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Jefferson Wells
Jefferson Wells

Clinical Research Regulatory Coordinator

Published on Jobat.be 14 days ago

Clinical Research Regulatory Coordinator

Clinical Research Regulatory Coordinator

Our partners innovate to bring treatments to their patients that significantly improve their lives.?Together with the government and other health partners they are working towards qualitative, affordable and accessible healthcare.

The Regulatory Coordinator is responsible (primarily or in supporting role) for all activities related to the submissions to Ethics Committee(s) and Regulatory/Competent Authorities. In addition, responsibility includes creating, initiating, coordinating, monitoring and maintaining clinical study site documentation.

 

 

Job description

Ethics Committee Activities:

  • Solicit input from clinical teams on assigned synopses, protocols and Informed Consent Documents (ICDs) where appropriate
  • Ensure the accuracy of managed ICDs and their translations, as well as related regulatory documents for assigned protocols
  • Responsible for preparing CTA submissions to Ethics Committee(s)
  • Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidances and regulations/laws.
  • And more

Regulatory Authorities Activities:

  • Responsible for preparing CTA submissions to Competent Authorities
  • Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidances and regulations/laws.
  • Coordinates with PCRU Pharmacists, RegCMC and Dev Ops colleagues to ensure timely and accurate submission of studies to the Competent Authorities
  • Lead the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), and ensure communications to CA
  • Ensure end of study reports are provided in time to Regulatory Authorities.

Other Activities:

  • Responsible for study-specific tasks such as site registration in CTMS/Oracle Siebel and Shared Investigator Platform (SIP), QC and filling of study documents in PTMF as well as maintenance and archiving of study files (ISF)
  • Act as an SME for SOP updates and review within the functional line
  • Responsible for providing oversight on specialized regulatory related PCRU projects
  • Liaison to the project teams for studies scheduled in the PCRU to provide inputs on regulatory aspects;
  • Responsible for the implementation of new processes and work to proactively resolve issues where appropriate
  • Develop knowledge of the GDPR and optimize its implementation at the PCRU
  • Lead PCRU teams in accomplishing business needs and resolving issues
  • Represent the PCRU on local or global initiatives as a subject matter expert where appropriate
  • Develop and maintain relationships with schools and universities for training site registration
  • Give input in PCRU documentation to facilitate positive attitude and trust of participants toward clinical research
  • Participate in training courses as appropriate, and train Regulatory team members with less experience and expertise

 

 

Profile

Who are you?

  • Bachelor’s/ Master degree in management, Life Sciences or equivalent, with relevant experience in Regulatory Affairs
  • Languages : Fluent in French, Dutch and English (written and spoken)
  • Autonomous but with a strong team spirit
  • Strong understanding and knowledge of regulatory aspects of drug development
  • Accountable, with very keen sense of initiative and leadership skills
  • Strong organizational skills, multiple projects flexibility and very good resistance to stress or a high workload
  • Detail oriented, precise in oral and written communication
  • Strong IT skills: advanced use of MS Office tools such as Outlook, Word, Excel, PowerPoint, Teams, OneNote.
  • Min. 5 years of experience in pharma, of which at least some years in a regulatory environment

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.?

 

Are you interested? Apply now with your cv!

Offer

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.?

 

Are you interested? Apply now with your cv!

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    14 days left to apply

    Characteristics

    Requirements

    • Professional bachelor (Higher Education Short Type)
    • Dutch

    Offer

    • Full-time
    • Group insurance
    • Company car
    • Petrol card
    • Meal vouchers
    • Individual hospital insurance
    • Family hospital insurance
    • Eco Cheque
    • Training
    • Remote work

    Apply before

    • 11 November

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