- Daiichi Sankyo, Inc. (Bernards, NJ)
- … product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.Collaborate ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as developing activity plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by working with ... and an integral member of the decision making in the Project lead .ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC product level strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and… more
- Merck & Co. (North Wales, PA)
- … statistician in cross-functional teams for the strategic planning and execution for product development and worldwide regulatory submissions. Lead a team of ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will ... area objectives. Relationships Reports to the Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including sales, marketing, medical… more
- Merck & Co. (North Wales, PA)
- …Global Marketing, Data & Analytics, Policy, Payer Marketing, Global Communications, Regulatory , Legal/Compliance Partner with other Product Marketing Owners to ... join our US marketing team as the Associate Director, Product Marketing Owner - HCC / Ecosystem for the...is a dynamic opportunity for an experienced leader to lead a Customer Agile Team (CAT) while taking ownership… more
- Merck & Co. (Durham, NC)
- …commissioning and qualification, licensure, and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong interpersonal, ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position The therapeutic area Operations Lead is responsible for supporting the therapeutic area One Impact Planning process, ... the business. Relationships Reports to the US Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including sales, marketing, medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Customer Experience Lead will play a crucial role in ensuring the success of our field teams by ... to drive results. Relationships Reports to the Integrated TA Strategy Lead . Collaborates with sales and market access and policy/advocacy (MAPA) leadership… more
- Merck & Co. (Durham, NC)
- …peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. ... - The Lead Maintenance Technician is responsible for providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … more
- Merck & Co. (Rahway, NJ)
- …join our Large Molecule Analytical Validation team to serve as an Analytical Program- Lead . The lead must take charge in overseeing and guiding analytical ... across all workstreams, and proactively mitigate challenges that may arise. The lead will maintain program schedules diligently while escalating any identified risks… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Investigations Lead (1st or 2nd shifts) as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Scientist, Microbiology (Lab Lead ) - Analytical Research & Development (Onsite) Small Molecule Analytical Research and ... in a GMP environmentKnowledge and experience with manufacturing and GMP product testingExperience in leading and supporting quality investigations and change… more
- Merck & Co. (Durham, NC)
- …in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The ... Lead Maintenance Technician is responsible for providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background ... microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team… more
- Eisai, Inc (Nutley, NJ)
- …align communications and strategies across the brand's target audiences and to ensure regulatory /legal requirements are met. The SPM will lead efforts on ... If this is your profile, we want to hear from you. The Sr. Product Manager (SPM), US Oncology Women's Cancer, is responsible for contributing to the strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting the ... manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through building positive relationships… more
