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Tip oferta Job
Nivel cariera Entry, Middle
Oras(e) Timisoara  Vezi pe harta
Domenii oferta
Sanatate
Sanatate
Farmacii
Chimie / Biochimie
 

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

Requirements

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

Intra in cont