Senior Regulatory & Medical Writing Leader

MMS Holdings Inc; Chicago (IL); Remote; USD 110,000 - 150,000; Full time

Job summary

MMS Holdings Inc in Chicago, IL is seeking an experienced Regulatory and Medical Writing professional to lead document development for regulatory submissions. You will mentor teams, manage client expectations, and ensure adherence to quality and compliance standards.

The role requires strong writing expertise, deep knowledge of FDA regulations, and the ability to coordinate cross-functional teams from planning through submission.

Qualifications

• College graduate in scientific, medical, clinical discipline or related field, Master's or PhD preferred.
• Minimum of 6 years’ experience in Regulatory and Medical Writing or similar field required.
• Proven direct experience managing, mentoring, and developing Medical Writing professionals.
• Demonstrates managerial skill and experience.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Hands-on experience with clinical trial and pharmaceutical development preferred.

Responsibilities

• Independently manages a project from start to finish.
• Provides leadership to the team, assigns tasks, and reviews work regularly.
• Mentors managers and identifies leadership roles for reports.
• Manages client meetings and CRMs and addresses client feedback.

Skills

Regulatory writing

Medical writing

Mentoring

Regulatory updates

QA & MW tools

AI-assisted authoring

Project risk management

Client meetings & CRMs

Deliverable ownership

Leadership & supervision

Regulatory strategy

ISO 9001 / ISO 27001 familiarity

FDA / CFR / GCP knowledge

Job description

MMS Holdings Inc in Chicago, IL is seeking an experienced Regulatory and Medical Writing professional to lead document development for regulatory submissions. You will mentor teams, manage client expectations, and ensure adherence to quality and compliance standards.

The role requires strong writing expertise, deep knowledge of FDA regulations, and the ability to coordinate cross-functional teams from planning through submission.