Associate Director - PV Project Management (PV PM) Global Patient Safety
Eli Lilly and Company
12 hours ago
Remote friendly (Indianapolis, IN)
United States
Operations
Purpose
- The Associate Director, PV Project Management (PV PM) is a key leader within the GPS Capabilities Portfolio Management Office (PMO), guiding the strategic execution of GPS initiatives across cross-functional teams. Ensures alignment with organizational goals, regulatory expectations, and operational excellence through strong project/program management.
Responsibilities / Primary Responsibilities
- Lead and coordinate team members and external partners to deliver projects; develop and implement organizational change strategies.
- Develop and execute a team communication plan aligned with overall strategy.
- Use project management skills/tools/processes to support decision-making and lead cross-functional teams delivering safety-related projects/results.
- Adapt to different document types, therapeutic areas, and product teams across development and post-marketing.
- Identify and communicate critical paths, progress indicators, and major achievements across multiple products.
- Coordinate kickoff, strategy, safety team meetings, and comment-resolution discussions; prepare and share meeting materials (agendas, pre-reads, data summaries, minutes).
- Build cross-functional partnerships to ensure timely deliverables; support organizational/cross-functional projects.
- Manage PV/safety timelines, key milestones (aligned with quality standards), integrated project budgets, and vendor selection processes (as assigned).
- Manage information/access; maintain high-quality content and ensure appropriate access to key information.
- Identify/prioritize risks, communicate to leadership, develop risk-reduction plans; track metrics, ensure compliance with standards, and use data to improve outcomes.
- Model Team Lilly behaviors (Include, Innovate, Accelerate, Deliver); provide coaching and feedback.
- Participate in shared learning: capture teachings across functions, conduct after-action reviews, recommend improvements to processes/tools/training/guidance.
- Follow relevant quality system requirements, laws/regulations; maintain compliance with training and standard operating procedures; support preparation for regulatory inspections and internal audits.
- Support the EU Qualified Person for Pharmacovigilance (QPPV) responsibilities to meet legal obligations.
- Ensure project landmarks are delivered on time, within scope, and with high quality; document and analyze performance data; hold teams accountable; demonstrate independent problem-solving.
- Coach/mentor PV PMO project managers and lead/coordinate work in a matrixed environment.
Basic Requirements
- Bachelor’s degree in life sciences, business, or related field; advanced degree preferred.
- 6+ years of project management experience in pharmaceutical/biotech/healthcare.
- Experience leading in cross-functional and matrixed environments.
- Experience with project management tools (e.g., MS Project, Smartsheet).
- Experience with PMI principles.
Additional Preferences (Desired)
- MS/MBA/Master’s in project management or PMP; PMP certification preferred.
- Knowledge/experience of drug development processes in therapeutic areas.
- Excellent verbal and written communication; strong problem-solving and root-cause/corrective action skills.
- Strong self-management/organizational skills; emotional intelligence and teambuilding.
- Flexibility with frequent changes/altered priorities.
- Applied knowledge of project management processes (integration, scope, time, cost, quality, HR, communications, risk, procurement, partners).
Benefits (if explicitly included)
- Eligibility for a company bonus (based on company and individual performance).
- Comprehensive benefits: 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits (e.g., healthcare and dependent day care FSAs); life insurance/death benefits; time off/leave of absence; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Compensation (as stated)
- Anticipated wage: $115,500 - $169,400.
Application Instructions (as stated)
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- The Associate Director, PV Project Management (PV PM) is a key leader within the GPS Capabilities Portfolio Management Office (PMO), guiding the strategic execution of GPS initiatives across cross-functional teams. Ensures alignment with organizational goals, regulatory expectations, and operational excellence through strong project/program management.
Responsibilities / Primary Responsibilities
- Lead and coordinate team members and external partners to deliver projects; develop and implement organizational change strategies.
- Develop and execute a team communication plan aligned with overall strategy.
- Use project management skills/tools/processes to support decision-making and lead cross-functional teams delivering safety-related projects/results.
- Adapt to different document types, therapeutic areas, and product teams across development and post-marketing.
- Identify and communicate critical paths, progress indicators, and major achievements across multiple products.
- Coordinate kickoff, strategy, safety team meetings, and comment-resolution discussions; prepare and share meeting materials (agendas, pre-reads, data summaries, minutes).
- Build cross-functional partnerships to ensure timely deliverables; support organizational/cross-functional projects.
- Manage PV/safety timelines, key milestones (aligned with quality standards), integrated project budgets, and vendor selection processes (as assigned).
- Manage information/access; maintain high-quality content and ensure appropriate access to key information.
- Identify/prioritize risks, communicate to leadership, develop risk-reduction plans; track metrics, ensure compliance with standards, and use data to improve outcomes.
- Model Team Lilly behaviors (Include, Innovate, Accelerate, Deliver); provide coaching and feedback.
- Participate in shared learning: capture teachings across functions, conduct after-action reviews, recommend improvements to processes/tools/training/guidance.
- Follow relevant quality system requirements, laws/regulations; maintain compliance with training and standard operating procedures; support preparation for regulatory inspections and internal audits.
- Support the EU Qualified Person for Pharmacovigilance (QPPV) responsibilities to meet legal obligations.
- Ensure project landmarks are delivered on time, within scope, and with high quality; document and analyze performance data; hold teams accountable; demonstrate independent problem-solving.
- Coach/mentor PV PMO project managers and lead/coordinate work in a matrixed environment.
Basic Requirements
- Bachelor’s degree in life sciences, business, or related field; advanced degree preferred.
- 6+ years of project management experience in pharmaceutical/biotech/healthcare.
- Experience leading in cross-functional and matrixed environments.
- Experience with project management tools (e.g., MS Project, Smartsheet).
- Experience with PMI principles.
Additional Preferences (Desired)
- MS/MBA/Master’s in project management or PMP; PMP certification preferred.
- Knowledge/experience of drug development processes in therapeutic areas.
- Excellent verbal and written communication; strong problem-solving and root-cause/corrective action skills.
- Strong self-management/organizational skills; emotional intelligence and teambuilding.
- Flexibility with frequent changes/altered priorities.
- Applied knowledge of project management processes (integration, scope, time, cost, quality, HR, communications, risk, procurement, partners).
Benefits (if explicitly included)
- Eligibility for a company bonus (based on company and individual performance).
- Comprehensive benefits: 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits (e.g., healthcare and dependent day care FSAs); life insurance/death benefits; time off/leave of absence; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Compensation (as stated)
- Anticipated wage: $115,500 - $169,400.
Application Instructions (as stated)
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation