Principal Medical Writer- Clinical Focus

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. Responsibilities include 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 role reports to Medical Writing management and collaborates with cross‑functional internal and external document production teams.

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

• 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.
• Experience leading submission‑level sections (e.g., Clinical Study Reports, Protocols, Investigator Brochures, Integrated Summary of Safety and Integrated Summary of Effectiveness).
• Strong ability to direct and coordinate teams toward common goals within timelines and budgets on complex projects.
• Broad experience and technical expertise across more than one therapy area, with the capacity to transfer knowledge organization‑wide.
• Advanced knowledge of ICH and related regulatory guidelines.
• Excellent written English and keen attention to detail.
• Strong interpersonal and communication skills.
• Advanced proficiency in Microsoft Office Suite, especially Microsoft Word.

• 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 in accordance with local regulations.
• 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.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Veristat provides equal employment opportunities to all employees and applicants for employment without regard to age, disability, genetics, gender identity or expression, gender reassignment, marriage and civil partnership, pregnancy and maternity, race (including color, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, source of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices.