Senior Medical Writer — Regulatory Submissions Lead

MMS; New York (NY); On-site; USD 110,000 - 120,000; Full time

Job summary

MMS, a data-focused CRO, seeks an experienced Medical Writer in New York to critically evaluate literature, select materials for study design, and prepare regulatory documents. You will write and edit protocols, investigators’ brochures, study reports, consent forms, safety summaries, and modules to regulatory standards.

You will mentor team members, coordinate with clients to ensure timely delivery, and maintain high quality across multiple documents while adhering to strict timelines.

Qualifications

• 3+ years of experience in pharmaceutical industry with regulatory writing focus.
• 3–5 years of industry regulatory writing and clinical medical writing experience.
• Bachelor’s, Master’s, or Ph.D. in scientific/medical discipline preferred.
• Substantial clinical study protocol experience as lead author required.
• Experience leading and managing teams with aggressive timelines for regulatory documents.
• Experience in regulatory submissions (clinical study reports) a plus.
• Understanding of clinical data and strong writing skills.
• Excellent organizational skills and multitasking abilities.
• Expert in MS Word, Excel, PowerPoint, and related tools.
• Project leadership experience or managing a project team.
• Knowledge of federal regulations, GCP, and ICH guidelines is a plus.
• Orphan drug designations and PSP/PIPs experience a plus

Responsibilities

• Critically evaluate, analyze, and interpret literature to select primary materials for study design, statistical significance, and bias-free reporting.
• Write and edit regulatory documents including protocols, investigator’s brochures, study reports, consent forms, safety summaries, and module documents.
• Maintain timelines and ensure timely completion of writing assignments.
• Internally and externally communicate with clients to coordinate projects and maintain high service levels.
• Mentor junior writers and project team members involved in writing processes.

Skills

Regulatory writing

Clinical medical writing

Team leadership

Editing & proofreading

Client communication

MS Word proficiency

MS Excel

PowerPoint

Education

Bachelor's/Master's/PhD in science/medical field

Tools

MS Word

MS Excel

PowerPoint

Job description

MMS, a data-focused CRO, seeks an experienced Medical Writer in New York to critically evaluate literature, select materials for study design, and prepare regulatory documents. You will write and edit protocols, investigators’ brochures, study reports, consent forms, safety summaries, and modules to regulatory standards.

You will mentor team members, coordinate with clients to ensure timely delivery, and maintain high quality across multiple documents while adhering to strict timelines.