| Date de publication | Type de poste | Lieu de travail | Expérience | Étude | Disponibilité | Langues | Mobilité |
| 15 juillet 2021 | CDI | Cite El Khadra, Tunis, Tunisie | Entre 1 et 2 ans | Doctorat | Plein temps | Anglais | International |
Description de l’annonce:
We are looking for a Medical Writer to have responsibility for allocated tasks within Medical Writing Platform.
- Contribute to Medical Writing activities within the Medical information and vigilances Business Unit.
- Prepare, reviews and provide feedback for safety reports including: Signal detection, Risk Management Plans (RMPs) Addendum to Clinical Overviews (ACOs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs) and Development Safety Update Reports (DSURs).
- Contribute to the production of client administrative documents to be included in regulatory submissions (i.e. Briefing packages to HAs, Ethics Committees documentation).
- Assist in the preparation of Standard Operating procedures (SOPs) and Working Practice Documents.
- To ensure adherence to GVP, ICH guidelines, SOPs, and client requirements.
Education
Bachelor’s degree in pharmacy; physician or scientific;
Experience
- Proved medical writing experience;
- At least 2 years of Signal detection working experience
Skills
- Process oriented with good attention to detail
- Excellent organizational skills
- Experience in signal detections, RMP, PSURs and DSURs
- Fluent in English for daily contacts