- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal ... actions items, risks, and decisions to the team. With direction from management , manages multiple regulatory submission projects, including the development of… 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 subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications Creates quality control ... regulations/guidance's Creates any needed documentation and training for standard processes, change control management and tools Responsible for defining… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the team to be effective.Strong track record in executing effective project management in cross-functional teams within IT, clinical, regulatory , pharmaceutical ... in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV ... of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.Detailed management and oversight of regional trial activities, as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Facility Support Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Facility Support Manager is at an exempt level working within the...space walkthroughs to ensure GMP compliance.Actively participate in all regulatory and internal audits of the facility.Participate in the… more
- Genmab (NJ)
- …developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious ... Then we would love to have you join us!The Senior Oncology Account Manager (OAM) for the Pittsburgh territory builds and maintains strong professional relationships… more
- Insmed Incorporated (NJ)
- … management and remain in a validated state (eg SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. \tEnsure compliance ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews.What… more
- Lundbeck (Toms River, NJ)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... on customer needs and organizational goals, incorporating "total office" account management where applicable. Local Market & Therapeutic Area Expertise - Gather… more
- Merck & Co. (Rahway, NJ)
- …Skills: Adaptability, Adaptability, Business Processes, Business Process Improvements, Change Management , Clinical Research, Cross-Functional Team Leadership, ... , Project Management Information Systems (PMIS), Project Planning, Publications Management , Regulatory Compliance, Risk Management , Sourcing and… more
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