- 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. (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 ... a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and company trade association group ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …to develop your leadership and technical skills as part of a global , cross-functional team . You will apply project management, communication, and collaboration ... support of clinical trial objectives. Core Skills Working knowledge of clinical research regulatory requirements (eg . , GCP and ICH) Ability to manage multiple… 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 ... within the research world.Communicate between various Internal departments such as Global , R&D, business development and marketing to improve innovation pipeline,… more
- Legend Biotech USA, Inc. (NC)
- 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. (North Wales, PA)
- …to-demonstrate your leadership and technical skills as part of a global , cross-functional team. You will apply project management, communication, and collaboration ... any study specific partners and/or vendors.Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in Raritan, NJ. Role Overview This position represents a critical ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...vendor partners, but with Manufacturing, Process Development, Quality, and Regulatory to ensure approval of the selected platform. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regional and global training modules; annual update of regional and global training modules, etc. Policy assist with the drafting of non-GxP policies and ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionAbout Insmed Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. ... 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… 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
- 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. (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
- 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)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates ... studies.-Under the direction of the Program Lead, you will collaborate with global , cross- functional team-members including clinical directors and study managers to… 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
- 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
- HSBC (New York, NY)
- …however qualified candidates based outside of the New York City area may be considered. As our Manager Global Regulatory Policy you will: + Track new ... our people, our investors, our communities and the planet we all share. Global Regulatory Policy & Advisory ('GRPA') is responsible for establishing HSBC's… more
