- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Merck & Co. (North Wales, PA)
- … Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and ... with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our… more
- Merck & Co. (Rahway, NJ)
- …with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align ... Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) and/or… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... supplying 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)
- …and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with ... reports for the assigned product area, codes and enters information into the global safety database as requiredCreates and reviews individual and summary reports for… more
- Merck & Co. (Rahway, NJ)
- …to make decisions independently with limited oversight from Sr.COM or manager .Requires strong understanding of local regulatory environment.Ability to ... externally.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and… more
- Eisai, Inc (NJ)
- …reviewing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and ... 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.… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the ... hhc ).Represent the brand with internal and external stakeholders, including Global and Regional colleagues. Ensure appropriate strategic direction is communicated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Merck & Co. (Ames, IA)
- …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
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... of the team (eg documentation, housekeeping, area 5S, etc.)Participate in safety/ regulatory audits (ie tours, topic discussion)FinancialCoach the team to ensure SAP… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage inventory and expiry… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Merck & Co. (Millsboro, DE)
- …documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections ... eTime, Inspire.Compose, review, edit institutional SOPs.Serve as the hiring manager and trainer for Animal Services Managers.Coordinate promotions, transfers, or… more
- Merck & Co. (North Wales, PA)
- …Development organization at our company. Position Description/Summary 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. (Rahway, NJ)
- …and in the preparation of study documents for submission to regulatory agenciesExcellent verbal communication and presentation skills required; required to represent ... the group in internal meetings, in meetings with regulatory agencies and in scientific meetingsWorking knowledge of standard computer software applications for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Fidelity TalentSource LLC (Merrimack, NH)
- …Skills You Bring 3 years of financial services experience with an asset manager or custodian bank, preferably in mutual fund operations with exposure to Corporate ... excess of $1 billion at a given time. The Global Middle Office acts as a servicing center for...\u201Caccommodation\u201D to review Fidelity s Reasonable Accommodation for Disabilities Policy . To initiate a request for an accommodation, contact… more
