- 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...related to US/Ex-US regulatory submissions. In addition, this individual will be responsible… more
- Merck & Co. (Rahway, NJ)
- …Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality ... HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... operations team for the site.- The Manager will direct a team of hourly personnel who...plant maintenance and spare parts procurement systems.Working knowledge of regulatory requirements in accordance with GMPs.Ability to work in… 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
- 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, ... change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady supply… 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
- 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
- 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
- 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
- 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. (Durham, NC)
- …for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates ... and finished products. Our Company is expanding its global human papillomavirus (HPV) vaccine production for Vaccine Manufacturing in Durham, NC. The new facility… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams (eg, marketing, sales, research and development, market access and policy /advocacy (MAPA), finance, operations, global , etc.) to streamline processes ... to achieve launch milestones and objectives. Works cross functionally with the global team to ensure launch measurements and governance reviews are on track… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …2 years of work experience in Pharma in job offered or as Product Manager / Global Delivery Lead. Also requires 2 years of leadership experience with/using the ... following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes… 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
- 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
- DCS Corp (Bedford, MA)
- DCS Corp has an exciting opportunity for a Principal Program Manager within our AFLCMC/HBG group! The C2ISR Division is responsible for a diverse portfolio that ... financial planning and budgeting, security, flight test, and contracting functions. The Global Network Systems (GNS) Branch (AFLCMC/ HBGW), located at Hanscom AFB,… more
