- Merck & Co. (North Wales, PA)
- …and final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the ... agencies for multiple indications simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization. It also plays a pivotal role in coordinating local activities with global monitoring functions, in support of Novo Nordisk's overarching global ... and compliance network within the industry. Partners closely with NNI and Global IT functions. Essential Functions Designs and provides strategic direction and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs, finance, NNGlobal, and other relevant entities to develop brand ... coordination brand leads. Essential Functions Integrated Portfolio Strategic Planning o Lead the development and operationalization of the Brand portfolio strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... process for Novo Nordisk's top PBM/payer accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes pre-deal… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and ... and disseminate educational materials and initiatives related to quality concepts across global teams. Lead and inspire cross-functional QA teams to implement… more
- Merck & Co. (North Wales, PA)
- …IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, ... with Health Authorities to promote harmonization and adoption of global standards around regulatory data management practices...local SOPs- - Data Centric Business System Owner Operations: Lead the regulatory data governance and standards… 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 ... immune disorders. SummaryThe Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists… 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 ... of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio.… 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
- 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 ... of laboratory data deliverables to support drug development processes and global submissions. This position provides leadership within Data Management by partnering… 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
- 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 ... this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness.- Lead internal and external (especially regulatory , but also expert… more
- Merck & Co. (North Wales, PA)
- …and adherence to our Policies, Rulebook Standards, and Specifications.Monitor the evolving global regulatory landscape, including tracking and analyzing new data ... lawmakers on industry best practices and requirements for effective global clinical research.Co- lead our network of 250+ Global Privacy Stewards who… 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 ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development ... 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
- 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 ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
