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Title: Medical Writer
Job listing published: 7/29/08
Location: San Diego
Department: Medical Regulatory Affairs
Contact: To apply for this position, please email your resume to Synteract Jobs.
Description
You will write, edit and review documents for drug, biologic and device development according to global agency guidance, templates, style guides, and Standard Operating Procedures. These documents may include Investigator Brochures, clinical protocols and amendments, clinical study reports, package inserts, Integrated Summary of Safety reports, Integrated Summary of Efficacy reports, IND applications, IDE applications, NDA, BLA and PMA submissions. In addition, you will Interpret clinical study results; write, review and edit clinical study reports, protocols, documents for regulatory submission, investigator brochures, or other clinical and regulatory documents. You?ll peform QC on clinical documents prepared by other writers and assist in the development of formats and guidelines for clinical documentation. Other responsibilities may include developing and implementing training of medical writers and writing/ editing Standard Operating Procedures.
You should have an advanced degree in a scientific, medical or statistical discipline and at least 2 years? experience writing clinical study reports or related materials. Requires knowledge of medical conditions or ability to assimilate such knowledge quickly, familiarity with medical terminology and clinical experience. Must have intermediate proficiency in MS Word, MS Excel, PowerPoint and Adobe; advanced knowledge of MS Word is preferred. Knowledge of ICH and FDA report guidelines and Good Clinical Practices is required and familiarity with CTD/eCTD format highly desired.
For immediate consideration, please send your resume or CV to jobs@synteract.com . Please reference "Medical Writer" in subject line when applying.
