|
MS14918 - SR. MEDICAL WRITER
Ensure, directly or indirectly, in writing themselves or by leading several contributors and CROs, high quality easy to read and to understand, and well prepared scientific, clinical and regulatory documents with the appropriate formats according to the goals, the audience targeted and the regulations and/or novelty of findings, increasing the intellectual property of the company. In addition, by providing the own scientific expertise that of the Medical Writing and Document Management group to Global Clinical Development, input ideas and methodologies in order to support the Department priorities.
Major Accountabilities:
Write and/or critically review/edit documents for regulatory submissions (CSR, ISS, ISE, clinical summary and clinical overview)
Write and/or critically review/edit documents to scientific/clinical expertise (eg. Investigator's Brochure)
Select/coordinate and manage appropriate contributors for performing these tasks.
Review of study-level draft Protocols and draft SAPs ensuring all information required for the CSR, ISS, and ISE will be presented appropriately.
Participation in internal meeting as required (e.g. Clinical Satellite Teams or Clinical Study Teams) for Development products providing Medical Writing input for the preparation of Clinical Study Reports.
Collaborate cross-functionally and globally to coordinate the different experts involved into the clinical study report process and other regulatory documents, in order to facilitate inter-and intra-departmental flow of scientific/clinical information and increase the quality and the consistency of the documents.
Provide, maintain and develop strong scientific/clinical expertise to increase value of the company's projects.
MS Degree required.
Submit Your Resume
|
