- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QC Microbiology Data Reviewer is an exempt level position with responsibilities for...the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of ... DescriptionThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have… more
- Merck & Co. (Rahway, NJ)
- …Research Division drives breakthrough science through drug discovery, development and clinical evaluation that radically changes approaches to medical need.- Finance ... drives our Company's biopharmaceutical business.Position Description: Associate Director, Finance Clinical Development Finance (CDF) is responsible for overall financial… more
- Insmed Incorporated (San Diego, CA)
- …medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, review & interpretation of clinical trial data, ... and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical … more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …negotiations with clinical sites and vendors as well as budget review and forecasting Independently manage interactions with clinical monitors, data ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe CDT Program Manager is a member of the Clinical Database Testing Team.- As a member of the CDT Team the CDT Program Manager will be involved with ... of CDT SOP's and supporting documentation.May be responsible for compliance review and approval of CDT UAT documentation.Continually monitors for opportunities for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is processed through the appropriate levels of the Standards framework.Participate in review of Protocols, Global Clinical Libraries, Standards package, etc. to ... areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Data Standards is responsible for the development and sustainability of the… more
- Merck & Co. (Rahway, NJ)
- …study start up (eg, database set up) Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with ... DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with PSL(s) or Clinical Safety Physician(s) for assigned product(s) or clinical studies to review and revise CSPs, ICFs, Clinical ... centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary Job Summary The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support , creates, and communicates clinical … more
- Daiichi Sankyo, Inc. (Bernards, 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 physician in evaluating and mitigating safety signals as they… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... Train Field Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources for FMA Train Sales Teams on clinical… more
- Novo Nordisk Inc. (Indianapolis, IN)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... ready to make a difference? The Position Builds relationships and demonstrates the clinical outcome and benefits of Novo Nordisk Inc., (NNI) products. Educates and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data ... Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility and medical questions from sites/… more
