Senior Medical Writer

Date posted:

Europital is an international organization dedicated to Medical Management and Scientific Research. We provide expert medical services in clinical research and drug development to our clients in the Pharmaceutical, Biotech and Medical Device industry.

Place of work: Ghent, Belgium

Roles and Responsibilities

  • Preparation, editing, formatting and finalization of the following documents:
    • Clinical documents; such as Protocol, Protocol Amendment, ICF, PIS, IB, CSR
    • Regulatory documents; such as IND, NDA (ISS/ISE), Briefing documents
    • Safety documents; such as DSUR, PSUR, ASR, Case Narratives
    • Scientific Publications; such as Manuscripts, Abstracts, White Papers
  • Interact with document authors, owners, contributors, and reviewers of various functional areas to ensure appropriate coordination of and input into medical writing tasks
  • Manage medical writing timelines for assigned documents to ensure on-time deliverables
  • Facilitate comment resolution with authors, reviewers, and project teams
  • May serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documents
  • Participate in the development of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables
  • Assist in the interviewing, mentoring, and integration of new medical writing staff

Qualifications and Experience

  • Relevant Scientific degree is required, advanced degree such as PhD, MD or PharmD is a plus
  • 5 years or more of medical writing experience in the pharmaceutical sector in a pharma, biotech or CRO
  • Project management experience is a plus
  • Prior experience in a variety of therapeutic areas, is preferred

Skills and Technical Proficiencies

  • Excellent writing skills with comprehensive knowledge of drug development process and applicable regulatory guidelines
  • Successful track record of working on complex clinical / regulatory writing projects
  • Attention to detail, multitasking, prioritization, and flexibility
  • Excellent communication skills with proven ability to interact in a cross-functional environment
  • Familiarity with EU and US regulatory requirements and guidelines for documents development with respect to structure, format, and content
  • Proficiency in use of MS Office and other relevant electronic systems
  • Demonstrated initiative and the ability to work independently

Our offer

  • Attractive salary
  • Excellent work atmosphere
  • Exciting and varied job with a lot of national and international interactions

How to apply

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