- Merck & Co. (Rahway, NJ)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of ... collection and management, and external data monitoring committee for ophthalmology clinical trials.Experience with review of participant eligibility for trials… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... quality management and inspection management activities.The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams providing the safety leadership and serving as the primary point of contact. Review and analyze data from clinical trials, post-marketing and other relevant ... around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure the ... effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent DSPD Clinical … more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible ... for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the… more
- Merck & Co. (Cincinnati, OH)
- …RMSD Team Leader - within US Medical Affairs, Global Clinical Development, Research and Development (R&D).--Primary Activities:Identify, establish and manage ... collaborative professional relationships with national, regional and clinical practice scientific leaders (SLs) and investigators to identify and address scientific… more
- Merck & Co. (Rahway, NJ)
- …that address asset value proposition, insights from affiliates and regions, and clinical and value evidence gaps. Translate these Goals and Strategies into research, ... a valued co-strategist on asset cross-functional meetings: Franchise Teams, Clinical , Value-Evidence, Risk Management, and Commercial Product Development Subteams,… more
- Eisai, Inc (Nutley, NJ)
- …strategic development, planning, implementation, and oversight of Phase I through IV clinical trial programs and early new product development within the Medical ... for assigned product(s). The Associate Medical Director utilizes expert medical, clinical and scientific knowledge in assigned therapeutic area to provide tactical… more
- Aequor (Thousand Oaks, CA)
- …demonstrate commitment and long-term stability. Associate Supply Chain Description: As an Associate, Clinical Supply Chain, you will play a key role in ensuring ... clinical drug products are distributed globally to ...return of investigational products Temperature Data & Quality: - Review shipment temperature data and assess excursions with Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities- Oversee the quality and timeline of vendor work- Collaborate with study clinical or medical lead and biostats to ensure availability of necessary data- ... Coordinate author review /approval internal review approval- Abstract/manuscript submission with...including authors, researchers, investigators, GMA Therapy Area leads, RD clinical leads, biostatistics and Joint Publications Team members on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This ... Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs). ... QA, Development QA, and PVQA) to address GxP-related issues impacting clinical /medical access programs. Drive necessary change and efficiency through provision of… more
- Novo Nordisk Inc. (Forrest City, AR)
- …assess, create and maintain advocacy of customers aligned to company, brand and clinical goals. The OCS develops local strategies and executes local tactical plans ... partners. The OCS also assists their customers with their local clinical and educational initiatives by coordinating company resources (eg, counterparts, materials,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.- Provides support in… more
- Genmab (NJ)
- …through scientific exchange in a fair and balanced manner and provide clinical /scientific support for Genmab's pipeline.Domestic travel of approximately 50% will be ... regional, national, and global Medical Affairs strategiesProvide insights/feedback on emerging scientific/ clinical data that enhance the value and appropriate use of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have ... risk management. Responsibilities Leadership, Direction, and Strategy: - In collaboration with Clinical Development and Clinical Operations as well as other BDM… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in ... management strategies in responsible therapeutic areas.Plan and implement Phase IV clinical development programs for assigned products.Create IIS strategies and … more
- Insmed Incorporated (San Diego, CA)
- …regulations, regional guidance documents and ICH guidance documentsRegulatory writing and/or review of documents supporting product development and clinical ... to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the compound.- Responsible for scientific communications and publications; interpretation of clinical data; ensuring consistency of clinical content and ... (ESRs) and may serve as deputy regional medical lead in Global IIS Review Committee meetings. May serve as medical lead for select company-sponsored evidence… more
