This is a fully remote position, open to applicants in United States, +6 more locations.

📋 Description

• Take the initiative to plan and create a variety of regulatory documents and medical communications that support every phase of product development.

• Systematically organize, analyze, interpret, and present scientific and statistical data in compliance with ICH and other regulatory standards, as well as company documentation protocols.

• Operate under the guidance of Medical Writing management.

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

⛳️ Requirements

• A Bachelor’s degree is required; a degree in a science-related field is preferred.

• At least 7 years of medical writing experience in a contract research organization or within the pharmaceutical/biotechnology research environment. Other relevant professional and/or educational experiences may be considered to meet this minimum requirement, evaluated on an individual basis.

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

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

• Excellent interpersonal and communication abilities.

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