- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory ... areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as a member of the Global Project Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...discussion for archiving. Serve as the primary contact with FDA. Lead and prepare FDA submissions, including but not limited… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 serve as an...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences… more
- Merck & Co. (South San Francisco, CA)
- …company's Research Laboratories in South San Francisco is seeking an Associate Principal Scientist with strong expertise in translational cell models, mechanistic ... pharmacology, and biomarker and lead discovery to join our Quantitative Biosciences (Pharmacology) department. The successful candidate will be responsible for the… more
- Merck & Co. (North Wales, PA)
- …an important part for you to play:Put marketing strategy into action as you lead the development of our customer experience and campaign planning for our HPV ... marketing, you'll shape and orchestrate fully integrated digital campaigns and confidently lead our agency and internal teams through the creative process for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equal 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)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and… more
- Merck & Co. (Washington, DC)
- …on access, pricing/reimbursement, intellectual property, and trade policy Ability to . lead change management strategies, master complex policy, regulatory and ... Job DescriptionPosition Description: Associate Director, Policy Advocacy The Associate Director, Policy Advocacy serves as the senior expert in the Global Public… more
- Merck & Co. (Lower Gwynedd, PA)
- …developing and expanding your career.We are seeking a highly motivated Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics, ... our vaccines pipeline. The individual will be responsible to lead vaccine bioanalytical assay development, qualification/validation, technology transfer, and/or… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research… more
- Merck & Co. (Rahway, NJ)
- …execution of Phase 1-4 clinical studies. Under the direction of the Program Lead , you will collaborate with global, cross functional team members including clinical ... directors and study managers to lead /support clinical trial scientific activities.Job ResponsibilitiesResponsible for the clinical/scientific execution of clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for an Associate Director Global Oncology Marketing Hematology for a non-covalent inhibitor in Leukemia and Lymphoma.- A ... opportunity to help patients and expand our company's oncology hematology portfolio.The Associate Director of Global Oncology Marketing will report to the Hematology… more
- Merck & Co. (North Wales, PA)
- …are currently recruiting for someone to join our US marketing team as the Associate Director, Product Marketing Owner - HCC / Ecosystem for the HIV Franchise. -Ideal ... a significant launch. This is a dynamic opportunity for an experienced leader to lead a Customer Agile Team (CAT) while taking ownership of brand and HCC strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: ... strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision,… more
- Merck & Co. (Durham, NC)
- …peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. ... - The Lead Maintenance Technician is responsible for providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility… more
