- 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
- American Honda Motor Co Inc (Timmonsville, SC)
- …in order to execute objectives, keep timelines and ensure deliverables * Lead substance assessments for Mass Production products, perform reporting for external ... 2+ Years of experience required if degree in relevant fieldRequired Education: Associate 's degree in engineering or technical field Desired skills:Comprehension of… more
- Birchaven Village (Findlay, OH)
- …Birchaven Village ethical statement and resident rights, subject to the Associate Handbook. JOB DUTIES/RESPONSIBILITIES Duty 1: Demonstrates the knowledge and skill ... policies, procedures and practices to ensure quality job performance and regulatory compliance. Duty 10: Maintains communications with management regarding all… 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. (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. (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)
- …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. (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
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director, Alliance Management.Tris Pharma has a long track record of successful ... spanning many departments across all stages of the product lifecycle. The Associate Director, Alliance Management will be accountable for managing alliances of high… 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
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... driving change. Are you ready to make a difference? The Position The Associate Director, Process Chemistry will be responsible for the design, development and… 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. (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. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... & Ophthalmology Therapeutic Area. The incumbent will be expected to lead multiple ophthalmology programs including those new to the organization therefore… more
