- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence function, responsible for driving...standards specific to GRA, in line with corporate data policy .Collaborate with cross-functional stakeholders (incl. RD / Corporate teams)… more
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, ... a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing… more
- Eisai, Inc (Nutley, NJ)
- …in alignment with IT security strategy. Prepares security reports to regulatory agencies. Audits and manages access management. Job Responsibilities: Architect and ... scalable security architecture that aligns with industry best practices, regulatory requirements, and organizational goals. Develop, implement, and enforce… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Alzheimer's Disease - Site of Care Marketing will assist with the development and ... project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise and input… more
- Merck & Co. (North Wales, PA)
- …support of clinical trial objectives.Core Skills Working knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multi e competing ... in life sciences, preferred.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to… more
- Merck & Co. (Durham, NC)
- …of inclusion, feedback and empowerment.Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.Ability to read ... Directing, Control, Decision Making-NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to… more
- Merck & Co. (Irving, TX)
- …and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and ... in English and Spanish#EBRGNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and review marketing application submission documentsAt the Director's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and company trade association group ... around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan… more
- Insmed Incorporated (San Diego, CA)
- …QC database. Set up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well as prioritize tasks ... and inspection standards, keeping the laboratory in compliance with regulatory standards.Coordinate inventory monitoring, sample, tests to perform and manages… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... only technology vendor partners, but with Manufacturing, Process Development, Quality, and Regulatory to ensure approval of the selected platform. The candidate will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Compliance organization and will report directly to the Director, Compliance Training, Policy & Communications. This position will be responsible for creating and ... business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...knowledge of cell therapy process preferred Experience in cGMP regulatory body audits Strong interpersonal and written/oral communication skills… more
- Merck & Co. (Rahway, NJ)
- …action development plans of personnel under their direction within the framework of Company policy . The Executive Director will be a manager of managers, with ... Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our… more
- Novo Nordisk Inc. (Chicago, IL)
- …understanding of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Identifies ... of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Continuously… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Merck & Co. (North Wales, PA)
- …Description: Senior Specialist, Project Management- Drug Development The Senior Specialist, Project Manager is a core member of Early Drug Development and/or Late ... independently or moderate-complexity assignments in conjunction with a partner project manager . Projects could span any therapeutic areas in which our company… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of ... our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late Drug Development… more
- Merck & Co. (Durham, NC)
- …guided by policies, procedures and business plan; receives guidance from manager .Manage multiple priorities and advance several tasks in parallel.Must be flexible ... systems.Minimum four (4) years of experience and familiarity of regulatory requirements in accordance with GMP manufacturing operations.Experience working in… more
- National Gypsum (Charlotte, NC)
- NG Corporate, LLC has an immediate opening for a Manager , Retirement Plan Administrator at our Charlotte, NC Headquarters location. This position will report to the ... VP, Human Resources. Job Summary: The Manager , Retirement Plan Administrator will be responsible for the strategic planning, administration, and compliance of the… more
