CMC Project Planner, Drug Development

Job description

Ref: MEC 231C

 

Principal accountabilities

Developing, maintain and report on CMC development plans for one or more drug development program/projects

- Ensure information collection from function experts to keep CMC project plans  up-to-date  (reflect all scope elements and update timelines OOP estimates for identified scope elements)

- Liaise with functional line managers to ensure resource estimates get reflected in the CMC project plans

- Liaise with development operations team to align on the transactional processes inherent to the outsourcing model for development activities

Collaborate with the development project manager to ensure alignment between the Integrated Development Plan and the CMC Development Plans

- Assess impact of CMC project plan changes on the Integrated Development Plan, and its critical path

- Liaise with the development project manager and function experts to resolve planning conflicts by evaluating  alternative scenario’s

- Run the necessary project plan reports and ensure distribution thereof to the stakeholder pool

Collaborate with the development project manager, function experts and function department heads to execute budget and forecast processes

Requirements

Education

-Minimal a Bachelor degree in biosciences, management or related

Experience

-3+ years  Pharma R&D experience with exposure to drug development
-Experience with project planning and EPPM tools
-Experience with budget management and financial reporting requirements

General skills

-Strong team player with good interpersonal skills

-Ability to work accurately and deliver against strict timelines 

Communication skills

-Ability to adapt to the audience
-Fluent in English
-Knowledge of Dutch and French is a plus