Regulatory Cmc Operations Group Team Leader
Groton, Ct
Directed the Pharm Sci regional support team for the successful completion and submission of the Chemistry, Manufacturing, and Controls (CMC) section of Pfizer’s regulatory dossiers.• Assessed the document management and system support needs of product development teams; assigned Operations Group personnel to support projects. Achieved consistent completion of submissions by corporate assigned due date.• Provided business analysis and system requirements for PS GDMS. Contributed to the successful design, release, deployment, and user acceptance of the new system.• Co-authored and approved all training materials, and conducted user training. Succeeded in promoting user adoption of system as measured by account creations.• Represented Pharm Sci as Business Lead on cross-divisional team for Worldwide Development’s Document Management and Publishing System support team. Defined user and system requirements, approved on-line training modules, and ensured compliant use of the system in support of submissions.