This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Analysis of data and preparation of ad hoc reports/plans in the framework: PADER
Risk management plan
Benefit / risk evaluation report
Signal detection and reporting
PSUR / PBRER / Addendum to Clinical Overview
DSUR
Off label use reports (French requirements)
PSUSA response
Literature screening for medical writing reports
Ad hoc reports from regulatory authority
Review of Medical Writing Reports
Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis
Production and validation of safety reports
Medical training for staff from other divisions
Participation in the drafting of quality documents related to the Medical writing specific activities
Ensure adherence to GVP (French and European), ICH guidelines, other applicable guidelines, SOPs, and client templates
Understands and interprets clinical and scientific reports
Interprets and presents scientific data
Analyses clinical evidence of all kinds
Understands levels of evidence required to achieve regulatory and goals
Selection and Analysis of literature data based on the results of literature searches
Provides timely, accurate, appropriate and clear verbal and written information in response to enquiries
Prepares planning for aggregate reports for clients and shares it with QPPV / client as applicable
Responsible for client coordination & participation in audit & inspection to represent medical writing function
Supports in CAPA proposal & implementation
Prepares & review client technical agreement
Supports in effort estimation for new RFP & participate in Bid defense meeting
Supports the Senior Medical Writer and the Service Area manager/ director/team leader in reviews metrics to assess accuracy, quality and regulatory compliance
Participates in training as required for ProductLife Group
Complies with the company’s policies and procedures
Requirements
Pharmacist or physician residing and operating in France
Minimum 5-8 years of experience in a PV department (preferentially in a Medical Writing department)