- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. + Provide expert technical oversight of upstream ... and improvements post-approval. + Author and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with Company policy and strategy and gain a consensus of risk mitigation approaches. **Key Responsibilities:** + **Inspection Readiness:** Ensure continuous ... and develops systems for Clinical vendor management and vendor oversight . + **Management Review:** Establish and maintain a system...our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of… more