Senior Medical Writer (Regulatory) – Remote MMS The Difference is in the Data

Workinvirtual; United Kingdom; Remote; GBP 45,000 - 70,000; Full time

Job summary

A leading global Contract Research Organization is seeking a Regulatory Medical Writer. This fully remote role offers the chance to develop key regulatory documents and mentor junior writers, all while collaborating in a science-driven environment. Candidates should possess substantial experience in regulatory writing and a strong understanding of industry guidelines.

Benefits

Fully remote work

Opportunity to lead high-impact projects

Collaborative work environment

Qualifications

• Minimum 6+ years in regulatory medical writing.
• Substantial expertise in clinical study protocols and reports.
• Experience with orphan drug designations preferred.

Responsibilities

• Research and interpret medical literature for regulatory documents.
• Author and edit clinical protocols, study reports, and submissions.
• Lead cross-functional teams to prepare regulatory submissions.

Skills

Scientific writing

Editing

Project leadership

Team collaboration

Knowledge of ICH guidelines

Knowledge of GCP

Knowledge of FDA regulations

Knowledge of EMA regulations

Education

Bachelor’s degree in life sciences, medicine, or related field

Master’s or PhD preferred

Tools

MS Word

Excel

PowerPoint

Document management tools

Job description

MMS Holdings is an award-winning, data-focused Contract Research Organization (CRO) that partners with pharmaceutical, biotech, and medical device industries to deliver scientifically robust regulatory submissions and clinical trial solutions. With a global presence and a 97% customer satisfaction rate, MMS combines deep industry expertise with advanced technology to meet stringent regulatory requirements. Recognized as a top CRO for three consecutive years, MMS is dedicated to innovation and excellence in drug development.

Key Responsibilities:

• Research, analyze, and interpret medical literature to ensure scientific accuracy and regulatory compliance in clinical documents.

• Author and edit high-quality regulatory documents, including clinical protocols, study reports, investigator brochures, informed consent forms, and Module 2 (2.5, 2.7.1-2.7.4) submissions.

• Manage multiple writing assignments, adhering to deadlines while maintaining consistency with client templates and style guides.

• Serve as a primary point of contact for clients, coordinating project requirements and ensuring clear communication.

• Mentor junior writers and contribute to process improvements in document development.

• Lead cross-functional teams in preparing complex regulatory submissions under tight timelines.

Requirements:

• Education:Bachelor’s degree (Master’s or PhD preferred) in life sciences, medicine, or a related field.

• Experience:Minimum 6+ years in regulatory medical writing, with substantial expertise in clinical study protocols and reports.

• Skills:

  • Exceptional scientific writing and editing abilities.

  • Proficiency in MS Word, Excel, PowerPoint, and document management tools.

  • Strong project leadership and team collaboration skills.

  • In-depth knowledge of ICH guidelines, GCP, and FDA/EMA regulations.

• Preferred:Experience with orphan drug designations, PSP/PIPs, or regulatory submissions (e.g., CSR, IB).

Why Apply?

• Fully remote role with a globally recognized CRO.

• Opportunity to lead high-impact regulatory documents and mentor teams.

• Collaborative, science-driven work environment.

Apply Now:Submit Your Application Here