- Merck & Co. (Rahway, NJ)
- …responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining and optimizing ... training process standards and strategies to ensure optimal quality and compliance in GRACS business processes.Core Responsibilities may include and are not… more
- Merck & Co. (Rahway, NJ)
- …managementExperience with quality systemsFamiliarity with US and EU GMP and Safety compliance regulationsExperience with SAP, ERP or MES systemsFamiliarity ... Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate...based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations &… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The … more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as alliance partners, promoting a cohesive team approach.Regulatory and Safety Compliance : Understand study conduct from supply chain/drug forecasting to ... areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: ... responses submitted to health authorities globally with respect to data standards, compliance , etc. May represents the function at health authority meetings. Reviews… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical ... systems and architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business leadership in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... the Supply Chain business. Relationships Reports to the Senior Director , Supply Chain and is in direct contact with...Manage the DSA creation and amendments and ensure ongoing compliance to the requirements and conditions Lead the reporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... even under adversity Operational mindset and continuous improvement: Considers compliance , regulatory, quality assurance and other requirements when supporting all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director of Data Stewardship, Cataloging and Process, develop implement a data ... from multiple functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital...Records, Electronic Signatures o 21 CFR § 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... improvements and seek agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement Team and will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... improvements and seek agreement through consensus management.RelationshipsReports to an Associate Director / Director within the NNI Procurement Team and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …at Novo Nordisk, Inc. RelationshipsThe fellow will report to the Fellowship Director throughout the two-year program and will also have a reporting relationship ... (eg, clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical communications; responses… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and compliance . Relationships This role reports to the Associate Director -Patient CRM Product Owner. Collaborates cross-functionally with internal teams, such as ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:Market & Collateral Risk Management - Director The Team Join Fidelity's Collateral & Market Risk Management team to help protect the firm from ... of the firm's stress testing and margining processes.Partner with Compliance to draft responses to regulatory inquiry and/or meet...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Brand Marketing, Training, Commercial Insights and Analytics, Managed Markets, Legal, Compliance , and Finance. The position has high exposure to senior management… more
