Regulatory & Medical Writing Lead: Strategy & Mentorship

MMS Holdings Inc; Raleigh (NC); Remote; USD 110,000 - 170,000; Full time

Job summary

MMS Holdings Inc. is a data-focused CRO supporting pharma, biotech, and medical device clients with regulatory submissions and trial data solutions. We seek an experienced Regulatory Medical Writer to lead writing efforts, mentor peers, and ensure quality in a collaborative, ISO-minded environment.

The role emphasizes independent project leadership, client communication, and adherence to 21 CFR Part 11 and GCP standards, shaping strategic deliverables across programs.

Qualifications

• Bachelor-level or higher science/clinical degree with related experience.
• Minimum of 6 years in Regulatory/Medical Writing or similar field.
• Proven mentorship and development of Medical Writing staff.
• Able to anticipate and resolve client demands effectively.
• Demonstrates managerial experience and problem-solving skills.

Responsibilities

• Mentor Medical Writing staff and lead key projects.
• Manage client meetings and CRMs to ensure alignment.
• Independently manage projects from start to finish.
• Identify and mitigate project risks and client gaps.
• Address client feedback with appropriate follow-up.

Skills

Regulatory writing expertise

Mentoring/leadership

Regulatory updates awareness

AI-assisted writing experience

Client meetings & CRM

Risk management & project leadership

Problem solving & organization

Communication skills

ISO 9001 familiarity

ISO 27001 familiarity

Education

Master's or PhD preferred

Tools

MS Office

MW tools

CRM software

Job description

MMS Holdings Inc. is a data-focused CRO supporting pharma, biotech, and medical device clients with regulatory submissions and trial data solutions. We seek an experienced Regulatory Medical Writer to lead writing efforts, mentor peers, and ensure quality in a collaborative, ISO-minded environment.

The role emphasizes independent project leadership, client communication, and adherence to 21 CFR Part 11 and GCP standards, shaping strategic deliverables across programs.