- Eisai, Inc (Nutley, NJ)
- …for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai ... profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …requirements. Relationships This position reports to the Director, Case Review & Compliance Reporting within Patient Safety . This position works closely with ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...not limited to the following: all units in Patient Safety , NNI GXP Support, NNI Legal, NNI Compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations based on potential impact on product quality, patient safety , and regulatory compliance . Address recurring deviations and health authorities' ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Tris Pharma (Monmouth Junction, NJ)
- …is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) ... agreements with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews and/or contributes… more
- Insmed Incorporated (Bridgewater, NJ)
- …of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product ... ensure compliance with company policies and regulatory requirements on safety data reporting, collection, surveillance activities and documentation and that … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... includes operations that support end-to-end GMP clinical supply manufacture and product /process development, as well as oversight of the Enterprise Resource Planning… more
- Merck & Co. (Rahway, NJ)
- …a culture of continuous learning and improvement, scientific and operational excellence, safety , GMP and compliance mindset, and collaboration with various ... Process having participated on a large capital project team.Experience in regulatory compliance expectations across all phases of product development to… more
- Merck & Co. (Durham, NC)
- … - Responsible for creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business.- ... role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend coverage will be… more
- Eisai, Inc (Nutley, NJ)
- …in a dialogue about clinical evidence, approved indication(s), and the product efficacy/ safety profile to support on-label prescribing for appropriate ... the midst of an important launch of a new product in the US focused on educating HCPs on...cross-functionally while adhering to all of Eisai's ethics and compliance standards. Essential Functions Develop and maintain superior clinical… more
- Catalent (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.II. Basic Function: This position is ... responsible for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may… more
- Catalent (San Diego, CA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent ... variety of activities pertaining to supporting, maintaining, and assuring compliance with quality systems requirements and applicable regulatory requirements; to… more
- Merck & Co. (Rahway, NJ)
- …NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions ... and disassembly, cleaning, and processing of raw materials into finished drug product . These individuals are expected to partner with and support formulation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization inclusive of regional Labeling Strategy groups and Labeling Operations Compliance across the development product portfolio. Oversee the processes ... knowledge of scientific, regulatory, and business perspectives to ensure compliance with evolving global regulatory requirements and with company objectives.… more
- Merck & Co. (Millsboro, DE)
- …including charts, log books, and all pertinent documentation.Identifies and addresses compliance , environmental, safety , and process deviations as appropriate ... Good Manufacturing Practices and Standard Operating Procedures and adhere to all safety and company policies while performing advanced laboratory services in various… more
- Catalent (Philadelphia, PA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent ... throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient… more
- Merck & Co. (North Wales, PA)
- …and global scientific content development, review of standard response document (SRD) on product safety and efficacy, and when required, interact with HCPs to ... approach.-Review all medical information resources and standard response documents containing product safety , tolerability and efficacy data. Interact with HCPs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …status as requested. Identify and implement process improvements related to safety , environmental, quality, compliance , productivity, yield, and cost. Implement ... team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators… more
- Merck & Co. (Durham, NC)
- …engineering documents) to support project and future operations.Identifies and addresses compliance , environmental, safety , and process deviations as appropriate ... execution.Maintains detailed knowledge of equipment and processes.Identifies and addresses compliance , environmental, safety , and process deviations as… more
- Catalent (Philadelphia, PA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent ... management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They will… more
