Overview
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. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill Estelle®, Mithra is now focusing on its second product 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.
We are looking fo a Medical Writer to join our R&D department at our Liege Office.
Responsibilities
1. Actively take part in the writing, reviewing and editing of:
- Clinical study related documents: clinical study synopses, clinical study protocols and amendments, clinical study reports, informed consent forms, investigator brochures, statistical analysis plans, etc…,
- Briefing books for regulatory agencies (scientific advice, pre-submission meetings, etc …),
- Clinical modules of new drug applications and marketing authorization applications: biopharmaceutics, clinical pharmacology, integrated summaries of efficacy and safety, clinical overview,
- Answers to questions from regulatory authorities,
- Medical writing procedures and templates, ensuring compliance with applicable regulatory guidelines and good practices.
2. Produce documents of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency.
3. Adhere to regulatory guidelines (ICH-GCP and any applicable standards) and to company SOPs.
4. Participate in Clinical Development Team meetings and Clinical Study Team meetings.
5. Work in a team environment and coordinate with the team and other departments to move documents forward to completion.
Qualifications
6. A minimum of a Master's degree in a scientific discipline (a degree in biological, pharmaceutical or medical sciences is highly preferred)
7. Minimum 3 years of experience in regulatory medical writing (clinical study reports, protocols, informed consent forms,…)
8. Experience with principles of clinical research and with interpretation and presentation of clinical data and other complex information
9. Excellent grammatical, editorial and proofreading skills (in English).
10. Committed to deliver excellence, be pro-active
11. Strong proficiency in computer processing programs (Microsoft Office, Sharepoint)
12. Strong interpersonal and communication skills
13. Team player
Options