- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project (s).Strategize and plan… more
- Merck & Co. (Rahway, NJ)
- …Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... in GRACS for business process management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Outcomes Research Marketing and Market development, as well as Global Medical Affairs . Essential Functions Lead projects, representing Medical Affairs ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Medical Affairs Postdoctoral Fellowship is a one-year, experiential program based… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …performing Global roles in the United States (such as Global Marketing, Global Medical Affairs ). For these areas, acts as lead attorney for that area providing ... Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to,… more
- Merck & Co. (Rahway, NJ)
- …learn new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements. The ability to multi-task, work independently, ... database standards, SOPs, and Process Guidelines. You will have the opportunity to lead and participate in the review of electronic case report forms (eCRF) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project ... include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry experience (including roles in research and development (R&D), clinical trials, regulatory affairs , or medical affairs Leadership Experience: Proven ... East Coast Hub. The Vice President is expected to lead a team of leaders to ensure innovative development...markets and business needs and leverage medical, scientific and regulatory opportunities. In agreement with the individual Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs ' ... operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... Provide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …knowledge and knowledge of the region to enhance territory management of field teams Lead project teams to manage and support various projects such as digital ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...This position may report into the Field Director, Medical Affairs (or in smaller TA's directly into the TA… more
- Eisai, Inc (Nutley, NJ)
- …products, interfaces with cross-functional teams including marketing, market access, and medical affairs to align strategies, and partners with HEOR field team in ... health economics and outcomes research strategies, timelines and budgets with medical affairs , marketing, market access and global value and access teams. Projects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …oversight and decision-making. Coordinate cross-functional collaboration among commercial teams, medical affairs , regulatory affairs , and other stakeholders ... pricing strategies, and lifecycle management tactics Lifecycle Management Strategy: Lead the development of comprehensive lifecycle management plans for each… more
- Aequor (Thousand Oaks, CA)
- …Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs . Job Responsibilities: Succinctly communicate verbally while ... occur with a Right-First-Time approach. Strong project management skills, with prior project experience a must Lead meetings with cross functional teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... that have high ROI Agency/Vendor management experience required Ability to lead and collaborate on cross-functional teams required Anticipates problems and… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Atlas Data Systems (Wilmington, DE)
- …to drive decision-making and optimize launch plans. Collaboration with marketing, sales, regulatory affairs , medical affairs , and other departments is ... We are seeking an experienced Senior Manager, Post Market Research, to lead and execute successful drug launches for top pharmaceutical clients. The ideal… more
