Senior Medical Writer

TL;DR

Senior Medical Writer (Medical/Regulatory): Authoring and editing high-quality clinical and regulatory documentation for biotech and pharmaceutical clients with an accent on compliance with FDA and ICH standards. Focus on managing complex submission-level documents, mentoring junior staff, and ensuring deliverables meet strict timelines and quality requirements.

Location: Must be based in the United States. While remote work is supported, hybrid collaboration is encouraged for those near company offices.

Company

hirify.global provides expert consulting and operational support across the complete product lifecycle for biotech, medical device, and pharmaceutical organizations.

What you will do

• Author and edit clinical, safety, and regulatory documents including protocols, study reports, and submission-level dossiers.
• Manage client expectations, lead project meetings, and oversee deliverable timelines.
• Collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs.
• Perform QC reviews and peer reviews of documents to ensure accuracy and consistency.
• Mentor and supervise less experienced medical writers.
• Maintain audit trails and ensure adherence to regulatory guidelines and client-specific templates.

Requirements

• Minimum 5 years of experience in clinical or regulatory writing for drugs, biologics, or medical devices.
• Advanced knowledge of clinical research principles and regulatory submission processes.
• Expert proficiency in MS Word, including tables, graphs, and figures.
• English language proficiency with familiarity in AMA style.
• Strong project management and communication skills.
• Bachelor’s degree or higher in a medical or scientific discipline.

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Supportive environment for professional growth and innovation.
• Collaborative team culture with a focus on work-life balance.
• Opportunities to work on high-profile drug and device programs.