- Merck & Co. (Rahway, NJ)
- … Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... projects and teams as assigned.Key Accountabilities:Directs activities of the General Medicine global regulatory therapeutic area and team leading to global… more
- Merck & Co. (Rahway, NJ)
- …global medical communications processes, and demonstrated ability to lead and implement large-scale transformation initiatives1.Prior experience working across ... Job DescriptionThe Director, Global Scientific and Value Content-Healthcare Professional (Dir GSVC-HCP)...role reports directly to the Therapeutic Area (TA) Team Lead , GSVC. The role has several key responsibilities with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Product Security Lead Designer, you will play a pivotal role in shaping the security landscape of our organization. Your primary ... responsibilities will include:Designing Security Controls: Lead the design and implementation of innovative and robust security controls across various domains… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore requiring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... 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
- Eisai, Inc (Nutley, NJ)
- …of staff. Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under...cycle management of existing products. May serve as the lead regulatory representative on the project team… more
- Formation Bio (New York, NY)
- …biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC ... manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional teams and… more
- Eisai, Inc (Nutley, NJ)
- …reports, education, and needs.Essential Functions Advance Medical and Scientific Knowledge of the Global Medical Team (45%) Lead Global MSL continuing ... statistics, etc.) to supplement MSL development.Collaborate with Digital Strategy & Innovation lead on global MSL insights sharing forums. Collate, prepare, and… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers… more
- Merck & Co. (Rahway, NJ)
- …and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of ... Duties and Responsibilities: The Specialist will become knowledgeable in regulatory requirements, cGMPs and our Company's procedures to assure clinical… more
- Merck & Co. (Rahway, NJ)
- …and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cost savings, and deliver measurable value through sourcing excellence.Key Responsibilities Lead and support implementation of a Global Sourcing organization ... Legend Biotech is a global biotechnology company dedicated to treating, and one...update risk score of all BOM and other high-risk Materials. Lead development of Sourcing Score Boards, KPIs and other… more
- Merck & Co. (Rahway, NJ)
- …innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and ... the Director of the Raw Materials and Medical Devices/Combination Products (MDCP) will lead a team of specialists and scientists in Rahway supporting raw material,… more
- Merck & Co. (Rahway, NJ)
- …with experienced supervisors who provide valuable guidance while you lead projects from conception to implementation. Primary responsibilitiesLead the development ... related to secondary and tertiary packaging.Develop working relationships with global company functions, external manufacturing and third-party distribution centers,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... quality deliverables are on time to support drug development processes and global submissions. This position also partners with internal and external stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness. Lead internal and external (especially regulatory , but also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to lead an efficient and effective organization Support the global quality annual objectives, strategic initiatives to deliver against the business plan.In ... 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)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply:… more
