- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader of the GRT ( Global Regulatory Team)The primary point of contact ... diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects....or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. 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)
- … education, and process development projects, as required. May serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global...multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical ... in and contribute significantly to professional organizations, academic or regulatory working teamsSuccessfully collaborate and lead resolution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the CMC working group leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the ADC/Bio#2 and an integral member of the ... and/or analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. 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)
- …on above product policy and political issues, working closely with the Executive Director , Global Policy and Multilateral Engagement and therapeutic area and ... Job DescriptionThe Executive Director , Policy Development and Strategy is a key...and Strategy is a key leadership role in the Global Public Policy Strategic Planning & External Engagement team,… more
- Merck & Co. (Rahway, NJ)
- …study execution, reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend ... Point, PA / Rahway, NJ is seeking a curious and collaborative Director to support our rapidly expanding cardiology respiratory, metabolism and ophthalmology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe role of Director , Global Communications, Oncology is a unique opportunity to join our company, a recognized leader in oncology, as a key ... for this role will work under the guidance of the Executive Director , Global Oncology Communications, in a fast-paced and ever-changing… more
- Merck & Co. (North Wales, PA)
- …and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical standardsCommercial lead in driving engaging presence ... Job DescriptionKey Responsibilities: Lead overall Scientific Strategy development and execution for Pneumococcal Vaccines FranchiseLead annual scientific strategy… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... research relevant duties under the RDPV QA functionMust have proven ability to lead and influence others within a global /matrix environment in the pharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally ... and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …creating business results with impact on VP/CVP level. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key...HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead (s), Global Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) or major ... 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)
- …Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... medicines to help people. 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)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on… 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 ... function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and… more
