Role DescriptionWe are looking for a Regulatory Affairs Data Verification Specialist to coordinate and support data verification in the Marketing-Authorisation (MA) data tracking system in InSight.
This role is critical to ensure the accuracy of EMEA data in the MA data tracking system. The right candidate should be able to effectively drive decisions and enforce actions in a process which is still developing, to take appropriate EMEA decisions independently, and to escalate when needed.
Responsibilities- Coordinate verification of baseline data in InSight across EMEA Regulatory Affairs teams; - Liaise with global and local stake holders to ensure alignment between global and EMEA expectations; - Provide colleagues with training, guidance and communication on the required verification activities; - Support multiple sites in verification activities as needed, including performing actual verification where appropriate and possible; - Liaise with Regulatory Affairs to ensure data verification feedback is assessed; - Liaise with data entry specialists to ensure data verification output is accurately entered in InSight.
Requirements• Good understanding of CTD Module 3 data; • Understanding of local registration data tracking requirements; • Knowledge of compliance requirements and advanced process thinking; • Proven ability to deliver complex projects on time; • Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level.
Other informationThis project will be for 8 months until the end of 2019, with a small chance of overrunning into 2020.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.