POSITION SUMMARY: The Assistant Medical Writer assists in preparation, development, Quality Control (QC), and review for accuracy of Clinical Study Reports and related materials for submission to clients, the FDA and other regulatory agencies.
Assist in reviewing/QC tables and listings for completeness and accuracy as document preparation for Clinical Study Reports.
Assist in QC for accuracy of Clinical Study Reports sections and publications.
Assist in reviewing/QC for accuracy of various documents (including clinical protocols) to support all phases of clinical product development.
Keep updated guidelines and requirements of the FDA, and other regulatory agencies for reference in the development of required documents, including ICH Guidelines.
Work with outside and internal database managers and statisticians to obtain data listings and analyses needed to support the preparation of Clinical Study Report/publications.
Review reports, tables and listings for completeness and accuracy.
Assist as a member of the study teams and clinical project teams.
Assist in the interaction with various departments to collect study information.
Other duties as assigned.
REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's degree (biology. chemistry, or mathematics disciplines preferred)
Extremely detail-oriented with excellent follow-up skills.
Strong verbal and written communication skills.
Strong Microsoft Office skills particularly in MS Word and Excel.
Effective interpersonal skills, including the ability to work in a team environment, contributing to a collaborative work atmosphere.