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.