CMC Project Manager

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a CMC Project Manager, you will lead and manage regulatory affairs CMC projects, ensuring successful execution and delivery of project objectives.

Responsibilities:

• Responsible for achieving project goals, including timelines, budget, and scope
• Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between deliverables and define budget needs
• Track, monitor and report key milestones and decision points to drive delivery of projects in accordance with corporate objectives., balancing scope, cost, timelines and risk
• Build strong working relationships with internal and external key stakeholders to ensure timely completion of CMC activities by continuously monitoring progress
• Perform critical path analysis and risks, taking into account cross-functional interdependencies in the overall development project plan
• Coordinate on the delivery of those critical path items through prioritization setting where required and mitigate or escalate the risk together with the project team
• Perform scenario simulations and advise on optimum development planning
• Prepare and lead project team meetings including issuance of agenda, actions and meeting minutes to be documented, communicated and committed
• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team

Requirements:

• Life Sciences degree
• strong CMC project experience
• Experience in working with biologics
• Excellent planning and organizational skills, able to multi-task in a multicultural environment and prioritize
• Strong analytical, problem solving and critical thinking skills with action-oriented follow through
• MS Project, Power BI, or Planisware experience
• Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred and capable of building effective relationships