Submission Specialist - CRO

  • Location

    Amsterdam, North Holland

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    €45000 - €60000 per annum

  • Contact:

    Carlos Biggemann

  • Contact email:

    Carlos.Biggemann@volt.eu.com

  • Job ref:

    77905-PHARM-CBG_1612258929

  • Published:

    10 maanden geleden

  • Duration:

    permanent

  • Expiry date:

    2021-04-03

  • Startdate:

    ASAP

Responsibilities:
*Collect information on country specific application procedures
*Determine the format and content of application packages to be submitted to any kind of authoritative body
*Write master- and country versions of the Patient Information and Consent Forms
*Develop and update trackers listing regulatory information, timelines, status, correspondence, and requirements
*Prepare, process and finalize submission documentation in collaboration with study teams and clients
*Liaise with other departments and external parties (e.g., translation vendors) for required submission documents
*Follow up on Clinical Trial Application / submission procedures (e.g., validation correspondence, deficiency letters, requests) in consultation with study teams and clients
*Assess and review regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory and start-up intelligence
*Assist the project teams and clients in ensuring regulatory compliance during the complete lifecycle of clinical projects
*Provide regulatory advice to study teams and sponsors

Qualifications:
*Life science, healthcare and/or business degree
*Minimum 2 years of relevant work experience
*Minimum 2 years of experience in drug development and/or clinical research
*Thorough knowledge of ICH-GCP(R2), privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and/or applicable local regulatory requirements