- Sumitomo Pharma (Pierre, SD)
- …literature evaluation, investigator site training, continuing education for internal staff, inspection / audit readiness , audits, and inspections. + Prepares ... + Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …assessment activities, in partnership with risk program and SMEs. + Support the overall inspection readiness of the GCP Audit program, including preparation ... life-saving therapies to patients around the world? **KEY RESPONSIBILITIES:** _GCP Audit Program Leadership_ + Accountable for the successful oversight and… more
- J&J Family of Companies (Spring House, PA)
- …requirements and internal procedures, and to maintain a continued state of inspection readiness . **Key Responsibilities** : With supervision from the Director, ... Quality Stage Gate Review (SGR) + Supports SGR content development & follow-up activities Inspection Readiness and Support + Supports ongoing inspection … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- … readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations. + ** Audit Management:** Oversee the planning, execution, ... policy and strategy and gain a consensus of risk mitigation approaches. **Key Responsibilities:** + ** Inspection Readiness :** Ensure continuous inspection… more
- Pfizer (New York, NY)
- …disease areas, including engagement in continuous improvement initiatives + Provides active inspection readiness support, including provision of data for metrics ... Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit , etc) to enable one medical voice + Articulating clear and… more