- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position The Specialist, Regulatory Operations - Submissions supports the development of submission plans created ... submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal departments 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
- Insmed Incorporated (NJ)
- …science, we're in. Are you?About the Role:Reporting to the Director of Technical Operations , Project Management this position will be responsible for leading ... timely completion and hand-off to routine commercial manufacture.What You'll Do: Lead project teams for Technical Operations activities, both within Insmed and… more
- Merck & Co. (Rahway, NJ)
- …and the operational/executional arms within the business.- - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.- - Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for ... clinical supplies. Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Insmed Incorporated (NJ)
- …start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol ... study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. Key global trial management support to the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Strategic Initiatives & Capacity Expansion Project Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at the cGMP Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position We are seeking a detail-oriented and passionate Training Manager to join our Clinical, Medical, Regulatory (CMR) group at Novo ... Functions Create job-specific training curricula for different roles within clinical operations , medical affairs, and regulatory affairs Maintain training… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …successful completion of major programs or initiatives, and may function in a project leadership role Regulatory Compliance: Ensures compliance with all Federal ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...appropriate Understands Patient Safety case processing and NNI contracting operations including tool and systems used, exceptions processes, and… more
- Merck & Co. (Durham, NC)
- …skills (instrumentation, electrical and mechanical Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations ... Effective maintenance, troubleshooting, and problem-solving skills Working knowledge of regulatory requirements in accordance with GMP manufacturing operations… more
- Eisai, Inc (Baltimore, MD)
- …and up to date. Coordinates outside calibrations/schedule with vendorsServes as project manager for projects and improvements.Ensures that all applicable ... ensure reliability and compliance with company standards and governmental regulatory requirements. Investigates/troubleshoots equipment/instrument issues and/or performance processes. Ensures… 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...is at an exempt level working within the Technical Operations team. This individual will be responsible for managing… 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
- Cipla (Fall River, MA)
- …5:00PM (may vary based on business needs) Reports To : Quality Assurance Manager Salary Range: $72,800 - $93,600 Purpose: The QA operation specialist (MDI) position ... for shop floor QA Associates. Complete other duties or participate in project work as assigned by management. Education and Experience Advanced vocational training… more
- Insmed Incorporated (NJ)
- …Programming will be working interactively with functional colleagues from Biostatistics, Clinical Operations , Data Management and Project Management, as well as ... for the future of science, we're in. Are you?About the Role:The Manager , Programming will provide statistical programming and analytic support clinical studies. As… more
- Cipla (Hauppauge, NY)
- … operations comply with Good Manufacturing Practices (GMP) and regulatory requirements. Participate in internal audits and ensure compliance with warehouse ... the quality and compliance of printed packaging materials and warehouse operations . This includes reviewing and approving artwork, maintaining accurate artwork… more
- Merck & Co. (North Wales, PA)
- …Product Line Lead, Software engineers, Architects, UX designers, Business Analyst, Technical Project Manager , Service Line Lead, other Product Managers, Vendors ... of our software products in the clinical domain.The Product Manager in this role should be able to define...solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and colleagues.As a… more
