Expert Specialist

1 month ago


Petaling Jaya, Malaysia Lilly Full time

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**:
The demand for high quality real-world evidence (RWE) to support drug development, health technology assessment/access decisions, product differentiation, and clinical decision making continues to increase within the North Asia Pacific (NAPAC) region. The purpose of the NAPAC RWE team is to accelerate equitable patient access and transform healthcare delivery through the execution and communication of bold, high impact science. We are looking for a talented, energetic, independent, and organized project manager to join the team to aid in project management, metric tracking and administration.

The purpose of the RWE Project Manager (PM) role is to work with Medical Affairs and Market Access teams to facilitate and support RWE standard project management processes and tools for efficient and impactful execution of RWE studies and Quality Improvement initiatives (QI). The PM provides technical and project administrative support to the NAPAC hub (medical affairs, corporate affairs) to help enable strong study planning, on-time and on-budget delivery of key tasks during RWE project execution and performance tracking. The PM plays a key role as a resource to the business with regard to shared learning, process improvement, and identification of special needs. They will also manage RWE vendors and provide publication planning support.

**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. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
- Technical and project administrative support to NAPAC RWE team (50%)_
- Facilitates delivery of project milestones with quality on time, on budget, and within scope.
- Ensures good documentation practices in PANGAEA project management system. Uploads study protocols, reports and other study documents in the appropriate system for review, approval and storage. Conduct quality checks to ensure the accuracy and completeness of the information contained in our data sources
- Runs regular Pangaea reports to provide updates to internal stakeholders on key metrics such as volume of RWE activity, type and cost of projects and how the RWE deliverables are used both internally and externally.
- Creates dashboards in Pangaea for the NAPAC RWE team and Medical Lead Team
- Works with local and international functions to align resources based upon team prioritization decisions (e.g., quality, statistics, global scientific communications, VEO, GPS, PGV).
- Vendor Management (20%)_
- Initiates and processes qualification of new vendors with IBU and local Quality team
- Onboards new vendors to the region and ensures all Lilly requirements are met and trainings are complete
- Facilitates Vendor Requests for new project Proposals (RFPs)
- Contracts the RWE projects
- Liases with local legal, procurement and pharmacovigilance on contracting requirements
- Manages input into contracting and vendor systems (C3, TPET, WWTP, PANGAEA)
- Completes PO set-up, invoice processing, and record management in Pangaea.
- Completes internal documentation and archiving, Risk, Privacy and Quality assessments for each vendor
- Participates in MQO and PGV review of vendors and reporting of deviations and quality issues
- Publication planning and management (15%)
- Co-ordinates and tracks progress of all medical affairs and corporate affairs publications (RWE, consensus statements, literature reviews etc..)
- Works with IBU GSC (Global Scientific Communications) to ensure NAPAC SDs are in IBU or global SD plans and studies are approved by PSC (Publication Steering Committee)
- Work with project teams to ensure relevant documentation related to the publications is recorded in repositories and documented to DMT (documentation management team)
- Aids in the development and execution of communication plans for RWE studies to ensure internal and external impact.

F_acilitates and supports RWE Strategy in NAPAC (15%)_
- Helps to co-ordinate annual business planning cycle with cross-functional teams
- Develops tools, dashboards and trackers to facilitate efficient business planning and execution of RWE
- Drives local RWE meetings to agreed on ke


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