Senior Medical Writer (Pharma)

TL;DR

Senior Medical Writer (Pharma): Developing and editing complex clinical development documents for pharmaceutical and biotech trials with an accent on regulatory compliance and scientific rigor. Focus on authoring clinical study protocols, investigator brochures, and regulatory submission reports while managing project timelines and mentoring team members.

Location: Must be based in the United States

Company

hirify.global is an innovative, data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with scientific expertise in complex trial data and regulatory submissions.

What you will do

• Critically analyze medical literature to ensure study design and scientific rigor.
• Write and edit clinical protocols, investigator brochures, and clinical study reports.
• Coordinate project facets through direct and independent client interaction.
• Manage production of interpretive guides and maintain strict project timelines.
• Mentor junior medical writers and project team members involved in the writing process.
• Ensure all documentation adheres to client templates and regulatory style guides.

Requirements

• Must be based in the United States
• Minimum 3-5 years of industry regulatory and clinical medical writing experience.
• Substantial experience as a lead author for clinical study protocols.
• Bachelor’s, Master’s, or Ph.D. in a scientific, medical, or clinical discipline.
• Expert proficiency in MS Word, Excel, and PowerPoint.
• Proven experience leading project teams and managing aggressive timelines.

Nice to have

• Experience with regulatory submissions (clinical study reports) for authorities.
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines.
• Experience with orphan drug designations and PSP/PIPs.

Culture & Benefits

• Global and diverse talent pool fostering collaboration and teamwork.
• Commitment to continual training and strengthening core professional skills.
• Focus on delivering life-changing therapies to improve global health outcomes.