- An accomplished, self - motivated, results-oriented Project Manager consultant, with a track record of excelling in fast-paced environments with the ability to work independently as well as lead project teams in global environments, on both long and short-term projects.
- Experienced in serving as a primary point of contact and liaison between management, project teams (both IT and business), and internal and external clients.
- A dedicated leader, with a collaborative approach and a results-driven focus on resolving operational challenges with innovative solutions, systems and process improvements.
AREAS OF EXPERTISE
- Stakeholder Management
- Global Program and Project Planning
- Project Tracking Tools and Systems
- Record Management
- KOL Engagement and Management
- Global and Local Compliance
- Business process improvement
- Budget Reporting and Management
- Executive presentation development
- Oversight of Phase I, 2 & 3 of major Global Pharmacovigilance Signal Tracking System upgrade
- Manage Schedule, Budget, and Risk to ensure that project is completed on time (end of September).
- Plan future Commitment Tracking System Upgrade
- Oversight of the compliance and regulatory process for releasing assigned scientific publications.
- Independent review, troubleshooting, and resolution of issues with publication documentation.
- Designed/developed and standardized department progress reports, requirements documentation, meeting presentations and other PM tools. Recommended process for monitoring project timelines and milestones using Anaplan software.
- Build, roll-out and management of the Corporate Compliance Auditing SharePoint site. Trained global users and created training documentation. Maintained Quality Management Review monthly metrics reporting for planned & completed audits.
- Updated and maintained SharePoint site to reflect current and updated audit related documentation and information; archived applicable records.
- Managed end to end compliance of KOL contracting and budgeting process related to applicable regulatory requirements.
- Coordinated weekly meeting with Regulatory to identify and establish support needs to meet timeline.
- Managed logistical details for mock meetings, including preparation and distribution of agendas in advance of the meetings.
- Established relationships with KOLS and maintained ongoing communications and information exchange throughout entire project.
- Managed vendors, including budget and contract/proposal negotiations; direct communication with vendor regarding KOL section process.
- Worked with legal to resolve any contract language issue resolution.
- Created process improvement documents for FMV process.
- Monitored /controlled assigned work streams on Windows 7 migration.
- Managed validation work streams (21 CFR Part 11) of applicable software.
- Communicated with cross-functional Global teams of project priorities, deadlines and deliverables.
- Regular attendee of weekly Executive Committee Meetings.
- Prepared timelines, monitored, tracked assigned projects, with focus on critical path issues.
- Assisted Global Program Lead with the identification of solutions optimizing critical work paths.
- Worked with outsourcing for SOW finalization for vendor.
- Monitored vendor performance; approved PO payments for work milestones.
- Created and maintained project plans for operations activities using MS Project.
- Data Migration during company separation.
- Risk Management Business Manager back-up for Global Affiliate activities.
- Assisted with record management for EMA Inspection.
- Administrator for SPORT and Affiliate Risk Management System (AFFIRMS) global proprietary SharePoint systems.
- Presented training sessions and developed materials.
- Authored work instructions and training guidelines for department process improvements.
- Reviewed and confirmed applicable department SOPs.