Insourced Project Planner

Planning/Controlling (Scheduling and Resource Management)

• Responsible for coordinating, monitoring and reporting project schedule and resource management information to enable alignment of PRD and partner line schedules and FTE/dollar resources. These schedules include:
• Clinical study plans (Protocol Development to Final Clinical Study Report) and Clinical Operation Submission activities to support Module 1 and 5 of the submission plan.
• Identifies and raises schedule conflicts, risks, and resource peaks/troughs appropriately for resolution.
• Directly participates in and contributes to cross-functional and functional teams to discuss, review, and optimize protocol/project/program schedules and study cost estimates.
• Monitors progress of project activities towards next project milestone, anticipates and highlights potential variances, supports line/team in critical path analyses and understanding the impact.
• Performs scenario planning of project timelines within and across protocols and across disease area/portfolio to enable optimum use of local, global, and outsourced resources to ensure efficient delivery of project milestones.
• Project Execution and Delivery
• Partners with key team members (e.g., PM, Medicinal Sciences, CS&O, DSRD, Commercial) to manage the project and achieve key milestones according to the endorsed timeline, cost, and quality parameters.
• Contributes to risk management through the identification of operational and project/program risks for discussion with appropriate team leadership. Participates in team discussions to de-risk projects and develop new options to resolve moderately complex issues.
• Provides the Portfolio Management group with project schedule information to enable effective portfolio management activities. Analysis and Reporting
• Produces what-if scenario analyses (base, optimistic and pessimistic development) based on context obtained from project team members (e.g. PM, Medicinal Sciences, CS&O, DSRD, Commercial). Decisions taken by the team based on these analyses may impact project delivery, costs, and resource requirements.
• Reviews own work regarding quality of schedule and resource metadata through utilization of quality reports and monitoring/management of such data with the team/line members.
• Provides timely reporting to the PM, Portfolio Management, and project teams, alerting them to the possibility of endangered/missed or conflicting milestones and critical path activities.
• Ensures regular information updates and analysis and interpretation of planning and forecasting data to project teams, Portfolio Management, platform lines, and management teams.
• Utilizes available reporting and visualization tools to support governance and team reporting needs (e.g. OnePager, Business Objects, Spotfire).
• Provides context to local customers of reports generated globally and consolidates customer feedback to enable improvement of existing reports and generation of new reports. Process
• Partners with project team members (e.g. PM, Medicinal Sciences, CS&O, DSRD, Commercial) to identify opportunities and potential solutions to realize efficiency in the development process.
• Contributes to continuous improvement of project plans, plan generation, plan utilization, and/or report creation/development processes. Qualification: Education
• Bachelors level degree.
• B.S. with 2+ years' experience or M.S. with 1-2 years' experience. Experience
• At least 1 year experience in project planning and project management.
• At least 2 years’ experience in pharmaceutical industry or related/similar industry.
• Beneficial Relevant Capabilities
• Project Management Professional (PMP) certification preferred but not required.
• Experienced in end-game/regulatory submission planning and/or product launch planning.
• Experienced with planning and resource forecasting tools (e.g., MS Project, Planisware, OnePager).
• Experienced user of reporting and office software (e.g., MS Office, Business Objects, Spotfire).
• Trained/experienced in negotiation, facilitation and managing cross-functional team dynamics. Key Skills: Portfolio Management; Pharma R&D; Drug Development; Project Management Professional (PMP) ; ‌PCC(Preclinical Candidate Compound); ‌IND (Investigational New Drug) ;‌NDA‌（New Drug Application）