- Merck & Co. (Rahway, NJ)
- …of clinical biomarker specimen collection, testing and data delivery activities in clinical studies . The primary focus of this position is in immunology, ... efficient delivery of the biomarker operational aspects of each study . This position will report into the Associate...as a co-author for drafting relevant biomarker sections of clinical study protocol Work closely with Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... Budget; Establishes effective communication between CRO / vendors / AROAdditional non- study related activities: Occasional senior management interactions at… more
- Aequor (Bothell, WA)
- …SUMMARY:The Downstream Process Development group in Bioprocess R&D is seeking a Senior Associate Scientist contractor to support development and optimization of ... processes for recombinant proteins and biological macromolecules for early- and late-phase clinical trials. The responsibilities of this position include but are not… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, ... vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or… more
- Merck & Co. (Rahway, NJ)
- …of clinical biomarker specimen collection, testing and data delivery activities in clinical studies . The primary focus of this position is in oncology, ... forwardParticipate as a co-author for drafting relevant biomarker sections of clinical study protocolWork closely with Translational Molecular Biomarker (TMB)… more
- Merck & Co. (Rahway, NJ)
- …Metabolism projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study ... development plans, and to ensure optimal trial design and monitoring of studies , producing high-quality clinical documents and presentations. The position… more
- Merck & Co. (Rahway, NJ)
- …simultaneouslyReview and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release ... Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs...single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Key Functions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and budget negotiations through understanding and tactics to develop, execute and deliver clinical studies /programs on time with a focus on budget, compliance ... you ready to make a difference? The Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management, Clinical Operations and other ... Effectively uses and communicates key findings and presents recommendations to Senior Regional and Global Finance Leaders.- Annual Portfolio Prioritization -… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates...product labeling as it relates to the use of study results in US promotion.Maintain current awareness of evolving… more