Regulatory Affairs Data Verification Coordinator

Bedrijfsnaam: -
Plaatsingsdatum: 08/03/2019
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.The CompanyThe company is a multinational manufacturer of medical devices.

Role DescriptionWe are looking for a Regulatory Affairs Data Verification Coordinator to coordinate and support data verification activities in our Marketing Authorisation data tracking system 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.

Responsibilities- Coordinate verification of CMC baseline data and MA baseline data in InSight across EMEA Regulatory Affairs teams (Local Operating Companies LOCs and Therapeutic Areas TAs), under the oversight the EMEA RIM InSight Implementation Lead and 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 LOCs and 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.

Requirements- Good understanding of CTD Module 3 data
- Understanding of local registration data tracking requirements
- Knowledge of compliance requirements and advanced process thinking
- Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.




Plaatsingsdatum :
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9723 HK
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Nader te bepalen
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< 1 jaar (starter)
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