Principal Medical Writer – Clinical Focus

This is a fully remote position, open to applicants in United States, +2 more states.

📋 Description

• Plan and prepare regulatory documents and medical communications independently to support all stages of product development.

• Organize, analyze, interpret, and present scientific and statistical data in accordance with ICH and other regulatory standards.

• Create documents following the company's established documentation standards.

• Operate under the guidance of Medical Writing management.

• Collaborate with both internal and external cross-functional teams for document production.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in a science-related field.

• At least 7 years of experience in medical writing within a contract research organization or a pharmaceutical/biotechnology research environment.

• Other relevant professional and/or educational experiences may be considered on a case-by-case basis to meet the minimum experience requirement.

• In-depth understanding of ICH and associated regulatory guidelines.

• Proficient in written English.

• Strong attention to detail.

• Excellent interpersonal and communication skills.

• Experience with Microsoft Office Suite is a must.

🏝️ Benefits

• Remote working opportunities.

• Flexible time off policy.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement program.

• Retirement plans available.

• Potential for bonuses.

• An inclusive company culture.

• Reasonable accommodations and accessible application process.