- Bristol Myers Squibb (Devens, MA)
- …Read more: careers.bms.com/working-with-us . **Position Summary** Reporting to the Director , Inspection Readiness , the Associate Director will help ... Associate Director will support BMS' GMP/GDP Inspection Readiness strategy by supporting on-site and...should be directed to Chat with Ripley. R1594771 : Associate Director , Inspection Readiness… more
- Sumitomo Pharma (Boston, MA)
- …compliance with regulatory expectations for BC/DR in pharmaceutical environments. + **Audit & Inspection Readiness ** + Serve as the primary IT contact for ... internal audits, regulatory inspections, and third-party assessments. + Ensure timely resolution of audit findings and continuous improvement of compliance posture. + **Policy & Standards Development** + Establish IT policies and standards for data integrity,… more
- Takeda Pharmaceuticals (Boston, MA)
- …for key regulatory meetings as appropriate. + Leads Clinical Operations aspects of inspection readiness activities and acts as subject matter expert during ... regulatory inspections. + Lead or participate in cross-functional strategic initiatives and process improvement. + Actively seek new ways of working more efficiently to meet the needs of clinical development. + Demonstrate advanced Takeda Leadership Behaviors… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of various periodic reports (ie, Annual Report, PSUR, PADER, etc.). + Support inspection readiness activities related to all global labeling components. + ... Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed. + Develop clear communications for senior management and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** Under the direction of the Director / Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the ... forecast. * Provide timely communication of any variances in budget forecast to the Director / Associate Director . * Establish communication flow with CRO and… more