Project manager for new drug development programs responsible for planning and managing execution of the full development process for a product including CMC, clinical, and regulatory activities.
Work with R&D Project Management team lead to plan new programs and then implements the plans.
Generates the Project Plan document including definition of project goals and objectives, scope, actions, risk assessment, timelines, project budget, deliverables, milestones, defining roles and responsibilities, and assigning resources.
Manage execution of the plan, updating the plan as necessary through change management.
Control risks related to success of the project including risks to quality, budget, and timelines.
Plans, attends, and coordinates project team meetings
Facilitate decision making and resolve project plan and team issues
Manage the project budget including review and approval of invoices.
Works closely with management to ensure the timely delivery and completion of project associated activities.
In addition to development and managing execution of the Project Plan, the PM is also responsible for review of project documentation such as protocols and reports, generation of submission documentation, and coordinating activities at contractors.
Participate in and contribute to Product Launch team meetings.
Bachelor’s degree in a relevant scientific discipline required.
Requires 7+ years related experience in the pharmaceutical industry.
Requires 5+ years of project management experience managing drug development projects.
Knowledge and understanding of the drug development process.
Must be able to manage multiple tasks and have excellent organization skills.
Flexible and able to work independently to manage work priorities.
Proficient with Project Management best practices and tools, including knowledge of and experience in generating Project Plans, evaluating risk factors, and generating timelines using Microsoft Project.
Strong interpersonal and communication skills.
Ability to lead and drive for results in cross-functional teams.
Quick learner, goal oriented and results driven with excellent problem-solving skills and ability to escalate issues appropriately.