Regulatory Medical Writer Lead

MMS; St. Louis (MO); On-site; USD 90,000 - 140,000; Full time

Job summary

MMS is seeking an experienced Medical Writer to support regulatory submissions and clinical development documents. You will evaluate literature, author protocols, study reports, and safety analyses, ensuring scientific rigor and regulatory compliance.

The role requires effective communication with clients and cross-functional teams to deliver high-quality documents on aggressive timelines. The ideal candidate possesses at least 3 years in pharma regulatory writing, advanced editing skills, and a

Qualifications

• 3+ years in pharmaceutical industry
• 3–5 years in regulatory writing and clinical medical writing
• Bachelor’s/Master’s/PhD in scientific/medical/clinical discipline
• Lead author experience on substantial clinical study protocols
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills
• Excellent organizational skills and ability to multi-task
• Experience as a project lead or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Orphan drug designations and PSP/PIPs experience a plus

Responsibilities

• Critically evaluate, analyze, and interpret medical literature for study design, significance, and rigor
• Write and edit clinical development documents (protocols, investigator’s brochures, study reports, ICFs, safety/efficacy summaries, Module 2.7.x, and publications)
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing projects
• Practice good internal and external customer service
• Proficient with client templates and style guides
• Interacts directly with clients to coordinate all project facets
• Contribute to or manage production of interpretive guides
• Take ownership of assignments and consult team members as needed
• Mentor medical writers and project team members

Skills

Medical writing

Regulatory writing

Leadership

Project management

Communication

Education

Bachelor's/Master's/PhD in scientific/medical/clinical discipline

Tools

MS Word

MS Excel

PowerPoint

Job description

MMS is seeking an experienced Medical Writer to support regulatory submissions and clinical development documents. You will evaluate literature, author protocols, study reports, and safety analyses, ensuring scientific rigor and regulatory compliance.

The role requires effective communication with clients and cross-functional teams to deliver high-quality documents on aggressive timelines. The ideal candidate possesses at least 3 years in pharma regulatory writing, advanced editing skills, and a