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Principal (Regulatory) Medical Writer

  • Job type: Permanent
  • Location: Amsterdam
  • Salary: Competitive
  • Job reference: RTGW939595
  • Sector: EPM Scientific, Regulatory
  • Date posted: 14/03/2018
Principal (Regulatory) Medical Writer

Amsterdam, Netherlands


A leading Pharmaceutical company is seeking an experienced Medical Writer based in Amsterdam, Netherlands. This global organisation is seeking to expand their Medical Writing team following a strong period of growth.  The Senior Medical Writer will enjoy great autonomy in their work as well as exposure to leadership responsibility as they mentor less experienced writers in the team. 


This international organisation specialises in oncology, infectious diseases and respiratory any candidate will be expected to possess experience in core and/or niche therapeutic areas.

Responsibilities:


  • Research, write and edit clinical documents by applying functional expertise and clinical drug development knowledge.
  • Contribute to a single team which guides medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions.
  • Provide more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications and lead the writing strategy providing expertise including organization, content, timelines, and resource requirements.
  • Provide review and substantive editing of contributions, and ensures resolution of issues.
  • The Senior Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.
 
Skills and Experience Required:

  • Degree (or equivalent) in science, health profession, or journalism required.  Masters or PhD level degree ideal.
  • Substantial experience writing for a pharmaceutical or biotechnology company essential – 7 years in industry  
  • Previous experience as key writer for key documents included in major international regulatory submissions is preferred
  • Knowledge and evidence of experience in writing within core and/or niche therapeutic areas imperative.
  • Experience managing writing activities for a major international regulatory submission (project or people management) is desired.

Package:

  • Competitive Salary
  • Ongoing training programme provided
  • Career development plan
  • Flexible working – including WFH arrangements
  • Private healthcare and life assurance
  • 33 days holiday (inclusive of bank holidays)
  • Group pension plan
 

How to apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: robert.gwillim@epmscientific.com or phone +442037588791


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