Senior Medical Writer

Group: Medical Writing

Reports to: Vice President, Clinical Operations

Responsibilities

The Senior Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include clinical study reports, study protocols, investigator’s brochures, and manuscripts. Conducts overall planning of the clinical sections of global submissions. Works with manager to develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy. Advises management regarding project resource requirements, and manages project-related activities of resources assigned. Reviews statistical analysis plans and case report forms, as required. 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. Works independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization.

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 5 years of pharmaceuticals, biotech, or CRO medical writing experience.
• Skills:  Working knowledge of ICH and other regulatory guidelines required.  The ability to accurately and clearly present clinical data, strong verbal, written, and interpersonal communication skills, and proficiency in MicroSoft Word required.  Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred. 
• Excellent regulatory writing skills (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