Medical Writer

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.

Experience

• Proved medical writing experience;
• At least 2 years of Signal detection working experience