Medical Writer

Group: Writing

Reports to: Associate Director, Medical Writing

Responsibilities

The Medical Writer drafts and finalizes documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include, but are not limited to, clinical study reports, study protocols, investigator’s brochures, and manuscripts. Responsibilities include: Works with Project Manager to develop timelines and resource plans for the production of clinical documents. Reviews statistical analysis plans and case report forms, as required. The Medical Writer performs quality control (QC) review of clinical study reports and other submissions written by other medical writers. Keeps management informed on progress documents and other project related information, assist management in projecting resources, and perform administrative duties as requested.

Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards.

Minimum Requirements

• Minimum Education: BS/BSc/BA in a science or industry-related discipline.
• Minimum Work Requirements: Minimum of 2 years of medical writing experience in a contract research organization (CRO), pharmaceutical, or biotech setting.
• Skills: Working knowledge of ICH and other regulatory guidelines. Broad knowledge of global pharmaceutical regulatory requirements, and experience in clinical research or other areas of the pharmaceutical industry. The ability to accurately and clearly present clinical data as well as strong verbal and interpersonal communication skills. Proficiency in Microsoft Word is required.
• Writing (e.g., English usage) and a keen attention to detail also are required.

Submit Your Resume

If you would like to be considered for a position at Veristat, please submit your resume to Human Resources at hr@veristat.com