Candidates

Medical Writing

There are different types of Medical Writing roles that are often split into two areas:

  • Medical Communications

  • Regulatory / Clinical Writing

Medical Communications Writers will often produce high quality creative material that is used in product launches and public relations or sometimes training. Although these roles do exist in Pharmaceutical companies they are more likely to be for a Communications or PR Agency.

Regulatory or Clinical Writers will be more involved in the production of Clinical Study Reports (CSR’s) or Common Technical Documents (CTD’s). You may also be involved in the Quality checking of other writers’ work.

Although it is not essential, Medical Writers will often have done a PhD as this demonstrates that you have good written skills and an ability to understand complex scientific information. Good communication skills both written and verbal are essential for this role and often throughout the recruitment process you will be asked to complete a medical writing test.

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Job of the week - Senior Contract Regulatory Professional

Our client is a leading Pharmaceutical company. This R&D group have a large and dynamic European Regulatory Affairs Department responsible for the regulatory affairs work for the CNS R&D in Europe, Turkey, CEE region, Israel, South Africa, New Zealand and Australia.

The work has several aspects;

  • Communication to the Global Regulatory Teams and the supporting functions for regulatory submissions, such as clinical;
  • Working with the local operating companies within the^allocated region and external communication to regulatory authorities in the regions and to the EMEA. The group covers both developmental compounds not yet licensed and the maintenance and further development of marketed products. The prime responsibility for compounds is with the European Regulatory Liaison (EURL) who is responsible for the regulatory activities in the region and inputs to the global regulatory aspects for the compound.Regulatory consultants will work for an EURL or a global regulatory leader in the CNS therapeutic area or in the mature products area. They will work on the practical aspects of the compounds assigned from clinical trial applications (CTA’s), ASR’s, requests for scientific advice, MAA preparation, variations, renewals, PSURs etc depending on the life cycle of the compounds assigned. They may work on one or several compounds depending upon the work required for any compound at the time. Their work will be assigned and monitored by the EURL or theglobal regulatory lead responsible for the consultant.Eligibility to work in the EEA is required