- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … 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)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, an Associate Principal Scientist /Associate Director, has primary responsibility for planning/managing real world and ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist /Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Malcom Randall Department of Veterans Affairs Medical Center (Jacksonville, FL)
- …technical procedures, providing technical instruction, ensuring that policies, procedures and regulatory requirements are followed, advising on course of action to ... vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Applicants pending the completion of… more
- CW Bill Young Department of Veterans Affairs Medical Center (Cape Coral, FL)
- …orientation, training, and competency assessment of staff to meet regulatory requirements. Implements and monitors quality management activities. Provides corrective ... vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Basic Requirements United States Citizenship:… more
- VA Northern California Health Care System (Mather, CA)
- Summary The Clinical Laboratory Scientist is responsible for evaluating, performing, interpreting, and validating the accuracy and validity of test results. ... vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Non-certified applicants who otherwise meet… more
- Boehringer Ingelheim Pharmaceuticals, Inc (Ridgefield, CT)
- …Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs , Patient Safety and Pharmacovigilance to implement ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
- Johnson and Johnson (Irvine, CA)
- …Description: Johnson and Johnson is currently seeking a Staff Clinical Research Scientist to support the scientific publication medical writing needs of the ... health for humanity. Learn more at https://www.jnj.com/. The Staff Clinical Research Scientist will join the Clinical Science & External Research (CSER) Team… more
- Exponent Inc. (Washington, DC)
- …responsible for Providing technical expertise to our clients related to food science, regulatory affairs , product approvals (GRAS, FAP, AAFCO, novel foods ... is to engage multidisciplinary teams of science, engineering, and regulatory experts to empower clients with solutions that create...Our Opportunity We are currently seeking a Senior Food Scientist for a Senior Manager or Principal level position… more
- Bio-Rad Laboratories, Inc. (Hercules, CA)
- As a Senior Staff Scientist . you`ll be right at the forefront of Bio-Rad's Clinical Diagnostics R&D Group - leading the design and validation of clinical diagnostics ... coordination and execution of design validation studies in collaboration with clinical affairs , human factors, R&D, marketing and sales specialists to gather user… more
- Barrington James (New York, NY)
- …Collaboration Work closely with Translational Medicine, Biomarkers, Clinical Operations, and Regulatory Affairs teams to ensure seamless execution of clinical ... assets from preclinical to clinical development. The ideal candidate is a physician- scientist or experienced clinical development leader with a strong background in… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- …will be essential *Interact with scientists, medical directors, and Technical Operations / Regulatory Affairs personnel for the timely completion of clinical ... our broad portfolio, we are seeking a highly motivated scientist to be responsible for designing clinical studies and...will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to… more
- UMass Memorial Health (Worcester, MA)
- …work indoors in a laboratory environment. ADDENDUM FOR MANAGER OF QUALITY AND REGULATORY AFFAIRS ROLE I. Position Summary: Responsible for leading a wide ... the use of quality improvement in daily operations. 8. Ensures compliance with regulatory agencies, including but not limited to: Joint Commission, DPH, CAP, CLIA,… more
- Montana VA Health Care System (Billings, MT)
- …for concepts, principles, methodology of medical laboratory technology, regulatory and accrediting agency requirements, medico-legal requirements, and pertinent ... practices require thorough understanding and adherence to all safety requirements as per regulatory laws such as used in phlebotomy, proper handling of blood and… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position** The Associate Principal Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) ... for the assigned portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals and organizational initiatives, on an… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral ... strategies and submissions for Lilly's commercial solid oral products. The regulatory scientist will be encouraged to demonstrate innovative regulatory… more
