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Regulatory Affairs Data Verification Co-ordinator

2019-03-07 CLS Services | Leiden | WO / MBA | Fulltime | Sluit 2019-05-06

Do you have good understanding of CTD Module 3 data and are you in for a nice project for 8 months? Then we might be looking for you! We are looking for a Regulatory Affairs Data Verification Co-ordinator to co-ordinate and support data verification activities in our Marketing Authorisation ...

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Biologics B.V., we are searching for a Regulatory Affairs Data Verification Co-ordinator.

Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Job description
Do you have good understanding of CTD Module 3 data and are you in for a nice project for 8 months? Then we might be looking for you!

We are looking for a Regulatory Affairs Data Verification Co-ordinator to co-ordinate and support data verification activities in our Marketing Authorisation data tracking system InSight.
Your key responsibilities are:

  • Co-ordinate verification of CMC baseline data and MA baseline data in InSight across EMEA Regulatory Affairs teams, in close collaboration with the EMEA InSight Data Entry Specialists;
  • Liaise with the global RIM InSight team and CMC RA team on the data verification process, roles and responsibilities, to ensure alignment between global and EMEA expectations;
  • Provide GRA EMEA Local Operating Companies (LOCs) and Therapeutic Areas (TAs) with training, guidance and communication on the required verification activities;
  • Support LOCs in verification activities as needed, including performing actual verification where appropriate and possible;
  • Liaise with CMC RA to ensure EMEA verification feedback on CMC data is assessed and actioned;
  • Liaise with EMEA Data Entry Specialists to ensure EMEA verification output is accurately entered/reflected in InSight.


This role is critical to ensure the accuracy of EMEA data in InSight. The successful candidate should be able to effectively drive decisions and enforce actions in a process which is still developing, take appropriate EMEA decisions independently and escalate when needed.

Who we're looking for
The ideal candidate has a good understanding of CTD Module 3 data and local registration data tracking requirements. You have knowledge of compliance requirements and you have excellent cross-cultural communication skills in English. Are you the pro-active Regulatory Affairs Data Verification Co-ordinator we are looking for?

Additional vacancy information
Reference: A1900031
Contract: Temporary contract with CLS Services
Education: WO/MSc.
HBO/BSc.
PhD.
Terms: Full time preferred, 32 hours discussable. Leiden office or home-based with 1 trip to Leiden per week/2x per month. Must be flexible for incidental travel (10%). Fixed term assignment (8 months) with some possibility of overrunning in 2020.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555



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