- Lilly (Indianapolis, IN)
- …analyze, and interpret toxicological data, ensuring accuracy and compliance with regulatory standards. + Prepare and present project findings, updates, and reports, ... + Proficiency in data analysis and interpretation. + Experience in the drug discovery and development process. + Strong problem-solving skills. + Experience with… more
- Taiho Oncology (Princeton, NJ)
- …the global development program(s) + Answer medical questions raised by Regulatory Agencies (RA) and Institutional Review Boards/ Ethics Committees (IRBs/ECs) ... and Abilities: + Strong working knowledge of the US/EU drug development process required. + ≥ 8 years of...IB, ICF, CRF, CSR, DSUR, PBRER, and documents for regulatory interactions). + Ability to learn, integrate complex information,… more
- Bristol Myers Squibb (Princeton, NJ)
- …a department within the Research organization that facilitates the transition of drug candidates from early to late-stage clinical development, their approval and ... dose-schedule and responsive patient populations, based on deep understanding of drug mechanism of action and disease segments. Late-stage translational development… more
- Lilly (San Diego, CA)
- …mechanism-relevant biomarkers for assets in Lilly's immunology pipeline and develop drug tailoring hypotheses in various autoimmune diseases that can be implemented ... findings for disclosure at conferences and in journals. + Protocol and regulatory support for the biomarker portion of Immunology clinical programs. + Identify… more
- Teledyne (Torrance, CA)
- …PowerPoint and Outlook. In our efforts to maintain a safe and drug -free workplace, Teledyne Reynolds requires that candidates complete a satisfactory background ... check and pass a drug screen prior to employment. Due to the type...to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high… more
- Genentech (South San Francisco, CA)
- …and immunology required + In-depth understanding and recognized scientific leader in drug and biomarker development processes and regulatory requirements from ... and strategies to support clinical trials, and derive new research directions and drug discovery insights from patient samples and data. This role requires an… more
- IQVIA (Durham, NC)
- …global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle and operational clinical trial delivery + Robust and ... current knowledge of scientific, clinical, regulatory , commercial and competitive landscape in applicable therapeutic area + Strong leadership skills, ability to… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …role, you will have opportunities to inform multiple aspects of the drug development process including optimizing drug candidates through mechanistic simulation, ... + Provide expert guidance across teams as needed + Contribute to regulatory documents using the appropriate level of documentation and reproducibility + Maintain… more
- Reyes Holdings (Rosemont, IL)
- …the global cybersecurity strategy in alignment with business objectives and regulatory requirements + Oversee the planning, implementation, and operation of cyber ... in the Talent Acquisition or Human Resources departments. Background Check and Drug Screening Offers of employment are contingent upon successful completion of a… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …etc.) to ensure that materials and strategies are compliant with legal and regulatory requirements as well as with internal company policies. + Negotiate, draft, ... FDA regulations, OIG guidance, PhRMA Code, Federal healthcare programs, state drug transparency laws, HIPAA/privacy, etc.). + Negotiate, draft, and review market… more