- Novo Nordisk Inc. (Plainsboro, NJ)
- …tools and dashboards for management tracking and reporting Represents NACD as the subject matter expert on all capacity planning initiatives (locally ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and… more
- Merck & Co. (Rahway, NJ)
- …strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert ( SME ), sharing best practices, making ... quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol defined analysis endpoints (primary, secondary, etc.) thereby serving as a subject matter expert for all external data management business ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...collection and processing requirements are met. Serve as the subject matter expert to data… more
- Merck & Co. (Rahway, NJ)
- …Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject matter expert in CDISC Controlled Terminology and applying ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (North Wales, PA)
- …including assignment of resources, professional-development, and performance management.May serve as a subject matter expert and/or participate on process ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (Rahway, NJ)
- …develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings. Participates in extra ... include, but are not limited to: Creates and develops clinical databases and data transfer files according to written...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Eisai, Inc (NJ)
- …input into the lifecycle management strategies in responsible therapeutic areas. Medical/Scientific subject matter expert : Serve as medical leader and ... strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for... subject matter expert providing direction for assigned products… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study deliverables focusing on data completeness, accuracy and quality. Is an ambassador and Subject Matter Expert ( SME ) for RBDMV. Participates in ... data-driven data quality. This position requires working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications,… more
- Merck & Co. (North Wales, PA)
- …Employee (FBE) training content.-Support Country Medical directors, as HQ point of contact and Subject Matter Expert ( SME ) for medical review.Serve as ... and supply issues.Accountabilities:Medical Review of US and Global Promotional MaterialsProvide clinical expert guidance and advice to Commercial Brand Teams… more
- Merck & Co. (Rahway, NJ)
- …limited to:Utilizes specialist knowledge and experience in dermatology to serve as the company's subject matter expert ( SME ) in companion animal ... our company's Animal Health as a scientific speaker and veterinary professional expert at regional and national meetings by communicating key scientific and… more
- Merck & Co. (Rahway, NJ)
- …them to pipeline assetsCollaborates effectively within and across functional areas and is a recognized subject matter expert in at least one area of drug ... Job DescriptionOur company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working...peer fashion and as a technical mentorRecognized as a subject matter expert in at… more
- Merck & Co. (Rahway, NJ)
- …across functional areas to lead the development of novel drug delivery technologiesIs a recognized subject matter expert in at least one area of drug ... Job DescriptionOur company's Pharmaceutical Sciences and Clinical Supplies (PSCS) organization translates molecules to medicines,...mentoring capabilities to build individuals and teamsRecognized as a subject matter expert in multiple… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter expert ( SME ) to support ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Eisai, Inc (Nutley, NJ)
- …input into the lifecycle management strategies in responsible therapeutic areas. 30%Medical/Scientific subject matter expert : Serve as medical leader and ... strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for... subject matter expert providing direction for assigned products… more
- Merck & Co. (Rahway, NJ)
- …related to automation/OT or IT systems.Participate in audits and training programs as the subject matter expert ( SME ) for area of responsibility. ... play a crucial role in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto Eng position will report… more
- Tris Pharma (Monmouth Junction, NJ)
- …evaluate and communicate safety observations. The incumbent functions independently as a subject - matter expert ( SME ) while working collaboratively ... (ie, Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study Reports (CSRs), etc.); Provides expert safety guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product ... Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of...Lead Develop expertise in one or more focus areas ( SME ) Involved in audits/inspections for safety surveillance and risk… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective compliant training performance leading to sustained right first-time execution. Serve as subject matter expert for Compliance & Training systems. ... for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …enable robust production, testing and release of product to patients. Key Responsibilities Acts as the subject matter expert ( SME ) for 21 CFR Parts 210, ... engineering support to implement and maintain computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data standards and data cleaning needs for DS Programs / Studies.Serve as the subject matter expert for Study Data Managers during the planning/start-up, ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers,… more
