- 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)
- …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
- 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 ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… 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)
- …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
- 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… 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 ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Merck & Co. (Rahway, NJ)
- …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)
- …Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive ... on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic...for the TA. This role also contributes to the global TA strategy by working closely with global… more
- Merck & Co. (Rahway, NJ)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional teams (eg, marketing, sales, research and development, finance, operations, global , etc.) to streamline processes and ensure smooth execution of ... 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. (Plainsboro, NJ)
- …message. Relationships Reports to Brand Lead or Consumer Strategy Lead . Collaborates with cross-functional and global Alzheimer's working teams, including ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, and other relevant NNI departments to ensure alignment of… more
