Senior Medical Writer - Regulatory Documentation

MMS; Miami (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

MMS, a data-focused CRO, is seeking a Medical Writer to critically evaluate literature and prepare regulatory and clinical development documents, including protocols, investigator’s brochures, and study reports. The role requires leadership in writing projects, mentoring colleagues, and coordinating with clients to meet tight deadlines.

Ideal candidates will have 3+ years in pharma, strong regulatory writing experience, and advanced MS Office skills.

Qualifications

• Minimum 3 years in the pharmaceutical industry.
• 3-5 years of regulatory writing and clinical medical writing experience.
• Bachelor's, Master's, or Ph.D. in scientific/medical/clinical discipline.
• Substantial protocol experience as lead author.
• Experience leading and managing teams with aggressive timelines.
• Experience in regulatory submissions to authorities is a plus.
• Understanding of clinical data and regulatory writing standards.
• Exceptional writing skills and strong organizational ability.
• Expertise with MS Word, Excel and PowerPoint and related tools.
• Project lead or project team management experience.
• Knowledge of GCP and ICH guidelines is a plus.
• Orphan designation experience is a plus.

Responsibilities

• Critically evaluate literature to select primary materials for study design and bias assessment.
• Write and edit clinical development documents (protocols, brochures, study reports, consent forms, summaries).
• Produce materials for regulatory submissions and publications.
• Maintain timelines and manage writing workflow.
• Provide high-quality client service and communications.
• Adhere to client templates and style guides with accuracy.
• Coordinate with project team and clients to ensure project alignment.
• Mentor junior writers and other team members on writing processes.
• Take ownership of assignments and consult others as needed.

Skills

Regulatory writing

Medical writing

Project leadership

Mentoring

Client communication

MS Word

MS Excel

PowerPoint

Regulatory templates

Team coordination

Education

Bachelor's degree

Master's degree

PhD

Tools

MS Word

MS Excel

PowerPoint

Job description

MMS, a data-focused CRO, is seeking a Medical Writer to critically evaluate literature and prepare regulatory and clinical development documents, including protocols, investigator’s brochures, and study reports. The role requires leadership in writing projects, mentoring colleagues, and coordinating with clients to meet tight deadlines.

Ideal candidates will have 3+ years in pharma, strong regulatory writing experience, and advanced MS Office skills.