Principal Medical Writer

This is a fully remote position, open to applicants in United States, +4 more locations.

📋 Description

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

• Organize, analyze, interpret, and effectively present scientific and statistical information.

• Ensure that all documents adhere to ICH guidelines, other regulatory requirements, and company document standards.

• Operate under the guidance of Medical Writing management.

• Collaborate with both internal and external teams involved in document production across various functions.

⛳️ Requirements

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

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

• Additional professional or educational experiences may be considered in lieu of the minimum experience requirement on a case-by-case basis.

• In-depth knowledge of ICH and associated regulatory guidelines is essential.

• Exceptional written English skills and a strong attention to detail are required.

• Strong interpersonal and communication abilities are necessary.

• Proficiency in Microsoft Office Suite, particularly advanced skills in Microsoft Word, is mandatory.

🏝️ Benefits

• Opportunity for remote work.

• Flexible time off policies.

• Paid holidays provided.

• Medical insurance coverage.

• Tuition reimbursement options available.

• Retirement plans offered.