Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a Project Coordinator with experience in Regulatory Affairs to manage delivery, quality, timeline and budget of a cross-functionalproject
Start: ASAP
Length: 6 months
Location: South of Brussels
Function Description:
The Project Coordinator/Manager will primarily be focused upon supporting a cross-functional project.
The Project Coordinator/Manager will support the Regulatory,Quality/Manufacturing and Supply organisations to manage delivery,quality, timeline and budget of Project EDGE.
Key Responsibilities:
- Develop, update and communicate robust and predictable project plans utilising project management
best practice;
- Develop and update required resources for execution of project inline with risk mitigation strategy -
ensure resource planning across all departments to deliver project plan;
- Drive execution, coordinate and track progress of project schedule;
- Interface with appropriate functional groups to source required documents;
- Coordinate Project EDGE steering meetings (eg, meeting invites,agenda, preparation and distribution
of meeting minutes)
- Provide input into the project based upon their knowledge and experience of the pharmaceutical
industry;
- May represent Regulatory Affairs in project teams under supervisordirections
- May be required to write documents, including for example, SOPs, Guidance documents etc.
Competences:
- A knowledge of the pharmaceutical industry (the ideal candidate wouldhave a broad overview of Manufacturing, Quality, Supply and Regulatory);
- A more detailed knowledge of RA aspects in general would be helpful;
- An understanding of the principles of GCP, GMP, and ICH guidelines;
- Good communication skills;
- Knowledge in the use of document management tools and techniques;
- Attention to detail, ability to product documents of high standard. Must demonstrate integrity
and consistent work approach;
- Strong organizational and interpersonal skills;
- Ability to work in a team environment with shifting priorities andrequirements;
- Excellent English skills - both written and verbal (the candidate will also need to work closely with UK based personnel).
Required level of education and required work experience in this role:
- A university level degree in a scientific discipline with appropriate Project Management methodology qualification &/or good Project Management experience
Tags: GMP, Regulatory, Réglementaire, Project, Projet