Senior Medical Writer

About the role

The Senior Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary 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.

Responsibilities

• Organize, analyze, interpret, and present scientific and statistical information in compliance with ICH and other regulatory guidelines.
• Collaborate with cross-functional internal and external document production teams to ensure the quality and accuracy of medical communications.
• Work under the direction of Medical Writing management to develop and implement strategies for regulatory document preparation.

Requirements

• Bachelor’s degree required; science-related field preferred.
• Minimum of 5 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting.
• 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.

Qualifications

Bachelor’s degree required; science-related field preferred. Minimum of 5 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. 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.

Skills

• 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, including advanced Microsoft Word proficiency.

Benefits

Benefits vary by location and may include:

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

Pay

Pay varies by location and position.

Schedule

Schedule varies by location and position.

Veristat

Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. Learn more about our core values here!