- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... 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)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise… 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)
- … Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management, Quality Assurance, Medical Affairs, ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. Work with the business users… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management, Quality Assurance, Medical Affairs, ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
- Merck & Co. (North Wales, PA)
- Job DescriptionLead and develops the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to ... both a system and process prospective.Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits.Lead efforts to… more
- Merck & Co. (North Wales, PA)
- …Required Experience: 10-15 years of Pharmaceutical Industry experience. Quality / Regulatory and Digital Enablement experience strongly preferred.Experience ... of digital transformation in the biopharmaceutical industry. As a Director of Content Management, you will play a pivotal...you will play a pivotal role in simplifying our Quality Management System (QMS) technology stack and enhancing user… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...product development, control strategy, and specifications-setting.-Deep working knowledge of regulatory guidance and quality standards, with experience… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Merck & Co. (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, ... will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.Manage a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Provide medical and scientific input to labelling Assist in the interpretation of regulatory guidelines and directives to judge risk and causality Medical and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Program Management, the Associate Director , Program Management ... and will drive the development, creation, and implementation of high quality , global, coordinated cross-functional project plans for products in accordance with… more
- Merck & Co. (Durham, NC)
- Job DescriptionAs the Vaccine Automation Director , you will be the primary point of contact for the HPV IPT for all digital implementations, support, and ... the liaison between above site DMO and the site clients.- The Vaccine Automation Director works with the HPV IPT, Supply Chain, and Technical Operations site leads… more
- Merck & Co. (Rahway, NJ)
- …results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial ... writers and specialists, engage in external activities to align the company with regulatory changes, act as the point of contact for external inquiries related to… more
- Merck & Co. (Rahway, NJ)
- …and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic ... practices.SAP Development DEV/OPSLead the SAP development team in delivering high- quality and efficient solutions.Define and enforce coding standards, development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change ... in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical...participation in a variety of cross functional CMC and quality forum under the Joint Manufacturing Committee in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …R&D PV QA organizational strategy. This position will proactively collaborate with other Global quality colleagues to drive the global QA vision and act as the US QA ... position will support continuous process improvement initiatives, support the annual Global Quality Strategy Plan for R&D PV QA and track business objectives through… more
- Merck & Co. (Rahway, NJ)
- …develop a breadth of experience including finance, accounting, analytics, risk management, and special project opportunities.Corporate Audit and Assurance Services ... allow individuals to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our global business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... in the clinical trials and translation of these findings into a benefit- risk profile. Relationships This position reports to the Corporate Project Vice President… more
