- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing ... efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers and other clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of ... research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position Responsible for managing day-to-day operations of pharmacy programs. This person will be responsible for driving new ... and reports insightful metrics to relevant groups contributing to pharmacy operations to assess operational performance. This individual will maintain a high-level… more
- Eisai, Inc (Dallas, TX)
- …want to hear from you. Job Summary The Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL) is a field-facing representative of US Medical ... Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as a conduit for communication between Eisai… more
- Merck & Co. (Rahway, NJ)
- … Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) ... and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders.--Responsible and accountable for utilizing… more
- Merck & Co. (Rahway, NJ)
- …the Sr Principal Scientist Patient-Centered Endpoints & Strategy (PaCES) lead, the Senior Scientist has responsibility for coordinating global Clinical Outcomes ... from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and executed… more
- Merck & Co. (Rahway, NJ)
- …deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders.--Works directly in the SAP ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… more
- Eisai, Inc (Philadelphia, PA)
- …the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between ... FUNCTIONS: Product/Therapeutic Area Support to Stakeholders Act as the primary clinical /scientific resource to HCPs in the territory for information pertaining to… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing... supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems including data management, statistical programming, digital technologies, and clinical operations .Design and implement a fit-for-purpose organization ... have 10 or more years of professional experience in Quality, IT compliance and clinical development in the pharmaceutical industry with involvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (South San Francisco, CA)
- …to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong, ... efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers while aligning with live agent support programs. The Digital Operations role is responsible for ensuring necessary framework, processes, and business ... rules are in place to execute and manage operations across the patient support ecosystem. In addition to managing the current suite of services, this person will… more
- Merck & Co. (Rahway, NJ)
- …in the Formulation, Laboratory, and Experimentation (FLEx) Sterile GMP Clinical Manufacturing facility.Contribute to equipment and facility design, system ... quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the… more
- Merck & Co. (North Wales, PA)
- …Data Management ( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and Indirect (eg, ... for GRACS and other critical stakeholder areas including PV, Clinical and Supply Chain to ensure that datasets are...enable f uture proofing of regulatory submissions and ensuring compliance with evolving standards beyond 2025 ( ie IDMP… more
- Eisai, Inc (Exton, PA)
- …Eisai is choosing, deploying and supporting computing platforms and solutions in compliance with applicable global regulations and in accordance with Eisai standards ... and senior management intentions. Through a GxP Systems Quality Assurance...(QA) processes, procedures, and systems (including QMS) to assure compliance with applicable GxP regulations and company standardsScope includes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …but are not limited to: Marketing, Account Management Teams, Finance, Medical, Operations , Compliance , & Legal.Will be required to facilitate classroom training ... Teams, Field Reimbursement Managers, Field Sales Forces, Marketing, Oncology Clinical Nurse Educators, Oncology Market Alliances and other appropriate stakeholders.… more
- Merck & Co. (Durham, NC)
- …support the business including the following: Product/ Process Development, Manufacturing Operations , Finance, Regulatory, Quality, Compliance , Supply Chain and ... Managers have direct impact on cost, quality, customer service, and compliance which ultimately affects access, continuity of supply, and commercial outcomes.The… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
