Technical Integrator Dossier Development

  • Randstad
  • 6000.00 - 8000.00
  • uren
  • Master degree

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world.

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence. They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

functie Vereisten

  • PhD Biochemistry, Pharmacy or related with Post-doc experience and 6+ years relevant experience or University degree with 8+ years relevant experience.
  • Extensive experience with Module 3 CMC dossier development.
  • Experience in scientific regulatory writing in Documentum based systems.
  • Great communicator.
  • Expertise in appropriate CMC regulatory applications.

Wat krijg je?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Werkzaamheden

  • Develop the technical eCTD sections to support Regulatory CMC dossier applications.
  • Coordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions.
  • Coordinate the timeline, virtual document and the generation of the Quality module.
  • Represents the department on multi-functional project development teams to support regulatory filings.
  • Author sections of the CMC dossier and evaluates.
  • Ensure that final versions comply with regulatory requirements and fulfill regulatory agency expectations.
  • Support the technical functions in the development of responses to health authority inquiries.
  • Support clinical trials as well as major applications.
  • Evaluate and ensure the completeness, accuracy and compliance of data provided for all regulatory submissions.
  • Ensure all Quality submissions are completed in a timely manner.

TAGCLOUD

dossierdevelopment
#regulatory
#module3
#CMC
#technicalintegrator
Peter Debrichy

Geïnteresseerd?

Send your resume to peter@tailorminds.com referring to job id (936)

Meer informatie?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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