- 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...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to collaborate with, and support the head of Global QA strategy and operations . In this position, the incumbent will take on organizational responsibilities relevant ... tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA,...to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... functional teams and various departments to include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain Technical Operations , Pharmaceutical Technology… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , Site Services Procurement (NORAM) This Procurement Associate Director role will be a member of ... and spoken).Preferred Experience and Skills:MBA or advanced degree.Understanding of regulatory requirements and industry standards related to site services within… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Merck & Co. (Rahway, NJ)
- …safe, sustainable and healthy future for people and communities everywhere.The role of Associate Director , ESG Strategic Reporting is a unique opportunity to ... from voluntary to regulation-driven disclosures.The role will report to the Director , ESG Strategic Reporting. Primary Responsibilities: Manage ESG reporting and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure ... successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of...of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global ... Strategy and Operations . In collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations ,… more
- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director , Clinical ... process, and contract review. Act as primary point of contact from clinical operations for assigned trials. Oversee study start up activities of CROs (eg Site… more
- Merck & Co. (Rahway, NJ)
- …Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific ... communication skills, both verbal and written. Education Minimum Requirements: Associate 's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or… more
- Merck & Co. (Rahway, NJ)
- …assigned accounts.- The Senior Consolidation Accountant reports directly to the Associate Director of Consolidation Accounting.Primary responsibilities for this ... quality of the financial information provided to investors and regulatory bodies, and the relevance of the financial information...your employment may pose an undue burden to business operations , in which case you may not be offered… 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...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- New York State Civil Service (New York, NY)
- NY HELP No Agency Office of Cannabis Management Title Special Assistant (Deputy Director Division of Licensing and Regulatory Compliance) - VID 168292 ... licensing operation, gathering feedback from stakeholders to improve licensing operations , and training and developing licensing staff.OCM's Regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations . The Associate Director , will be a key member ... of non-compliance. + Maintain awareness of changes within the industry and regulatory environment to ensure Clinical Operations alignment + Determine, develop,… more
- City of New York (New York, NY)
- …systems, new approaches to government, and a strong focus on its employees. The Director will manage the Regulatory Reform team within the Division of Business ... Services reporting to the Assistant Commissioner of Government Navigation and Regulatory Reform. The team's mission is to ensure that New York City's rules and… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The ** Associate Director , Cryo Operations ** leads a team of Senior Managers, Managers, ... for the space within CAR T clinical and commercial operations in Summit, NJ. This position plays a critical...while maintaining appropriate level of controls and compliance with regulatory requirements + Ability to travel 5% - 10%… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The ** Associate Director , Cleanroom Operations ** , leads a team of Senior Managers, ... & EM Sampling within CAR T clinical and commercial operations in a several cGMP multi-cleanroom suite as well...while maintaining appropriate level of controls and compliance with regulatory requirements + Ability to travel 5% - 10%… more
