- Merck & Co. (Rahway, NJ)
- …and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business processes.Core Responsibilities may include ... Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs &… more
- Merck & Co. (Rahway, NJ)
- …in some 150 markets.Primary Responsibilities: Accountable for all environmental, health, and safety (EHS) program execution and compliance at a portion of our ... site, region, and global business partners to drive prioritization of regulatory compliance, continuous performance improvement, and integration of EHS performance… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... capture all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... of Director in the CCFS group and working in conjunction...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device ... medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …seasoned leader to strengthen and grow the Learning and Development program across the Regulatory - Safety - Quality (RSQ) function. In this role you will evolve ... and help create possible, together. **Job Description** The Central Quality Services team within R&D Quality is...program effectiveness + Foster and drive a culture of quality and continuous improvement across RSQ and Development **Change… more
- Merck (Rahway, NJ)
- …and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business processes. Core Responsibilities **may** ... **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory … more
- The Coca-Cola Company (Whitestone, NY)
- …or relevant science discipline required. **Job Description Summary** : The Director , Scientific and Regulatory Affairs Compliance and Innovation develops, ... improves, and drives compliance to all Regulatory requirements at BODYARMOR. In addition, this role also...+ Assess and approve all new suppliers + Lead Quality and Food Safety audits of all… more
- Edgewell Personal Care (Allendale, NJ)
- …of Canadian Registration Processes and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance. + Proven ability ... the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing,… more
- Ross Stores, Inc. (New York, NY)
- …with continuous learning opportunities and development for our teams\. **GENERAL PURPOSE:** The Director , Product Compliance & Regulatory Attorney will work as a ... broad range of topics and projects in the areas of product compliance, regulatory compliance, product safety , environmental, and risk management\. The position… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... via contact reports. + Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety ...all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Hackensack Meridian Health (Edison, NJ)
- …mission to transform healthcare and serve as a leader of positive change. The ** Director of Patient Safety and Quality , Inpatient** , provides leadership, ... outcomes. **Responsibilities** A day in the life of a ** Director of Patient Safety and Quality...and analysis. + Stays abreast of and communicates all regulatory compliance changes and incorporates findings into all resident/patient… more
