- Novo Nordisk Inc. (Plainsboro, NJ)
- … Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of Individual Case Safety Reports and other safety reports ... the locations. Collaborate with the other departments within Patient Safety organization, CMR, outside of CMR, and Global...Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science 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
- Merck & Co. (Rahway, NJ)
- …leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of ... the Director Packaging Distribution, Components and Systems COE, the Director, Global Distribution Engineering and Technology, will be responsible and accountable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within Intake and Triage, Medical Review, Submissions and Compliance, Global Safety , and centralized teams (eg, Training and Documentation, Quality, ... Works with Vendor leadership and hub leadership teams. Works closely patient safety leadership team members in Data Acquisition, Medical Review, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including activities related to evidence generation, scientific engagement and communication- Serves as Global Medical Affairs Team (GMAT) Lead , to gain ... the portfolio of early asset compounds under the supervision and leadership of the Global Medical Affairs (GMA) Franchise Head. Develops the GMA early strategy… more
- Insmed Incorporated (NJ)
- …the organization.What You'll Do: As Insmed's Director of Environmental Health & Safety (EH&S), the individual will lead the development, implementation, and ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...healthy, safe, and compliant workplace for all employees.Chair and Lead Quarterly Safety Committee meetings at each… more
- Merck & Co. (Rahway, NJ)
- …Development Digital Solutions (CDDS IT), the Executive Director, Digital Regulatory and Safety , will lead our efforts in transforming regulatory submissions and ... Develop and promote a multiyear product strategy for Digital Regulatory & Safety , aligning with IT and Research and Development (R&D) priorities, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated ... commercialization). Responsibilities:Depending on the status of development of the compound, lead and medical -scientifically direct a team of physicians and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical ... and drive initiatives for continuous quality improvement.Deputize for the Sr. Director, Medical Affairs QA as needed. Cross-functional and Global Team… more
- Insmed Incorporated (NJ)
- …registries. Lead and execute on innovative omnichannel medial education.Provide medical expertise into the marketing strategies for the asset.Provide review of ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...Medical Education in compliance with internal processes.Provide strategic medical support to Drug Safety for any… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, ... documents (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety , Regulatory Affairs, Epidemiology) to ensure benefit-risk… more
- Merck & Co. (North Wales, PA)
- …for future leadership roles.Key Responsibilities include, but are not limited to:HCP Strategy: Lead a cross-functional team ( Global , HHDDA, RDMA, and others) to ... to measure pre-launch and launch readiness.Academic Center and Integrated account Strategy: Lead a cross-functional team ( Global , HHDDA, RDMA, and others) to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …recommendations to management and lead implementation of solutions May collaborate with Global Safety to align on case handling instructions across safety ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...LT member. Collaborates with the other departments within Patient Safety organization and Global Patient Safety… more
- Merck & Co. (North Wales, PA)
- …applications.Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead .Participating as an active member on the ... and competitive intelligence to facilitate development of regulatory strategy.Assisting the global regulatory lead in authoring of regulatory strategy… more
- Merck & Co. (Durham, NC)
- …therapies for our patients. We work in the manufacturing plants with a " Safety First, Quality Always" mindset, striving for continuous improvement, and earning our ... right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished… more
- Merck & Co. (Durham, NC)
- …schedules project/work meeting the criteria established by site objectives. Support & lead Utility equipment related projects, scope including but not limited to ... support and training to mechanics and other maintenance personnel. Interface with safety , production, and quality groups to ensure facility operations and systems… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Security Operations - Americas. Will support the Advanced Security Operations function lead by the Director Global Security Operations - EMEA as a ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Merck & Co. (Rahway, NJ)
- …automation systems in a validated, compliant state per cGMP, Safety , data integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, ... automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as part of Launch Readiness activities and life cycle management from a medical perspective- Participates in Global Medical Affairs committees as ... requested. Serves as US Medical Affairs Lead , to gain strategic and planning alignment across the...US IIS Review Committee, for assigned compound. Collaborates with Global Medical Affairs and across USOMA functions… more
