- Novo Nordisk Inc. (Plainsboro, NJ)
- … safety promotional review, safety labelling committee input, safety data analysis and contract review and vendor management for vendors handling ... outputs using suitable Pharmacovigilance database retrieval strategies Experience with safety data collection and interpretation originating from clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … management experience in PV required- 10+ years of Drug Safety /Pharmacovigilance experience, including both investigational and marketed products ... Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, ... External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global Safety … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety ... reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other...clinical sections of study-level documents (eg, protocol, amendments)- Reviews safety data to mitigate risk to trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting ... (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other...of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial… more
- Merck & Co. (North Wales, PA)
- …proceduresDemonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug /vaccine developmentPreferred Skills and ... the benefit of patients and global human health. Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Tris Pharma (Monmouth Junction, NJ)
- …and execution of all development studies and ensures proper evaluation/trending of stability data for New Drug Application (NDA)/Abbreviated New Drug ... In depth knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA),… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and formulating business relevant strategic recommendations Strong understanding of drug development, commercialization, and lifecycle management Works ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency ... and implementation for mechanical systems and equipment, and work order management for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …documentation in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. Supervisors will drive employee and equipment ... policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities:Ensure/adhere to garbing and behavior requirements that align… more
- Genmab (Plainsboro, NJ)
- …strategies that drive business results and successful commercialization of new drug entities and assets.Excellent leadership and team management skills, ... and in a compliant manner with colleagues in other functional areasEnsures optimal safety , clinical oversight and highest quality standards are applied to all US… more
- Aequor (Northborough, MA)
- …of packaging completion. Use computer-based systems for data collection, data analysis, timecards, e-mail and inventory management . Follow both written ... Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for sale and distribution to US,… more
- Merck & Co. (Rahway, NJ)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety ; promote a culture of diversity, inclusion, ... DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences… more
- Genmab (Plainsboro, NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Group Lead, Finishing will rely on ... corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities: Comply with garbing and behavior requirements that… more
- Merck & Co. (North Wales, PA)
- …an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsDemonstrated ... experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, listings)Strong project management skills;… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. This position supports the ongoing development, ... policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities:Maintain clean room environment by complying with garbing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data , developing and ... department projects.Key Responsibilities Ensuring adequate training (skills-based, cGMP and safety ) of associates within the department.Be responsible for managing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support specific and real time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data entry, ... according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.Perform tasks on time in… more
