Kariéra

The leading independent Czech pharmaceutical company with its own scientific research base for development of human drug products is looking for a suitable candidate for the position of:

Medical Writer

Job description:

  • Perform medical writing activities that support preparation of regulatory & clinical documents required to support global drug development and registration activities
  • Cooperate with personnel from clinical, regulatory and scientific departments
  • Write, edit and review diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries and other medical/regulatory documents
  • Participate in the development of scientific manuscripts, abstracts, posters and slide presentations reporting clinical study data
  • Perform comprehensive literature searches and write peer-reviewed scientific publications
  • Ensure effective document management from start to finish (i.e. generation of a blank document to a final approved version)
  • Adherence to specific project timelines and budget
  • Ensure high-quality, accuracy and compliance of documents with SOPs, Good Publication Practice and ICH/GCP/regulatory guidelines
  • Provide required activities in a timely manner

Our requirements:

  • Master´s degree in Health Sciences is a must, Doctoral degree is a plus
  • At least 2 years of experience in a similar position within pharmaceutical industry
  • Ability to understand, interpret and communicate scientific data/information
  • Good understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, regulatory environment, project management and medical terminology
  • Knowledge of global regulatory publication guidelines (FDA, EMA, ICH, etc.) and best practices
  • Excellent communication, interpersonal and organizational skills
  • Ability to work effectively in a fast-paced environment with multiple high priority projects
  • Gastroenterology therapeutic area experience is preferred
  • Excellent English (written + spoken), Russian is a bonus
  • Good knowledge of MS Office

We offer:

  • Creative work in Czech pharmaceutical company with an international orientation
  • Attractive salary
  • System of company benefits (flexible working hours, meal vouchers, contribution for pension insurance, contribution for public transport, 5 weeks of vacation, meal vouchers, Multisport card)
  • Well-developed training system
  • Possibility of professional growth and development
  • Start date: immediately or by agreement

Kontakt

PRO.MED.CS Praha a.s.
Marie Moravová