- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Principal Scientist with expertise in microbial process development for the production ... biomolecules, including novel biotherapeutics, vaccines, and engineered enzymes.As a senior scientific leader, the successful candidate will shape strategy, drive… more
- Merck & Co. (Rahway, NJ)
- …Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Proper Documentation , Regulatory Compliance, Regulatory Requirements {+ 4 ... MES, SCADA, DCS, and OEM systems-Work with process development teams on technical development and the testing of new technologies, trialing new automation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Parexel (Trenton, NJ)
- …labeling expertise into strategic impact? We're seeking a sharp, detail-driven ** Senior /Consultant, Regulatory Labeling** to join a dedicated partnership with ... go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs, Technical Operations, Safety, and Commercial. You'll help… more
- GRAIL (Trenton, NJ)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor… more
- Insmed Incorporated (NJ)
- …of regulatory submissions including INDs, NDAs/MAAs, and other required documentation . Ensuring compliance with ICH, FDA, EMA, PMDA and other international ... for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and...activities for the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug… more
- Insmed Incorporated (NJ)
- …you?About the Role:The Director, EHS (Environmental, Health, and Safety) isa senior -level role responsible for creating and implementing programs that ensure ... workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key...audits and surveys, analyze results, and provide reports to senior management and other stakeholders.Advise senior leaders… more
- Tradeweb (Jersey City, NJ)
- …+ **Requirements & Delivery Oversight** : Lead the gathering, validation, and documentation of detailed requirements; review technical implementations to ensure ... We are seeking an experienced Senior Product Manager to join our Technology organization,...of trading systems and algorithms, ensuring all business and technical requirements are met and issues are resolved promptly.… more
- Insmed Incorporated (NJ)
- …role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, ... building and protecting secure digital environments. The ideal candidate combines deep technical expertise with a proven ability to communicate complex risks in… more
