- Merck & Co. (Rahway, NJ)
- … Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... projects and teams as assigned.Key Accountabilities:Directs activities of the General Medicine global regulatory therapeutic area and team leading to global… more
- Merck & Co. (Rahway, NJ)
- …of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global product and project regulatory ... strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability… more
- Merck & Co. (Rahway, NJ)
- …to ensure sustainability and scalability of future product launches.The Head, Global Biologics Network Launch Readiness will: Lead and manage cross-functional ... and lead a cross-functional launch readiness governance model across global sites and functions.Build and chair a global launch readiness… more
- Merck & Co. (Rahway, NJ)
- …ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions. Lead the ... in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore requiring… 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 Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Merck & Co. (Rahway, NJ)
- …from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact ... ensure they are developed and manufactured in accordance with regulatory , company, and customer requirements.- -Principal ResponsibilitiesLead/contribute to device… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide ... point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the… more
- Merck & Co. (Rahway, NJ)
- …focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide… more
- Merck & Co. (Rahway, NJ)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Merck & Co. (Rahway, NJ)
- …leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of ... clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring… more
- Merck & Co. (Rahway, NJ)
- …up to $5M across all our company's divisions; - Manufacturing division, Global Workspace and Enterprise Services (GWES) and our research laboratories, Global ... the liaison between the sites and ultimately to the Global Cap Ex team, ensuring the correct sourcing and...capital project to ensure upfront alignment on the sourcing strategy. Lead sourcing projects to deliver optimal value to the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Merck & Co. (Rahway, NJ)
- …your leadership, technical skills, and scientific acumen as part of a global , cross-functional team . - Job Responsibilities - Responsible for leading specific ... clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading...clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and… more
- Merck & Co. (Rahway, NJ)
- …to demonstrate your leadership and technical skills as part of a global , cross-functional team. You will apply project management, communication, and collaboration ... execution of a clinical trial.May serve as the clinical trial team leadMay lead team in key study planning, development, and execution elements (eg, data management… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Merck & Co. (Rahway, NJ)
- …and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …to demonstrate your advanced leadership and technical skills as part of a global , cross-functional team. You will build and coach your team in the development ... conduct of clinical trial(s).Serves as the Clinical Trial Team lead . Leads and directs teams in key study planning,...This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply:… more
- Formation Bio (New York, NY)
- …biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC ... manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional teams and… more
