Medical Writer
General Summary:
The Medical Writer will produce clinical study reports summarizing data from clinical studies.
Primary Responsibilities:
· Prepares clinical study reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration (FDA) and the World Health Organization (WHO) for publication and/or presentation.
· Assists in the development of formats and guidelines for clinical documentation.
· May prepare scientific manuscripts, abstracts and posters.
· May also support clinical research associates and medical doctors in clinical protocol development.
· Maintains professional knowledge & expertise by attending and/or participating in seminars and conferences.
Qualifications:
A scientific degree (Ph.D. preferred) with 5-8 years relevant experience in a biotech/pharmaceutical setting Working knowledge of FDA and ICH (International Committee on Harmonization) guidelines for industry-standard document templates and reporting designs. Ability to determine methods and procedures on new assignments, and may provide guidance and oversee the activities of other lower-level personnel.
Send resume to hr@favrille.com or FAX to 858-597-7040