- Daiichi Sankyo, Inc. (Bernards, NJ)
- …As CSL for Phase 2 studies: Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …As CSL for Phase 2 studies: Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(CSL)Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Merck & Co. (North Wales, PA)
- …protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring team in review and interpretation of ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you… more
- Merck & Co. (Rahway, NJ)
- …is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with ... We are part of the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our company's research division.The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& retention activities Obtain expert medical community input Regulatory liaison: Write and/or review clinical sections of clinical trial reports, statistical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...as Site Selection and Initia-tion trainings for the monitors Review medical monitoring plan and conduct monitoring… more
- Novo Nordisk Inc. (Irvine, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... lead and biostat to ensure availability of necessary dataCoordinate author review /approval & internal review approvalSubmit abstract/manuscripts with vendor… more
- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... objectives.Serve as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising… more
- Merck & Co. (Rahway, NJ)
- …a new multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with ... liquid suspension/bottle fills, and autoinjector assembly. This team produces clinical and development drug product batches in a GMP...is required, as the successful candidate will be a reviewer and approver.- Regular feedback and coaching is a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review Plan - Accountable for the assessment of ... Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing...if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Novo Nordisk Inc. (Atlanta, GA)
- 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...a difference? The Position Builds relationships and demonstrates the clinical outcome and benefits of Novo Nordisk Inc., (NNI)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …outbound and inbound sample shipment manifests,and tracking ad hoc shipments in trackers) Review the CRO partner Sample Management Plan , to document ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This...the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo… more
- Merck & Co. (Upper Gwynedd, PA)
- …Affairs to remain on the leading edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory, reputational, ... of medical goals and strategies that inform and demonstrate scientific & clinical value and address insights from affiliates and regions including clinical… more
- Merck & Co. (North Wales, PA)
- …reviewers to ensure it meets regulatory requirements while leading the summary through review and final approval - Collaborating with clinical teams , request ... health literate , and non-promotional - R esponding to clinical and legal review comments on PLS;...and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related integrated evidence generation strategies and activities as part of the USOMA Plan . Provides medical review of expanded access programs (EAP) and, ... supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people...Medical Affairs (USOMA). Develops the USOMA strategy and tactical plan as part of the US Brand Strategic … more
- Eisai, Inc (Nutley, NJ)
- …provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through ... other medical and/or scientific information with external customers (Health Care Providers, researchers, professional organization leadership, and population-based decision… more
