Medical Writer F - M H/F Astek

Your mission (should you decide to accept it):

Your potential challenges will be various, depending on the clients' priorities. The list below gives you examples of our classic activities.

Your daily activities will be:

- Synthesize literature review findings into reports in various therapeutic area ;
- Write, edit and update clinical development related documents with the highest level of technical accuracy (clinical protocols, informed consent forms, study reports, investigator brochures, clinical trial results, annual reports, statistical analysis plans, briefing documents, paediatric investigational plans and other clinical documents) ;
- Lead the process of critical review of clinical documents and incorporate multiple reviews into successive drafts. Provide quality control (QC) support for clinical documents as needed ;
- Ensure the quality of clinical documents by maintaining and promoting familiarity with International Council on Harmonization Good Clinical Practice (ICH-GCP) guidelines, and other standards ;
- Liaise with authors and clients regarding scientific content ;
- Write, review and edit manuscripts, posters, abstracts... ;
- Attend internal and external team meetings ;
- Respect quality commitments ;
- Participate in the continual improvement of the Quality System ;
- Identify, record and ensure corrections of non-conformities ;
- Update the Medical Writing process and templates and ensure compliance with current regulatory guidelines and best practice ;
- Assist with the development of business proposals related to Medical Writing functions (preparation of budget grids and financial and technical proposals for clients).

And some more technical jobs in Medical Writing might also require:

- The writing of price and reimbursement files for the authorities and working in tandem with a Value and Patient Access Manager.
- Most of the content for the file will be delivered, but occasionally additional literature searches may be needed.