Principal Medical Writer- Clinical Focus

Job Description:

Key Purpose:
The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.

Experience & Minimum Requirements:

• Bachelor’s degree required; science-related field preferred.
• Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
• Ability to lead submission-level sections (clinical documents, e.g., Clinical Study Reports, Protocols, Investigator Brochures, Integrated Summary of Safety and Integrated Summary of Effectiveness) taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects.
• Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization.
• Advanced knowledge of ICH and related regulatory guidelines.
• Excellent written English and keen attention to detail.
• Strong interpersonal and communication skills.
• Experience with Microsoft Office Suite is essential, including advanced Microsoft Word proficiency.

Additional Requirements:

• Driving/Travel requirements – 0-10% (national and international)
• Physical requirements – ability to occasionally lift/move up to 25 lbs
• Hours/Conditions – minimum weekly work hours set in accordance with local regulations
• Fair Labor Standards Act Classification – Exempt

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.