Role and main tasks:
- Individually or as part of a project team responsible for implementation and maintenance of document processes and systems by ensuring the development, review, approval, distribution and withdrawal of process documents (PDs), including policies (POLs), Standard Operating Procedures (SOPs) and guidance documents (GUIs).
- Responsible for optimization of relevant processes by organizing, planning and prioritizing the document management in line with company policies and in cooperation with the Operational Excellence department, as appropriate.
- Optimize and prioritize quality and productivity through implementation of process documents management systems and by effectively managing relationships with service providers in solving issues around document storing, archiving and provisioning.
- Coordinate document management system upgrades and periodical maintenance (repository, training profiles, planning, obsolete PD review, etc...).
- Provide advice on document practices to users and support requests related to:
- Evaluation of need for PDs to determine the appropriate PD type
- Development, review or update of PDs in collaboration with the process owner to ensure compliance and integrity of references
- Review of drafts to ensure readability and consistency with template
- Provision of PDs to auditors
- Ensure communication to and liaise with business to ensure alignment on global strategy, provide training on process updates and ensure stakeholder review.
- Bachelor’s degree in computer science or business management
- Former experience as a document manager is an excellent plus
- Ability to lead cross-departmental and multidisciplinary teams
- Perform his/her work in a cGMP consistent manner
- Experience in the Pharmaceutical industry is ideal but not mandatory
- Demonstrated analytical, planning and organizational skills
- MS Office
- French: Fluent
- English: Business
- Ideally other languages would be a great advantage, such as Dutch and German, even at basic beginner level
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.