Senior Medical Writer (Pharmaceuticals)

TL;DR

Senior Medical Writer (Pharmaceuticals): Writing and editing clinical development documents and regulatory submissions with an accent on scientific rigor and regulatory compliance. Focus on authoring clinical study protocols, managing project timelines, and mentoring junior medical writers.

Location: Remote (Must be based in the United States of America)

Company

Innovative, data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data.

What you will do

• Critically evaluate medical literature to ensure study design rigor and absence of bias.
• Author and edit clinical protocols, investigator’s brochures, clinical study reports, and efficacy summaries.
• Manage timelines and workflows for writing assignments independently.
• Coordinate project facets directly with clients to ensure deliverables meet standards.
• Mentor medical writers and other project team members involved in the writing process.

Requirements

• 3-5 years of industry regulatory and clinical medical writing experience.
• 3+ years of experience in the pharmaceutical industry.
• Degree in a scientific, medical, or clinical discipline (Bachelors, Masters, or Ph.D.).
• Substantial experience as a lead author for clinical study protocols.
• Expert proficiency in MS Word, Excel, and PowerPoint.
• Experience leading and managing project teams.

Nice to have

• Experience in regulatory submissions presented to regulatory authorities.
• Strong understanding of federal regulations, Good Clinical Practices (GCP), and ICH guidelines.
• Experience with orphan drug designations and PSP/PIPs.

Culture & Benefits

• Collaborative and teamwork-oriented environment.
• Access to a global and diverse talent pool.
• Emphasis on continual training to strengthen core professional skills.
• Support for high-quality service and technology solutions in life-changing therapies.