Senior Medical Writing & Regulatory Manager

MMS Holdings Inc; Manchester; Remote; GBP 55,000 - 85,000; Full time

Job summary

MMS Holdings Inc. is seeking an experienced Medical Writer to join our regulatory documentation team. You will ensure compliance with CFR Part 11, FDA, GCP; mentor junior staff; lead complex writing projects from start to finish.

The role requires a strong background in regulatory and medical writing, familiarity with ISO 9001/27001, and ability to manage client expectations and deliver high-quality submissions across clinical trial programs.

Qualifications

• Degree in scientific/clinical field; Master/PhD preferred.
• 6+ years in Regulatory and Medical Writing or similar field.
• Proven experience mentoring Medical Writing professionals.
• Ability to anticipate and resolve client demands.
• Demonstrates managerial skill and experience.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trials/pharma development.
• Excellent communication and problem-solving skills.
• Familiarity with ISO 9001/27001; 21 CFR Part 11, FDA and GCP.

Responsibilities

• Independently manages a project from start to finish.
• Mentors and develops Medical Writing professionals; supports Associate-level staff.
• Leads client meetings and manages expectations; handles feedback and resolution.
• Identifies and mitigates project risks; aligns with regulatory requirements.
• Ensures adherence to writing standards and regulatory guidelines.

Skills

Regulatory writing

Medical writing mentoring

Regulatory updates

AI-assisted authoring

Project leadership

Client meetings & CRMs

Team supervision

Problem solving

Documentation standards

Education

Master's or PhD preferred

Bachelor's degree in scientific/clinical field

Tools

MS Office

MW tools

CRM tools

Job description

MMS Holdings Inc. is seeking an experienced Medical Writer to join our regulatory documentation team. You will ensure compliance with CFR Part 11, FDA, GCP; mentor junior staff; lead complex writing projects from start to finish.

The role requires a strong background in regulatory and medical writing, familiarity with ISO 9001/27001, and ability to manage client expectations and deliver high-quality submissions across clinical trial programs.