- 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)
- Job Title Project Manager Organization Name InvaGen Pharmaceuticals Location 7 Oser Avenue, Happauge NY 11788 Employment Type (Hourly/ Full Time) Full Time - ... 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. (North Wales, PA)
- …of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation ... Preparation and Management:The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development. Are you ready to realize your potential? The Position The Manager , Call Planning Operations manages the implementation and ongoing maintenance of ... compliant, strategic call planning for the Cardiometabolic sales organization. This...files are accurate, and distributed to downstream systems. The manager translates corporate objectives and sales strategies into actionable,… 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… more
- Merck & Co. (Durham, NC)
- …Site's Sustainability portfolio in its entirety involving any of the following: Regulatory compliance with internal interpretations Manage project strategy for ... Technical writing and deviation investigation experience Experience in managing a project portfolio and/or a program with strategic initiatives. Experience… 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 ... will include, but not necessarily limited to the following: Provide strategic leadership and decision making on CSV strategy Develop risk-based validation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of ... 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.… more
- Merck & Co. (Durham, NC)
- …Occupational Safety and Health, Process Improvement Projects, Productivity Improvements, Project Management, Regulatory Audits, Sterile Manufacturing, System ... by policies, procedures and business plan; receives guidance from manager .Provides technical guidance to employees, colleagues or contractorsAnticipates and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in English, operational leadership, and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience ... and close out) including timeline, and budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and extended team to… more
- Merck & Co. (Rahway, NJ)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:Solid knowledge of clinical… 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
- Eisai, Inc (Nutley, NJ)
- …different individuals, groups, or departments. Individual will partner with and receive strategic guidance from manager , but must be comfortable managing ... we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic , business-minded, and hands-on attorney role whose job will be to lead Eisai's… more
- Syner-G BioPharma Group (Boston, MA)
- COMPANY DESCRIPTION: Syner-G is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development ... supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We… more
- Parexel (Bismarck, ND)
- …treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, dedicated ... initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory... requirements. Project Management: Serve as the project manager for meetings, adhering to best… more
- Insmed Incorporated (NJ)
- …with serious diseases. In this role, you'll be reporting to the Sr. Manager , Clinical Supply Chain & Logistics.The Insmed Summer Internship Program is designed to ... and the intern will be assigned goals and objectives that will support the strategic business plan of the company.What You'll Do: In this role, you'll have the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes. Acting with agility and strategic foresight, ... 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… more
- Stony Brook University (St. James, NY)
- IT Project Manager **Position Summary** At Stony Brook Medicine, the IT Project Manager will be a member of the Stony Brook Medicine IT PMO Team and will ... all projects assigned to oversee. **Duties of an IT Project Manager may include the following but...all projects are consistent with overall customer objectives and strategic plans. + Manage the day-to-day activities of cross-functional… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the medical technology space. This role involves researching, recommending, and implementing regulatory best practices, contributing to both the strategic and ... exempt from the medical device classification, and connected technologies. + Provide regulatory guidance, compliance risk assessment, and strategic input to… more
- Stanford Health Care (Palo Alto, CA)
- …develop the leadership needs and internal capacity of the department and facilitates strategic changes in project scope or assignment across the team.- Coaches ... with the leadership team to improve services provided and assures compliance with regulatory requirements. + 2. Project Management and Execution- Defines … more