Medical Writer

Nivel cariera

Entry (0-2 ani), Middle (2-5 ani)

Limbi vorbite




Role and responsibilities

  • Developing content and writing of medical/scientific documents for regulatory purposes, especially Risk Management Plan, Addendum to Clinical Overview, PSUR and Clinical Overview

  • Editing, quality assurance and formatting of above mentioned documents


Key competencies

  • Technical writing skills balanced with ability to convey complex information

  • Research and analysis skills e.g. ability to undertake literature reviews

  • Ability to research, write, edit and proof-read scientific documents

  • Ability to interpret and summarize scientific publications and clinical data

  • Ability to draft original text with a high level of accuracy to source data, ensuring consistency and readability

  • Ability to draft according to specific style and format guidelines in order to convey clearly defined messages

Others (not essential but would be an advantage)

  • Knowledge of the pharmaceutical industry and drug development process

  • Knowledge of regulatory requirements for pharmaceutical products

  • Familiarity with clinical trial design and statistics

Education and experience

  • University degree in medicine, pharmacy or natural science (biology/chemistry)

  • Doctorate (MD/PhD)

  • Experience in writing of scientific documents

  • Relevant postgraduate qualification

  • Ideally practical clinical experience or relevant experience in pharmaceutical industry (medical writing/regulatory affairs)

Language skills

  • Fluent written and spoken English essential

Computer skills

  • MS Office

  • Research in internet data bases like PubMed or Embase

  • Familiarity with Reference Manager would be useful