Remote Medical Writer II/III

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ERGOMED

📍Remote - Romania

Job highlights

Summary

The Medical Writer II/III position at PrimeVigilance is an opportunity for career advancement in drug safety. The role involves independent authoring, editing, and reviewing regulatory/clinical documents, participating in trainings, and supporting pharmacovigilance operations associated with medical writing.

Requirements

  • Previous experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing
  • Pharmacist or MD, life science MD
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail
  • Ability to effectively train and mentor Associate Medical Writers
  • Advanced knowledge of English

Responsibilities

  • Independent authoring, editing, and reviewing of various regulatory/clinical documents (e.g. aggregate reports, risk management plans and other documents needed throughout the product’s life cycle)
  • Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing
  • Support in all pharmacovigilance operations associated with medical writing
  • Continuous self-education in all aspects associated with medical writing

Benefits

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language

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