- Merck & Co. (Rahway, NJ)
- … and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new ... regulatory requirements, the competitive landscape, and commercial considerations;Planning clinical trials (design, operational plans, settings) based on these … more
- Merck & Co. (Rahway, NJ)
- …clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study… more
- Insmed Incorporated (San Diego, CA)
- …external audit observations and development of adverse trends) to ensure patient safety and data integrity.Supports strategic direction with cross functional ... to help prepare for inspections is required.Experience developing SOPs, reviewing internal clinical , regulatory and medical processes to ensure they are… more
- Eisai, Inc (Nutley, NJ)
- …role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement strategic vision and hands-on operational management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Genmab (NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data packages… more
- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non- clinical , Clinical , and other functional ... and regulatory postureDemonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.- Strong experience in safety and environmental… more
- Merck & Co. (Rahway, NJ)
- …including complex data preprocessing, filtering, and manipulationProgramming expertise with clinical endpoint data (efficacy and safety ) and ... and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the … more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI ... with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings… more
- Genmab (NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management/oversight. PV experience/knowledge preferred Contracting process for PV vendors (eg Safety Data Exchange Agreement) Excellent interpersonal skills and ... About the Department The Clinical , Medical and Regulatory (CMR) department...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- …have experience in CDISC SDTM and ADaM standards.Must possess programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic ... data , derived PK parameters).Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH.Ability… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Aequor (East Syracuse, NY)
- …experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired. Experience ... testing, reference standard qualification, and comparability studies to support clinical and/or commercial GMP manufacturing. Duties / Responsibilities Develop,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … more
- Insmed Incorporated (San Diego, CA)
- …and procedures suitable for inclusion in IND, NDA, or equivalent regulatory submissions.Must be familiar with BSL-II lab safety requirements.Participate ... ranging from purification development and optimization, process characterization and clinical manufacturing investigation support. As part of this collaborative… more
- Genmab (NJ)
- …Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker functions with the above ... of data consistenciesSupports specification and pooling of data across clinical trials within the same...or ethics committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs… more
- Merck & Co. (Rahway, NJ)
- …robust and scalable upstream processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing… more
