Senior Medical Writer - Regulatory Submissions (Remote UK)

MMS; Greater London; Remote; GBP 60,000 - 90,000; Full time

Job summary

MMS is a data-focused clinical research organization with a global footprint and a strong culture of excellence. We are seeking a Medical Writer to critically evaluate medical literature, author regulatory documents, and guide projects through tight timelines.

The role requires extensive regulatory writing experience, leadership, and the ability to manage teams while delivering high-quality clinical study reports and related materials. Remote UK-based position with collaboration across teams.

Qualifications

• Bachelor's, Masters or PhD in scientific/medical field with at least 6 years regulatory writing experience.
• Substantial clinical study protocol experience as lead author.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
• Experience in regulatory submissions (clinical study reports) to regulatory authorities is a plus.
• Exceptional writing skills and excellent organizational abilities; multitasking.
• Expert in MS Word, Excel, PowerPoint and related word processing tools.
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
• Experience with orphan drug designations and PSP/PIPs a plus (not required).

Responsibilities

• Critically evaluate and interpret medical literature to select primary resources for study design.
• Write and edit clinical development documents including protocols, brochures, reports, consent forms.
• Meet deadlines and manage writing work plans.
• Maintain timelines and workflow of writing assignments.
• Interact with clients to coordinate projects and maintain communication.
• Mentor medical writers and project team members.
• Develop interpretive guides and ensure regulatory style compliance.

Skills

Regulatory writing

Leadership

Project management

MS Word

MS Excel

PowerPoint

Exceptional writing skills

Education

Bachelor’s degree in scientific/medical field

Master’s degree or PhD in relevant field

Tools

Regulatory templates & style guides

Job description

MMS is a data-focused clinical research organization with a global footprint and a strong culture of excellence. We are seeking a Medical Writer to critically evaluate medical literature, author regulatory documents, and guide projects through tight timelines.

The role requires extensive regulatory writing experience, leadership, and the ability to manage teams while delivering high-quality clinical study reports and related materials. Remote UK-based position with collaboration across teams.