Senior Medical Writing Consultant - Remote

About This Role

This contract role is for an experienced Medical Writer to support a growing biotechnology organization. The individual will be key in developing clinical and regulatory documents across multiple programs, collaborating with cross-functional teams to ensure high-quality, submission-ready content.

Responsibilities

• Develop, edit, and maintain a variety of clinical and regulatory documents, including Clinical Study Protocols, Protocol Amendments, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Regulatory submissions and responses, Development Safety Update Reports (DSURs, and additional scientific, clinical, and regulatory documents as needed
• Gather and synthesize information from cross-functional stakeholders and subject matter experts
• Partner closely with clinical, regulatory, and medical teams to ensure document accuracy, consistency, and compliance
• Manage multiple writing projects and timelines in a remote work environment
• Participate in team meetings and support other initiatives as needed

Requirements

• Bachelor's degree or higher in a scientific, medical, or related discipline
• 10+ years of medical writing experience within the pharmaceutical or biotechnology industry
• Strong experience authoring complex clinical study protocols and amendments, Phase I and Phase II Clinical Study Reports, Investigator Brochures, DSURs, and regulatory submissions and health authority responses
• Experience serving as a lead writer or submissions lead for regulatory deliverables
• Proficiency with Microsoft Word and document management systems such as Veeva Vault
• Excellent written, verbal, and interpersonal communication skills
• Strong project management skills with the ability to work independently and collaborate across teams

Nice to have:

• Prior experience supporting small to mid-sized biotech organizations