- Sanofi Group (Cambridge, MA)
- …(eg clinical operations, project management, Patient Safety and Pharmacovigilance , regulatory, Finance, Scientific External Engagement, Procurement etc ), ... responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures… more
- Takeda Pharmaceuticals (Boston, MA)
- …Quantitative Sciences, Programming, Global Evidence Outcomes, Patient Safety & Pharmacovigilance , and Strategic Operations The department integrates data science, ... analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate… more
- Astellas Pharma (Northbrook, IL)
- …+ Collaborate with key stakeholders (eg Regulatory Affairs, Labelling, Pharmacovigilance , Commercial) to create competitive and optimized product labels aligned ... with regulatory requirements and market needs **Stakeholder Engagement:** + Build and maintain strong relationships with external stakeholders, including diagnostic partners, testing labs, key external experts, advocacy groups, medical organizations and… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …Commercial, Medical Affairs, Nonclinical Toxicology, Clinical Pharmacology, CMC, and Global Pharmacovigilance . + Support and guide team through all Scientific Review ... Board and Endorsement Board interactions, as part of the EDO. **Cross-Functional and Governance Leadership** + Provide subject matter expertise and input to multidisciplinary teams across Discovery, Bioanalysis, Biomarkers, Toxicology, Clinical Operations,… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …at all levels of the organization + Demonstrates an awareness of pharmacovigilance regulations and methodology + Demonstrates a solid understanding of scientific ... methodology in the design, conduct, interpretation and reporting of clinical research projects with emphasis on safety monitoring + History of working seamlessly with Clinical Operations Physical Requirements: + Some limited travel required Approximately 15%.… more
- Sanofi Group (Morristown, NJ)
- …benefit-risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team + Implements strategies to identify, ... monitor and resolve clinical program/trial issues. + Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data. + Provide appropriate medical input & support for all activities related to clinical studies… more
- Takeda Pharmaceuticals (Boston, MA)
- …& Compliance provides strategic quality oversight to clinical, medical, and pharmacovigilance suppliers across Takeda's global network. You will lead the risk-based ... supplier audit program, drive compliance insights, and partner closely with stakeholders to ensure adherence to GCP, GCLP, and GVP standards. This role combines audit leadership, supplier oversight, and strategic risk management to enhance end-to-end clinical… more
- Sanofi Group (Morristown, NJ)
- …(eg clinical operations, project management, Patient Safety and Pharmacovigilance , regulatory, Finance, Scientific External Engagement, Procurement etc.), ... responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures… more
- Lilly (Durham, NC)
- …working in at least two of Clinical Operations / Development, Pharmacovigilance , Product Research & Development or Commercial Manufacturing preferred. **A** ... **dditional Information:** + Available to travel (domestic and international) when required. + Fluent in English, additional languages are also recommended. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce,… more
- Sanofi Group (Cambridge, MA)
- …and capabilities needed for current services. + Ensure compliance with pharmacovigilance monitoring and reporting requirements. Ensure compliance with Sanofi Genzyme ... policies. + Recommend capabilities to scale personalized services. Identify opportunities to streamline processes, leverage technology and champion continuous improvement. + Maintain knowledge management tools, SOPS, workflows. Ensure approved resources are… more