Associate - PV Project Management (PV PM)

Eli Lilly and Company • Indianapolis, IN

23h • $65,250 - $165,000

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: PV Project Management is a diverse and engaged group of drug development experts purposefully leading and running projects and the portfolio to deliver needed medicines for patients. The Associate, Sr. Associate, & Manager (P1-3) PV Project Management (PV PM) provides strategic and operational drug development leadership in Global Patient Safety across the Research and Development portfolio, integrating drug development across all functions and translating strategy into execution to deliver medicines to patients. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Collaborate with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Facilitate and Support Global Patient Safety through Project Management Tools and Processes Use project management skills, processes, and tools to enable effective decision making and lead cross-functional teams to implement safety results and projects. Exhibit flexibility in moving across document types, therapeutic areas, and asset/product teams, depending on project assignment from development through post marketing activities. Identify and communicate the critical path and leading indicators of team progress and major landmarks across multiple products. Responsible for coordinating and managing kick off, strategy, safety team, and comment resolution meetings. Provide suitable timelines for documentation as applicable (e.g. agendas, pre-reads, relevant data outputs, and minutes for meetings) Partner and communicate with cross-functional team members on an ongoing basis to ensure results are completed to established timelines. Support projects as needed including those which are organizational and cross-functional in nature Timeline Management: Facilitate the creation and execution of PV and Safety related project plans and delivery of project achievements. Hold functions accountable for achievement of key project deliverables in alignment with safety related project plans and in compliance with corporate quality standards. Cost Management: Drive development and optimization of a global integrated project budget while maintaining alignment with functional representatives and leadership. Communication Management: Develop and implement a team communication plan driving accurate and timely communication of key project changes to the appropriate stakeholders both internal and external. Information and Access Management: Provide quality and timely content leveraging project management tools and ensure team members have appropriate access to information. Project risk management: Monitor and prioritize project risk with the team and communicate status of potential risks to leadership as appropriate; propose strategies to minimize risks and implement contingency plans when vital. Metrics and Monitoring Monitor and analyze project performance metrics, ensuring compliance with industry standards. Use data-driven approaches to enhance project outcomes and organizational performance. Leadership: Demonstrate the Team Lilly behaviors of Include, Innovate, Accelerate, and Deliver to influence without authority and enable team efficiency using judgement-based decision making. Contribute to the development of others by being an active source of coaching and feedback. Application/Improvement of Processes (Shared Learning) Identify and leverage opportunities to capture and share insights across different functions. Engage in retrospective project and process review meetings (i.e., after-action reviews) to identify issues and strengths and facilitate knowledge retention. Highlight and propose areas for ongoing process improvement to the team and function. Identify, share, and incorporate procedures into future iterations of processes, tools, training, or guidance. Adhere to requirements in quality system documents and process improvement initiatives to ensure compliance with local laws and regulations Maintain compliance with all required training and standard operating procedures Provide support and prepare for regulatory inspection and internal audits Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (QPPV) and ensure support is provided to fulfill the QPPV legal responsibilities.

Requirements

• Four-year degree, preferably in a health-related, scientific, or engineering field with a minimum of 3 years of work experience in the pharmaceutical industry, drug development, or project management.
• Experience leading in a cross functional environment.

Nice To Haves

• Higher degrees or certifications (e.g. MS., MBA, Masters in Project Management or PMP).
• Previous experience with or knowledge of drug development processes.
• Excellent verbal and written communication skills.
• PMP Certification Preferred

Responsibilities

• Facilitate and Support Global Patient Safety through Project Management Tools and Processes
• Use project management skills, processes, and tools to enable effective decision making and lead cross-functional teams to implement safety results and projects.
• Exhibit flexibility in moving across document types, therapeutic areas, and asset/product teams, depending on project assignment from development through post marketing activities.
• Identify and communicate the critical path and leading indicators of team progress and major landmarks across multiple products.
• Responsible for coordinating and managing kick off, strategy, safety team, and comment resolution meetings.
• Provide suitable timelines for documentation as applicable (e.g. agendas, pre-reads, relevant data outputs, and minutes for meetings)
• Partner and communicate with cross-functional team members on an ongoing basis to ensure results are completed to established timelines.
• Support projects as needed including those which are organizational and cross-functional in nature
• Facilitate the creation and execution of PV and Safety related project plans and delivery of project achievements.
• Hold functions accountable for achievement of key project deliverables in alignment with safety related project plans and in compliance with corporate quality standards.
• Drive development and optimization of a global integrated project budget while maintaining alignment with functional representatives and leadership.
• Develop and implement a team communication plan driving accurate and timely communication of key project changes to the appropriate stakeholders both internal and external.
• Provide quality and timely content leveraging project management tools and ensure team members have appropriate access to information.
• Monitor and prioritize project risk with the team and communicate status of potential risks to leadership as appropriate; propose strategies to minimize risks and implement contingency plans when vital.
• Monitor and analyze project performance metrics, ensuring compliance with industry standards.
• Use data-driven approaches to enhance project outcomes and organizational performance.
• Demonstrate the Team Lilly behaviors of Include, Innovate, Accelerate, and Deliver to influence without authority and enable team efficiency using judgement-based decision making.
• Contribute to the development of others by being an active source of coaching and feedback.
• Identify and leverage opportunities to capture and share insights across different functions.
• Engage in retrospective project and process review meetings (i.e., after-action reviews) to identify issues and strengths and facilitate knowledge retention.
• Highlight and propose areas for ongoing process improvement to the team and function.
• Identify, share, and incorporate procedures into future iterations of processes, tools, training, or guidance.
• Adhere to requirements in quality system documents and process improvement initiatives to ensure compliance with local laws and regulations
• Maintain compliance with all required training and standard operating procedures
• Provide support and prepare for regulatory inspection and internal audits
• Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (QPPV) and ensure support is provided to fulfill the QPPV legal responsibilities.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level