- 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- … investigations and change management.Familiarity with US and EU GMP and Safety compliance regulationsExperience in Process Hazard Analysis (PHA) and/or Level ... provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to the Director ,… 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)
- …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
- 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
- Robert Half Finance & Accounting (Edison, NJ)
- Description Robert Half is seeking a highly skilled and motivated Compliance and Safety Director for a growing client in Central NJ. In this critical role, ... + Collaborate with Managers to establish and implement strategic goals for compliance and safety . + Maintain accurate records and update policies to comply with… more
- Danaher Corporation (New York, NY)
- …lives with diagnostic tools that address the world's biggest health challenges. The Senior Director of Medical Safety and Compliance will lead the Medical ... Safety & Compliance team, ensuring that Medical & Scientific Affairs are...role is crucial in maintaining high standards of medical safety , compliance , and regulatory adherence at Beckman… more
- The Mount Sinai Health System (New York, NY)
- …(Hospital and School), and the Chemical Shipment Program. Ensures compliance with institutional, local and federal regulations, with continual preparation ... and/or frequency) 1. Management of hazardous waste operations, including compliance oversight and staff training/documentation for 350 + research laboratories,… more
- KPMG (New York, NY)
- **Business Title:** Director , Consumer Compliance **Requisition Number:** 118205 - 68 **Function:** Advisory **Area of Interest:** **State:** NY **City:** New ... a career in Advisory. KPMG is currently seeking a Director in Consumer Compliance for our Consulting...regulatory compliance with a focus on consumer compliance and safety and soundness regulations at… more
- New Jersey Institute of Technology (Newark, NJ)
- Title: Associate Director of Health and Safety Department: Office of the Dean - NCE Reports To: Dean, Newark College of Engineering Position Type: Staff Position ... Summary: The NCE Associate Director of Health and Safety works closely...and disseminates policies and procedures designed to increase the safety , well-being, and compliance of NCE facilities… more
- Educational Alliance, Inc. (New York, NY)
- …wellness, arts and culture, and civic engagement. The Role: Under the direction of the Director of Compliance , the Associate Director of Compliance is ... Recovery Wellness (CRW) residential and outpatient components. The Associate Director of Compliance will oversee the adherence...+ Conduct facility walkthroughs to ensure building is in compliance with safety regulations + Track and… more
- City of New York (New York, NY)
- … Director of Administration Planning Operations and Emergency Support Services, the Director of Contracts and Compliance with wide latitude for independent ... largest domestic shelter system in the country which provides safety and services for this vulnerable population. This network...(1) Administrative Staff Analyst NMII to function as the Director of Contracts and Compliance who will:… more
