- 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
- 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
- Merck & Co. (Durham, NC)
- …shift positions, 12.5 hour rotation (2-2-3). - - The role of Operations Manager at our Company's Durham drug substance manufacturing facility is a manufacturing ... employee development, routine 1:1 meetings and coaching, recognition, and performance management ). Additionally, they must become proficient in the use of… more
- Repligen (Waltham, MA)
- … Management (user provisioning, privileged access, segregation of duties) Change Management (system updates and configuration changes)IT Operations ... the design and operating effectiveness of ITGCs across Logical Access, Change Management , System Operations, and IT Governance.Conduct IT application… 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
- Merck & Co. (Rahway, NJ)
- …(RaDS) value team in our Company's R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... scientists' ability to discover and develop innovative medicines that change the course of human health. In the RaDS...enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position… 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
- Olympus Corporation of the Americas (Westborough, MA)
- …the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements and resource ... with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives. + A digital-native, change -embracing mindset, with a… more
- Insmed Incorporated (San Diego, CA)
- …and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews. ... and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory… 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
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