- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:We're looking for a Manager , Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs ... for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs, Tactical Implementation, you'll have a critical role in hands-on… more
- 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
- Aptyx (Charlotte, NC)
- Project Manager (PM) is responsible for...with Aptyx's core values, and in compliance with applicable regulatory requirements. The primary goal of the PM is ... a range of internal and external stakeholders, most often managing several moving project parts simultaneously. The PM role is responsible to plan and designate … 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
- Merck & Co. (Rahway, NJ)
- …Informatica Metadata Manager , Management Process, Process Flow Documentation, Project Management, Regulatory Documents, SAP Master Data Governance (MDG), ... and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… 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
- 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
- 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
- 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
- Genscript USA Inc. (Piscataway, NJ)
- …Develop and deliver EHS training programs for site staff, contractors, and project teams. Support permit applications and regulatory reporting. Lead site ... Job Overview: GenScript is seeking a proactive and experienced EHS Manager to oversee all environmental, health, and safety activities at our Piscataway, New Jersey… 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
- 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
- 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
- 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
- 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
- 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
- Lifeway Mobility Holdings LLC (Detroit, MI)
- Position Title: General Manager with HME Sales Expertise Location: Detroit, MI, USA Req. ID: 189 General Manager - Sales Driven Leader to expand into Detroit ... and independence in the home. As a Selling General Manager , you will lead your team to earn 5-star...in-home mobility products. Operations Responsibilities: Review each sale and project to confirm quality standards of product, installation and… more
- Syner-G BioPharma Group (Boston, MA)
- …strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, ... phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in...sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, ... including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed The SDL will… more
- Cipla (Fall River, MA)
- …- 5:00PM (may vary based on business needs) Reports To : Manufacturing Manager Salary Range: $62,400 - $75,400 Purpose: The content and statements documented in ... is responsible for the creation and revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role… more
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