Medical writer

작업 내용

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment for perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO.

Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is headquartered in Liège, Belgium.

• Actively take part in the writing, reviewing and editing process of clinical essential documents such as:
  • Investigator Brochures
  • Clinical Study Reports
  • Clinical Trial Protocols
  • Clinical Summaries of Efficacy and Safety and Clinical Overviews
  • Preparation of regulatory documents, such as company positions for scientific advices with the competent authorities
  • …
• Produce documents of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency.
• Adhere to regulatory guidelines and company styles and processes.
• Participate in project-related meetings and teleconferences
• Work in a team environment and coordinate with the team to move documents forward to completion

• A minimum of a Master’s degree in a scientific discipline (a degree in biological or medical sciences is highly preferred)
• Minimum 3 years of medical writing experience
• Have already published written scientific articles
• Excellent written and verbal language skills in English
• Able to perform comprehensive literature reviews
• Able to create Power Point presentations
• Committed to deliver excellence, be pro-active, have a strong team focus
• Proficiency in computer word processing programs
• Strong interpersonal and communication skills as the individual