional area operations groups within Merck. -Your Fellowship ProjectWe are seeking an energetic and ... tactical input from diverse disciplines (eg, biology, chemistry, pharmacology, clinical, regulatory , access, supply, and other areas), as applicable to the project.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and… more
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