- Merck & Co. (Rahway, NJ)
- …Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support ... Labeling Therapeutic Area group is to drive labeling strategy and ensure high- quality and compliant labeling documents, which provide the safe and effective use… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the ... resolution.Proactively ensure that all functions consistently operate in a state of compliance .Facilitate the implementation of the quality strategy in close… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… more
- Merck & Co. (Rahway, NJ)
- …is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are ... achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in...Management (RCQM), and in collaboration with the Clinical Research Director (s), the Sr CCQM Lead establishes and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular basis and ensure actions are taken ... the oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional ... strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide....customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …direction and leadership for the investigations management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Merck & Co. (Durham, NC)
- …issues to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr . Specialist must ... and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for… more
- Merck & Co. (North Wales, PA)
- …Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices ... Responsibility Essential function(s) includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality… more
- Insmed Incorporated (Bridgewater, NJ)
- OverviewThe Senior Quality Engineer at Insmed position reports directly to the Director of Product Quality Complaints. The primary responsibilities ... product quality and customer satisfaction within the organization.ResponsibilitiesThe Senior Quality Engineer is responsible for managing Deviation/CAPA/EC… more
- Merck & Co. (Rahway, NJ)
- …related fieldRequired Experience and Skills: Minimum 7 years in Procurement, Compliance , Quality , Technology, Manufacturing/Operations, Supply Chain or related ... Job DescriptionPosition Description: Associate Director , SD&PM Third Party Risk Systems & Governance Supplier Development & Performance Management (SD&PM)… more
- Merck & Co. (Rahway, NJ)
- …and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular basis and ensure actions are taken ... the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey.… more
- Merck & Co. (Rahway, NJ)
- …support investigations and provide expert opinions or technical assistance as needed. Quality Assurance and Compliance :-Develop and implement protocols and ... Job DescriptionAssociate Director - Digital Forensics Position Summary:-We are seeking...lab, ensuring all activities are conducted efficiently and in compliance with legal and regulatory requirements. Manage and provide… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the ... and functional service providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team. The ideal individual… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …relationships include various interactions with customer Executives, Medical, Pharmacy, Quality , Health Economics and other key personnel, organizations and ... This includes the execution of brand value propositions, including clinical, quality and health economics positioning and product specifications Direct/oversee the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDescription:The Senior Principal Scientist reports to the Senior Director Chemical Biotechnologies of Process Research & Development Enabling ... and Scope of Position: This role reports to the Senior Director of Chemical Biotechnologies within Enabling...activities are completed with the highest regard for safety, quality and regulatory compliance . Qualifications: Education Minimum… more
- Insmed Incorporated (Bridgewater, NJ)
- …has been created to support Insmed's Information Technology increased project and quality delivery demands, and recognized as aa strategic imperative to deliver on ... methods across all of Information Technology. Reporting to the Director of IT Program Management, this dually focused role...disciplines by: a) performing the duties of a trusted senior project manager and b) jointly developing project delivery… more
