- Merck & Co. (Rahway, NJ)
- …market authorization, execute of post marketing commitments and meet compliance obligations.Qualifications and Skills:Required: Global Regulatory experience ... will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS)...implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory … more
- Merck & Co. (Upper Gwynedd, PA)
- … success together with risk mitigation measures.-Lead development and execution of global product and project regulatory strategy(ies) by ensuring ... robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of… more
- Merck & Co. (Rahway, NJ)
- …readiness across the network to ensure sustainability and scalability of future product launches.The Head, Global Biologics Network Launch Readiness will:Lead ... Job DescriptionOur Global Biologics Operations (GBO) organization is responsible for manufacturing and supplying commercial biologic products that support over $30… more
- Merck & Co. (Rahway, NJ)
- …participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... Immunochemistry, People Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design of… more
- Twist BioScience (South San Francisco, CA)
- …SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements and ... The Regulatory Operations Specialist is responsible for ensuring the...Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. Collaborate with cross-functional… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution… more
- Merck & Co. (North Wales, PA)
- …Integration, Operational Excellence, Oral Communications, Pharmaceutical Management, Product Registrations, Professional Networking, Project Management, ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle… more
- Merck & Co. (Rahway, NJ)
- …global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirementsActively participate ... Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance , Regulatory Inspections, Vaccine… more
- Merck & Co. (Rahway, NJ)
- …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual...management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for.... The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline… more
- Merck & Co. (Omaha, NE)
- …show free goods, facilitate transfers between countriesMaintain order status, customer, product specifics and compliance databasesEnter data, monitor order ... closely with freight forwarders, QA departments, USDA and other regulatory officers. Provide data to the Finance department so...status for adequate supply of product to fill ordersMaintain compliance on export… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a… more
- Merck & Co. (Millsboro, DE)
- …Operations, Manufacturing Quality Control, Media Preparation, Process Improvements, Regulatory Compliance , Safety Practices, Science, Standard Operating ... We work in the local plant linked to our global manufacturing network to ensure the highest quality of...classes, workshops, meetings, etc., to improve job skills and product -related procedures.-Some duties may include but are not limited… more
- Merck & Co. (North Wales, PA)
- …to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective ... epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams, Regional Product Directors,… 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
- Insmed Incorporated (San Diego, CA)
- …of calibration and maintenance systems to ensure operational readiness and regulatory compliance . Responsibilities include leading the procurement, installation, ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...opportunities for productivity improvements.Develop and execute C&Q plans in compliance with internal procedures and regulatory standards.Lead… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full c ompany's ... meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have...Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address… more
- Insmed Incorporated (San Diego, CA)
- …transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage research through commercial launch. Involves… more
