Principal Medical Writer

Group: Medical Writing

Reports to: Executive Vice President, Chief Scientific Officer

 

Responsibilities Include:

The Principal Medical Writer independently plans and prepares a variety of clinical
documents necessary for all phases of clinical drug and device 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. Acts as a mentor for the junior members of the
Medical Writing department. 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 8 to 10 years of medical writing
experience in a CRO, pharmaceutical, or biotechnology setting. Other
professional and/or educational experience may contribute toward this minimum
requirement, as determined on a case-by-case basis.
• 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