- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...biotechnology experience in one or more key functions (eg clinical operations , clinical research, … more
- Merck & Co. (Rahway, NJ)
- …and innovative solutions that enable new SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , you ... will be responsible for delivering SAP solutions to our Global Clinical Manufacturing user community. You will p articipate in interviews with our company's'… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … more
- Merck & Co. (Rahway, NJ)
- …of the MACS EDFE Leader include the following:The EDFE Leader role at the Associate Director level will serve as a technical mentor and process team ... and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The Associate Director will serve as a team member of the MACS Center Basis… more
- Merck & Co. (Rahway, NJ)
- …risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead ... ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key company functions.Represent Device… more
- Merck & Co. (Rahway, NJ)
- …to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …reference laboratories, etc.) is fundamental to the success of the role.The role as Director will report into Associate Vice President, Precision Medicine and be ... immunology. The Position: We are currently recruiting for a Global Immunology Marketing Director , Precision Medicine. This is a key leadership role that will be… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will ... plus. required Experience QualificationsStrong experience and expertise in end-to-end clinical operations functional understanding and execution, including… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Automation Engineering (Auto Eng) Team within the Pharmaceutical Operations Engineering (POE) Department is seeking a highly motivated and ... a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Engineering Auto Eng position will report to the … more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is ... a member of the Clinical Business Operations team within Development Operations and provides oversight and leadership across clinical programs/trials in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog along with ... / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption...Minimum 7 years' experience in life sciences, pharma with Clinical Trials Operational Data, Clinical Operational Metrics… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's ... portfolio and continued support as a key partner to Clinical Development, Real World Evidence and Commercial Operations...AD congresses and medical advisory boards, and scientific communication.The Associate Director is a key member of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... and Regulatory Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyCreates a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... Daiichi Sankyo, Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs and labelling.-… 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 ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
