- Aequor (Thousand Oaks, CA)
- …for a candidate with skills to support the quality control/review of nonclinical scientific reports. Title: Associate Research Operations, Nonclinical Report QC ... role is responsible for the quality control (QC) of nonclinical reports generated by the scientific staff in TS&BA...Metabolism (PKDM) groups. This role will provide oversight of nonclinical report QC, contribute to data integrity review of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for submissions, eg, clinical protocols and study reports, ... preclinical reports, investigator brochures, application summary documents, etc. Research and analyze the evolving competitive and regulatory landscapes to maintain current knowledge Effectively managing timelines while working in a fast-paced and dynamic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and other aspects of drug development (eg, nonclinical , pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex clinical and clinical ... pharmacology documents (eg, pivotal Phase 3 CSRs, NDA/BLA/MAA submission documents, and briefing books) with minimal input from functional area experts; Ensure key messages are clear and consistent within and across documentsCritically review documents… more
- J&J Family of Companies (Spring House, PA)
- Johnson & Johnson is recruiting for Nonclinical Submissions Writer, Preclinical Sciences and Translational Safety to join our team located at our Spring House, PA ... reach their potential. At Johnson & Johnson, we all belong. The Nonclinical Submissions Writer will prepare and review regulatory submission documents that summarize… more
- AbbVie (North Chicago, IL)
- …The primary function of this role will be to serve as a nonclinical safety representative for assigned molecules across AbbVie's diverse portfolio. As a safety ... be responsible for the overall strategy and execution of the nonclinical toxicology program, collaborating cross-functionally with project leads, providing data… more
- UTMB Health (Galveston, TX)
- Regulatory Scientist I / II - Institutional Office of Regulated Nonclinical Studies (ORNcs) **Galveston, Texas, United States** Research Academic & Clinical UTMB ... conjunction with the Scientific Director for the Institutional Office of Regulated Nonclinical Studies (ORNcS), study sponsors and/or funding agencies to design and… more
- TD2 (Scottsdale, AZ)
- …goal? To help patients. Position Summary: The Program Administrator - Nonclinical Operations is a cross-functional position primarily providing support to TD2 ... IACUC and Nonclinical Operations management teams. The IACUC and Program Administrator acts as IACUC Secretary, aiding IACUC Chair in ensuring all studies conducted… more
- UWorld, LLC (Dallas, TX)
- …on a mutually agreed-upon schedule (typically ~25-40% clinical and ~60-75% nonclinical ). Requirements + ABIM(R)-certified or eligible MD + Exceptional communication ... skills, superior medical knowledge, and passion for training future physicians + High scores on ABIM(R) and USMLE(R) Step 1, 2, and 3 examinations + Prior experience in writing board-style questions, tutoring medical students, or working in an academic… more
- Lilly (Indianapolis, IN)
- …quality on-time submission documents. The SCR will perform a myriad of Nonclinical data quality review activities, Nonclinical submission coordination for ... new tools. Are you ready to play a critical role in shaping nonclinical submissions that drive regulatory success and advance groundbreaking therapies? Join the… more
- UTMB Health (Galveston, TX)
- …* Working knowledge of FDA 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies; * Working knowledge of FDA 21 CFR Part 11, Electronic ... whole or in part, the Institutional Office of Regulated Nonclinical Studies (ORNcS). **Job Duties:** Supervision + Schedule and...Food & Drug Administration (FDA) Good Laboratory Practice for Nonclinical laboratory Studies (21 CFR Part 58) and the… more
- Sumitomo Pharma (Columbus, OH)
- …relationship with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical , clinical and CMC documentation (eg nonclinical study reports, ... and general product development in the pharmaceutical industry + Experience reviewing nonclinical , clinical and CMC documentation (eg nonclinical study reports,… more
- J&J Family of Companies (San Diego County, CA)
- …independently as Target Clinical Pathologist on global PSTS teams, leads complex nonclinical safety biomarker strategies in support of drug development projects and ... Key Responsibilities: + Independently develops comprehensive fit-for-purpose and innovative nonclinical safety biomarker strategies for projects across modalities and… more
- Lilly (Indianapolis, IN)
- …location. The anticipated wage for this position is $63,000 - $162,800 The Nonclinical Study Management Team (NSMT) is a hardworking and diverse team looking for ... an experienced Toxicology study monitor with expertise in management of nonclinical safety assessment study conduct, including the fundamentals of Good Laboratory… more
- AbbVie (North Chicago, IL)
- …is responsible for providing statistical support across a broad range in nonclinical areas with a focus on Chemistry, Manufacture and Control (CMC), expanding ... CMC studies and regulatory submissions. Participate in establishing departmental and nonclinical SOPs and guidelines. Develop statistical tools to streamline process… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …an effective Quality & Compliance Governance framework across nonclinical , clinical and pharmacovigilance functions that empowers decision-making through ... effective Q uality and C ompliance G over n ance framework across nonclinical , clinical and pharmacovigilance in partnership with RDQ Leadership Team, Global Quality… more
- AbbVie (North Chicago, IL)
- …amendments, and report components + Assist in the technical conduct of nonclinical studies including protocol set-up in electronic data capture system and scheduling ... for key tasks in the set-up and conduct of nonclinical studies + Support the Study Director, acting as...+ Previous experience in the conduct and/or reporting of nonclinical studies Position will be filled at level commensurate… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience in managing pathology labs and teams in a discovery and nonclinical setting. + Oversee and drive the development of investigative pathology capabilities ... Safety Therapeutic Area Leaders in the development and execution of nonclinical safety and investigative strategies for discovery and development stage programs.… more
- AbbVie (Irvine, CA)
- …for data collection and analyses, interpretation, and reporting of results of nonclinical in vivo pharmacology studies. This individual is expected to advise and ... to help set strategy. S/he may serve as a pharmacology representative on nonclinical and translational sub-teams and assignments and will act as a subject matter… more
- AbbVie (North Chicago, IL)
- …manage the report coordination of Toxicology and Pathology reports within Nonclinical . Working cross-functionally with Study Directors, Pathologists, QA, and Report ... knowledge to carry out job functions. Preferred: + Experience supporting nonclinical research and development in the pharmaceutical industry preferred. + Experience… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. The Nonclinical Safety Assessment group is seeking a Toxicology Project Leader to join our team. ... or training **Additional Skills/Preferences:** + Experience developing and coordinating nonclinical development strategies for various stages of pharmaceutical development… more
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