Senior Medical Writer — Regulatory Submissions & Lead Author

MMS; Baltimore (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

MMS is a data-focused CRO supporting pharma, biotech, and medical device industries with regulatory-driven trial data expertise. We seek a Medical Writer to evaluate literature, author regulatory documents, and ensure scientific rigor.

The role requires 3+ years in pharma writing, strong MS Word/Excel/PowerPoint skills, and ability to manage timelines while mentoring junior writers. Join a global, collaborative team delivering high-quality literature and docs.

Qualifications

• At least 3 years of experience in the pharmaceutical industry.
• 3–5 years of regulatory writing and clinical medical writing experience.
• Ideal candidate holds a Bachelor’s, Master’s, or Ph.D. in scientific/medical discipline.
• Substantial clinical study protocol experience as lead author.
• Experience leading and managing teams with aggressive timelines.
• Exposure to regulatory submissions (clinical study reports) is a plus.
• Strong understanding of clinical data.
• Exceptional writing and organizational skills.

Responsibilities

• Critically evaluate, analyze, and interpret medical literature to select primary materials for study design, statistical significance, and bias avoidance.
• Write and edit clinical development documents (protocols, investigator brochures, study reports, consent forms, safety/efficacy summaries, modules).
• Complete writing assignments in a timely manner and maintain workflow timelines.
• Mentor medical writers and project teams involved in writing processes.
• Interact with clients to coordinate all project facets and communicate effectively.

Skills

Regulatory writing

Medical writing

Project management

Mentoring

Client communication

Education

Bachelor's degree

Master's degree

PhD

Tools

MS Word

MS Excel

PowerPoint

Job description

MMS is a data-focused CRO supporting pharma, biotech, and medical device industries with regulatory-driven trial data expertise. We seek a Medical Writer to evaluate literature, author regulatory documents, and ensure scientific rigor.

The role requires 3+ years in pharma writing, strong MS Word/Excel/PowerPoint skills, and ability to manage timelines while mentoring junior writers. Join a global, collaborative team delivering high-quality literature and docs.