Senior Medical Writer — Regulatory Submissions Lead

MMS; Louisville (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

MMS is seeking a Medical Writer to support regulatory documentation for pharma, biotech and medical device projects. The role focuses on critical evaluation of literature, writing clinical protocols, study reports and safety summaries, and coordinating with sponsors to ensure high-quality, timely deliverables.

Ideal candidates have 3–5 years of regulatory writing and clinical medical writing experience, with strong MS Word skills, excellent writing ability, and a track record of leading project

Qualifications

• At least 3 years of experience in the pharmaceutical industry.
• 3–5 years of industry regulatory writing and clinical medical writing experience.
• Candidates should hold a Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
• Substantial experience with lead authoring of clinical study protocols.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
• Experience in regulatory submissions (clinical study reports) is a plus.
• Understanding of clinical data and standards.
• Exceptional writing, organizational, and multitasking skills.
• Expert in MS Word, Excel, PowerPoint and related tools.
• Experience as project lead or managing a project team is preferred.
• Knowledge of federal regulations, Good Clinical Practices, ICH guidelines a plus.
• Orphan drug designations and PSP/PIPs experience a plus (not required).

Responsibilities

• Evaluate and interpret medical literature to select primary resources for study design and regulatory documents.
• Write and edit clinical development documents including protocols, investigator's brochures, study reports, consent forms, safety and efficacy summaries and Module 2.x documents.
• Maintain timelines and workflow for writing assignments.
• Mentor medical writers and project team members involved in the writing process.
• Interact with clients to coordinate projects and ensure quality results.

Skills

Regulatory writing

Clinical writing

Project leadership

MS Word

MS Excel

Communication skills

Attention to detail

Team mentoring

Education

Bachelor's degree in life sciences

Master's degree or PhD preferred

Tools

MS Project

EndNote

Adobe Acrobat

Regulatory submission tools

Job description

MMS is seeking a Medical Writer to support regulatory documentation for pharma, biotech and medical device projects. The role focuses on critical evaluation of literature, writing clinical protocols, study reports and safety summaries, and coordinating with sponsors to ensure high-quality, timely deliverables.

Ideal candidates have 3–5 years of regulatory writing and clinical medical writing experience, with strong MS Word skills, excellent writing ability, and a track record of leading project