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Merck Serono S.A. Geneva
- Senior Medical Writer
2010 - maintenant
For the assigned projects in Neuro-Degenerative Disease TA:
- Oversee document preparation activities
- Build and maintain knowledge base to improve the overall medical content of documents.
- Mentor and train writers.
- Write and/or review reports, protocols, amendments, and regulatory submission documents.
- Contribute to preparation of Investigator Brochures.
- Attend appropriate Trial Team meetings and assume team responsibilities.
- Review statistical analysis plans. Ensure appropriate incorporation into reports.
- Drive the clinical study report writing process.
- Develop writing tools such as style manuals and templates.
- Prepare, review and edit publications.
- Ensure Quality Control review of protocols, protocol amendments, Clinical Trial Reports, Investigator Brochures and regulatory submission documents.
- Work effectively with other staff in Global Clinical Operations (e.g., Global Biostatistics, Therapeutic Directors, Global Drug Safety, Clinical Trial Management, Data Management, Clinical Monitoring) in team situations.
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Solvay Pharmaceuticals
- Senior Medical Writer
2003 - 2009
Authoring / full coordination of clinical and regulatory support documentation (Protocols, CSRs, IBs, eCTD components, Annual Safety reports, PIP, Publications)
Editing, proofreading and coordination of outsourced documents
Development and maintenance of standards and processes
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Mapi
- Senior Medical Writer
Lyon
1999 - 2003
Management of Medical Writing (internal and external) resources
Editing, proofreading and coordination of Medical Writing delivered documents
Authoring of clinical, epidemiological, quality of life and pharmaco-economics documents
Development and maintenance of standards and templates
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Mapi
- Medical Writer
Lyon
1996 - 1999
Authoring of clinical, epidemiological, quality of life and pharmaco-economics documents
Development and maintenance of standards and templates
Project Management: follow-up of project progress on OPX2 Software
See examples
