Vacancy Medical Writer – Utrecht


Organization

25 OCT ’21: For a clinical-stage Biopharmaceutical company close to launching their first product, we are looking for a Regulatory Medical Writer. The current focus is on funding and executing the Phase III/registration trial and preparation for launch. Besides that, Operational Excellence and flawless execution of pivotal studies with the objective to deliver a quality market authorisation submission package. The bandwidth of the organisation allows for expanding the pipeline and accommodating new strategic opportunities.

Function

As a Regulatory Medical Writer you support the global drug development and registration activities by:

  • Taking responsibility for writing, editing and reviewing regulatory and clinical documents in English including IB updates, SA briefing documents, module 2 clinical (and non-clinical) documents informed consent, study protocol, clinical study reports, SAP review, answers to HA questions)
  • Managing quality, accuracy and compliance of regulatory and clinical documents with internal and external standards
  • Focusing on document management by ensuring that all legacy documents are available or requested from third parties and you actively contribute to making them filing-ready regarding document availability
  • Performing literature searches and reviews as necessary incl. drafting and updating of SmPC’s, USPIs and patient leaflets
  • Acting as document management system contact for the organisation; taking ownership of our Document Management system, which is part of our QMS
  • Working closely together with the colleagues from Clinical, Medical, Regulatory and Scientific departments
  • Reporting directly into the VP of Regulatory Affairs & Quality Management

Requirements

We expect our Regulatory Medical Writer to have:

  • A Biomedical degree (Pharmacology, Biology, Chemical Engineering etc.)
  • Relevant experience in Regulatory Medical Writing
  • Excellent interpersonal, verbal and written communication skills
  • The ability to plan, organise, prioritise and execute multiple tasks within assigned objectives
  • The ability to work effectively in an international matrix team and value the importance of teamwork
  • Steady nerves; you can deal with peaks in the planning, a high workload and the ad-hoc and fast paced nature of biotech
  • Fluent knowledge of English (written and oral)
  • Advanced knowledge of MS Office (Word, PowerPoint, Excel)

Offer

For your time and energy, the organisation likes to offer:

  • A high standard organisation with dedicated co-workers
  • A committed team of matured professionals who foster a healthy work culture
  • Salary range of around €95,000.- gross per year depending on experience
  • Fully covered pension and other excellent secondary benefits
  • Visa sponsorship and relocation package

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Yvo Selderbeek
Senior Associate | Clinical Research

+31 6 12 57 66 48
+31 23 754 86 60
y.selderbeek@qtcrecruitment.com