- ValSource, Inc. (Rahway, NJ)
- Project Manager ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management ... each of our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients and be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management system (Vault RIM). With direction from management works directly with Regulatory Project Managers to develop submission content project ... content and information is appropriately tracked, archived, searchable and accessible. Enters and tracks project and submission data in Regulatory Information… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy 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 OverviewThe MES Project Manager will be part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead… more
- Cipla (Fall River, MA)
- …the launch of Cipla's respiratory business in the United States. Job Title Project Manager Organization Name InvaGen Pharmaceuticals Location 7 Oser Avenue, ... Work Hours/ Shift/ Remote 8:30 AM - 5:00 PM Responsibilities/ Accountabilities The Project Manager position is a highly visible individual contributor role that… more
- Insmed Incorporated (NJ)
- …in. Are you?About the Role:Reporting to the Director of Technical Operations, Project Management this position will be responsible for leading life-cycle management ... timely completion and hand-off to routine commercial manufacture.What You'll Do: Lead project teams for Technical Operations activities, both within Insmed and with… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …success but rather the people we help along the way. ResponsibilitiesThe Facilities Project Manager will report to the Engineering, EHS & Facilities Department. ... facility. This role will oversee all phases of the project —from design through construction, commissioning, qualification, and operational handover—ensuring… more
- Merck & Co. (Rahway, NJ)
- …Administrative Professionals. Position Description/Summary: The GPAM Associate Director, Value & Implementation Project Manager (VIPM), is a core member of Value ... Project Management, Project Management Information Systems (PMIS), Project Planning, Publications Management, Regulatory Compliance, Risk Management,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition OverviewThe Project Manager , Patient Engagement works closely with the Scientific Patient Engagement & Advocacy Lead and is responsible ... Collaboration: Work closely with cross-functional teams (medical affairs, communications, regulatory , GEMs etc.) to ensure alignment and compliance in all… more
- Formation Bio (New York, NY)
- …Lead for clinical assets and associated studies. Step in as the Clinical Project Manager when needs arise. Operational Strategy and Leadership Develop and ... to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the… more
- Aequor (Thousand Oaks, CA)
- …management knowledge of full product manufacturing stages experience. The Supply Chain Project Manager (SCPM) will translate product variation strategy as ... This role will own the execution of the implementation plan in terms of project management and change control execution. This role will apply project management… 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
- 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 ... executing smaller improvement projects in their operational area- Represent Operations on project teams as needed- - Communication- Lead and support daily (Tier)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as Maximum Fair Price ("MFP") effectuation requirements consistent with regulatory requirements, NNI policies and procedures and Sarbanes-Oxley regulations. ... processes, oversee general management, and modifications in the event of regulatory changes. Supports analytics, good faith inquiries, complaints, and post payment… more
- Aequor (Basking Ridge, NJ)
- …needs, critical to managing the study needs. Ensure continuous re-assessment of Project needs as recruitment and the study progresses Sourcing of comparators and ... matching placebo as required on a Project by Project basis. Drive label generation...obtaining translations for all participating countries and the associated regulatory statements. Obtaining cross functional sign off on the… more
- BioAgilytix (San Diego, CA)
- …analysis.Write and review reports and prepare SOPs.Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients ... you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of… more
- Insmed Incorporated (NJ)
- …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 clinical ... start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol… more
- Insmed Incorporated (San Diego, CA)
- …management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated ... simultaneously. Coordinate and lead validation activities with internal stakeholders and project team members. Author CSV Documents (Validation Plans and Summary… more
- Merck & Co. (Durham, NC)
- …quality of raw materials, intermediates and finished products.Position Description: The Maintenance Manager at our Company's Durham facility is a leadership role and ... issues to minimize downtime and maintain product quality.Represent Maintenance on project teams as needed.Strong sponsor for the problem-solving efforts and… more
- Genmab (NJ)
- …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 ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Insmed Incorporated (NJ)
- …a validated state (eg SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated ... Summary Reports) Assist/co-author requirements, testing, specification, and other validation project deliverables Ensure training requirements are complete for … more
