- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- …Research and Development (ARD)-at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation ... closely with other analytical groups in ARD , Global Quality and Regulatory Affairs -CMC to ensure that validated methods are appropriately transferred from our… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Scientist - Residual Assays, Analytical R&D We invite individuals who possess a deep passion for promoting lifesaving ... individual to join our Rahway, NJ team as a Senior Scientist (R3) in Biologics Analytical Research...Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical challenges,… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... with talented and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist ) has primary responsibility for… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist ) has primary responsibility for the planning and directing of… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist )...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior … more
- Merck & Co. (Rahway, NJ)
- …may:Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Clinical Director (Principal Scientist ) has primary responsibility for planning and directing clinical research activities involving… more
- Organon & Co. (Lansdale, PA)
- …Chemistry, Manufacturing and Controls (CMC) New Products, the Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls ... products including biosimilars in accordance with global regulations, guidances and defined regulatory strategies. The Senior Scientist is responsible for… more
- ThermoFisher Scientific (Wilmington, NC)
- …that people and communities depend on - now and in the future. The Senior Research Scientist (SRS), serves as the responsible person for strategic consultation, ... ensure flawless project execution. The SRS, will also be responsible for senior oversight of project design, protocol and final study report development, including… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Senior Scientist - Residual Assays, Analytical R&D** We invite individuals who possess a deep passion for ... individual to join our Rahway, NJ team as a Senior Scientist (R3) in Biologics Analytical Research...Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical challenges, provide… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... talented and dedicated colleagues while developing and expanding your career. The Senior Director (Sr. Principal Scientist ) has primary responsibility for the… more
- Kelly Services (Grand Rapids, MI)
- ** Senior Food Scientist (Dry Mix) - Grand...relevant food laws and standards. + Work closely with regulatory affairs teams to navigate regulatory ... MI** Kelly(R) Science & Clinical is currently recruiting for two qualified, permanent Senior Food Scientists for the Research and Development team for one of our… more
- Merck (Rahway, NJ)
- …Research and Development (ARD) at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation & ... closely with other analytical groups in ARD , Global Quality and Regulatory Affairs -CMC to ensure that validated methods are appropriately transferred from our… more
- AbbVie (North Chicago, IL)
- …disciplines to further program goals via collaborations with drug product development, regulatory affairs , and commercial operations. + The candidate will ... development of AbbVie's clinical candidates. We are seeking a Principal Research Scientist II to conduct process research and development of antibody-drug conjugates… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. We are seeking an Advisor/ Senior Advisor for Global Regulatory Affairs CMC to be a part of ... support for Clinical Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will… more
- Pfizer (Lake Forest, IL)
- …as appropriate working with Clinical Affairs Lead, Medical/Scientific Affairs Lead and Partner representatives. + Influences management/ senior management ... **ROLE SUMMARY** The Clinician, Clinical Scientist (CS) will provide leadership in clinical epidemiological...at relevant team, governance, external consultants, KOL and potentially regulatory meetings. + Represents Vaccine Clinical Affairs … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Abbott (Pleasanton, CA)
- …+ Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality ... to restore their health and live full lives. The ** Senior Clinical Research Scientist ** is a member... regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
