Senior Manager, PST Project Management
- Applies advanced project management (PM) skills to concurrent projects of varying scope and complexity encompassing safety deliverables and business initiatives.
- Leads impact assessment of new guidelines, regulations. Leads inspection readiness activities and serves as SME for audits and inspections.
- SME for aggregate safety process and addressing PV commitments. Provides training across functional and global boundaries, including affiliates.
- Supports alignment and synergy of resources for meeting business objectives.
- Independently prioritizes project issues, refocuses objectives and proposes resolutions to Product safety Team (PST) Lead and stakeholders.
- Provides direction and oversight of compliance and quality initiatives related to Regulatory document development.
- Drives consistency of quality reports through utilization of appropriate work instructions and templates.
- Develops concepts and drives implementation plans for process improvement.
- Drives consensus and creates synergy of ideas through formal and informal dialogue and discussion.
- Oversees the capturing and reporting of defined metrics through use of industry standards and models. Directs cross functional team in production of aggregate safety reports. Interacts frequently across functions and with mid-level and senior-level management.
- BA/BS (prefer nursing or pharmacy, or healthcare professional), with 6+ years clinical or pharmaceutical experience.
- Education in biological/medical science or healthcare professional MA/B/MS (advanced degree preferred).
- Pharmaceutical Industry work experience (7 years).
- Ability to work independently, influence stakeholders, and present sound business strategies.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled