Senior Medical Writer Full-Time Remote Opportunity
Location: Fully Remote (U.S.)
Industry: Pharmaceutical / Biotechnology
Employment Type: Full-Time
Salary Range: $142,100 $195,360 annually
Experience Level: Mid-Senior
Job Overview
We are seeking an experienced Senior Medical Writer to support clinical development and regulatory documentation activities within a leading biotechnology environment. This fully remote opportunity is ideal for a highly skilled clinical science writer with extensive experience authoring Clinical Study Reports (CSRs), protocols, and regulatory submission documents across Phase I III studies.
The ideal candidate is a hands-on writer who spends the majority of their time authoring and developing scientific and regulatory documents rather than primarily editing or managing teams. Strong expertise in clinical development, regulatory writing standards, and cross-functional collaboration is essential.
Key Responsibilities
Author and edit clinical study documents including protocols, protocol amendments, informed consent forms, and Clinical Study Reports (CSRs)
Prepare regulatory submission documents including briefing books and eCTD summaries/modules
Draft aggregate safety and efficacy documents including DSURs, PBRERs, and Investigator Brochures
Manage document timelines, review cycles, and comment adjudication processes
Lead and facilitate document-related meetings with cross-functional study teams
Collaborate with clinical, biostatistics, regulatory, pharmacovigilance, and data management teams
Interpret and present complex clinical data in clear scientific narratives, tables, and graphics
Ensure all documentation complies with regulatory guidelines, industry standards, and internal style guides
Support process improvements, templates, and standard operating procedures within Medical Writing
Requirements
Bachelor's degree or higher in a scientific discipline required
7 10+ years of medical writing experience within biotech, pharmaceutical, or CRO environments
Extensive experience authoring Clinical Study Reports (CSRs) and protocol amendments required
Experience with INDs, NDAs, BLAs, DSURs, PBRERs, and regulatory briefing books strongly preferred
Strong understanding of clinical development processes and regulatory requirements
Experience with eCTD submissions and Modules 2 5 preferred
Ability to interpret complex clinical and statistical data
Excellent scientific writing, communication, and organizational skills
Proficiency with Microsoft Office Suite, Adobe Acrobat, Veeva, SharePoint, or similar document management systems
Ability to manage multiple projects and work independently in a remote environment
Ideal Candidate Profile
Highly experienced clinical medical writer with strong Phase I III study expertise
Focused primarily on authoring scientific and regulatory content rather than editing or project management
Demonstrated excellence in CSR development and clinical science documentation
Biotech or pharmaceutical industry background strongly preferred
CRO experience considered
Strong attention to detail with the ability to meet strict timelines and regulatory standards