Principal Medical Writer

Location: Durham, North Carolina, United States of America

Salary: $84,400–$211,100 annual base pay

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead the development of Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submission documents.
• Act as lead writer for key summary documents across multiple compounds or programs.
• Guide cross-functional teams on document content, scientific messaging, and regulatory positioning.
• Plan medical writing projects, coordinate resources, manage timelines, and deliver against submission milestones.
• Collaborate with Clinical, Regulatory Affairs, Biostatistics, Safety, and other stakeholders to interpret and present clinical data.
• Mentor medical writers, review deliverables, and lead improvements to SOPs, templates, and writing processes.

Requirements

• Bachelor’s degree in a scientific, clinical, regulatory, or related field; an advanced degree such as MSc, PhD, PharmD, or MD is preferred.
• At least 7 years of medical writing experience in the biopharmaceutical, biotechnology, or CRO industry, or equivalent clinical or preclinical development experience.
• Strong knowledge of global regulatory requirements and ICH, FDA, and EMA guidelines across clinical development phases.
• Understanding of clinical research processes, including study design, data analysis, and regulatory submissions.
• Experience leading complex document development and providing strategic input to cross-functional teams.
• Strong communication, organization, project management, attention to detail, and Microsoft Word skills.

Culture & Benefits

• Work in a cross-functional, team-oriented environment while operating independently when needed.
• Contribute to the development of innovative medical treatments and improved patient outcomes.
• Potential incentive plans, bonuses, and other compensation may be available depending on the position.
• Health, welfare, and other benefits may be provided.