Medical Writer

Senior Medical Writing Consultant (Remote)

We’re seeking an experienced Medical Writer to support a growing biotechnology organization on a contract basis. This individual will play a key role in the development of 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)
• 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

Qualifications

• 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
• 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
• Prior experience supporting small to mid-sized biotech organizations preferred

Location

• Fully remote within the United States

This is an excellent opportunity for a seasoned medical writer to contribute to innovative drug development programs while working with a collaborative and fast-paced biotech team.