Medical Writer - Sponsor dedicated
Lisbon, Portugal
há 3 dias

Job Oveview

Provides scientific / regulatory guidance and technical expertise in the writing, production, and review of regulatory and other scientific / clinical documents.

Serves as medical writer on clinical study. Plans and coordinates report-writing activities with dependent staff roles to ensure satisfactory completion of all writing projects, as well as mentors and leads less experienced medical writers on complex projects

Job responsibilities :

  • Compiles, writes, and edits medical writing deliverables
  • Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas, in specific study synopsis, study protocol, abstracts, poster and manuscripts.
  • Advises study teams on data presentation and production strategies and on data interpretation as needed.
  • Interacts with cross-functional team, data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Reviews statistical analysis plans and table / figure / listing specifications for appropriate content, and for grammar, format, and consistency.
  • Serves as peer reviewer on internal review team.
  • Established regulatory standards, including but not limited to ICH-E6 guidelines, as well as company SOPs, approved templates when completing medical writing projects, on-time and on-budget.
  • Performs on-line clinical literature searches, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Essential Qualifications

  • Background in a scientific or medical discipline.
  • At least, 1.5 years of experience as a Medical Writer in Clinical Research
  • Extensive knowledge of English grammar with a familiarity with a standard style guide
  • Ability to communicate scientific or medical information in a clear and concise manner
  • Familiarity with the principles of clinical research
  • Ability to interpret and present clinical data
  • Advanced degree within the field
  • Professional certification
  • Understanding of multiple aspects within Study Management
  • Officebased
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