- Merck & Co. (Rahway, NJ)
- …approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single ... release from our company to external agencies and investigators.Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they… more
- Merck & Co. (Rahway, NJ)
- …approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single ... Scientist - Regulatory Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their...product labelingProvide expert advice as the Global Regulatory Lead to Product Development Teams… more
- Merck & Co. (Rahway, NJ)
- …and provides biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical, Regulatory, Statistical ... Job DescriptionPosition Description: Senior Principal Scientist , Biostatistics (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a distinguished… more
- Merck & Co. (Rahway, NJ)
- …and capability builds within the organization.Primary Responsibilities:Responsibilities: Lead development of new, innovative approaches for product ... them to pipeline assetsCollaborates effectively within and across functional areas to lead the development of novel drug delivery technologiesIs a recognized… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage ... Management (Signal identification, evaluation, mitigation):This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple… more
- Merck & Co. (Rahway, NJ)
- …Lead / contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of ... written communication skillsThe candidate should have a strong track record in product development / regulatory filing/ drug delivery/ complex formulation and… more
- Merck & Co. (Rahway, NJ)
- …vaccines and biologics.-- BDSC supports second generation process development and various commercialization activities including process characterization, process ... overall drug substance teams focusing on late-stage clinical process development , characterization, and technology transfer and validation with line-of-sight for… more
- Merck & Co. (North Wales, PA)
- …lead in the cross-functional teams for the strategic planning and execution for product development -Is involved in clinical development planning to ensure ... a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
- Aequor (Thousand Oaks, CA)
- …task execution, and co-leading regular core team meetings. Ensures that the product development process abides by all defined cross-functional standards, meets ... plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. - Provide deep technical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …group for dose escalation decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, ... About the Department Our Research & Development organization brings together the best minds in...of Senior Global Safety Lead (s), Global Safety Lead (s) and Global Safety Scientist (s)/Associate within Safety… more
