Senior Regulatory Medical Writer & Team Lead

MMS; San Diego (CA); On-site; USD 110,000 - 120,000; Full time

Job summary

MMS is a global CRO focused on data-driven regulatory writing for pharmaceutical clients. The Medical Writer will evaluate literature, draft protocols, study reports, consent forms, and safety summaries, ensuring scientific rigor and regulatory compliance.

With 3+ years in regulatory writing, you will mentor junior writers, coordinate with clients, and manage timelines under tight schedules. Strong MS Word and presentation skills are essential in a collaborative, fast-paced environment in San

Qualifications

• At least 3 years of experience in the pharmaceutical industry.
• 3-5 years of regulatory writing and clinical medical writing experience.
• Bachelor/Master/PhD in scientific, medical, or clinical discipline.

Responsibilities

• Under minimal supervision, evaluate, analyze, and interpret medical literature to select primary materials for study design, statistical significance, scientific rigor, and absence of bias.
• Write and edit clinical development documents including protocols, investigator's brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2.7.x documents, presentations, and journal publications.
• Complete writing assignments in a timely manner and maintain timelines and workflows.
• Mentor medical writers and other project team members involved in the writing process.

Skills

Regulatory writing

Medical writing

Project leadership

Interpersonal communication

MS Word

MS Excel

PowerPoint

Regulatory submissions

Education

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

Tools

MS Word

MS Excel

PowerPoint

Job description

MMS is a global CRO focused on data-driven regulatory writing for pharmaceutical clients. The Medical Writer will evaluate literature, draft protocols, study reports, consent forms, and safety summaries, ensuring scientific rigor and regulatory compliance.

With 3+ years in regulatory writing, you will mentor junior writers, coordinate with clients, and manage timelines under tight schedules. Strong MS Word and presentation skills are essential in a collaborative, fast-paced environment in San