Global Lead, Regulatory & Medical Writing

MMS Holdings Inc; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc, a data-focused clinical research organization, seeks a medical writing professional to ensure regulatory deliverables meet rigorous standards. The role sits within a supportive, innovative team and benefits from MMS's Great Place to Work certification and strong retention.

Based across a global footprint, MMS supports pharma, biotech and medical device projects, mentoring colleagues, leading initiatives, and managing client meetings while advancing regulatory compliance and

Qualifications

• 6+ years of Regulatory and Medical Writing experience.

Responsibilities

• Supervise and mentor medical writing team; assign tasks.
• Lead projects from initiation to completion; manage timelines.
• Identify and mitigate project risks; address client gaps.
• Manage client meetings and CRM records.
• Implement regulatory writing standards across deliverables.
• Stay updated on regulatory changes and advise the team.

Skills

Regulatory writing

Medical writing

Mentoring

Project leadership

Client meetings

Risk management

Regulatory updates

AI-assisted authoring tools

QC processes

Leadership initiative

Education

Bachelor’s degree in scientific/medical discipline

Master’s or PhD preferred

Tools

MS Office

MW tools

AI-assisted authoring tools

Job description

MMS Holdings Inc, a data-focused clinical research organization, seeks a medical writing professional to ensure regulatory deliverables meet rigorous standards. The role sits within a supportive, innovative team and benefits from MMS's Great Place to Work certification and strong retention.

Based across a global footprint, MMS supports pharma, biotech and medical device projects, mentoring colleagues, leading initiatives, and managing client meetings while advancing regulatory compliance and