Senior Regulatory & Medical Writing Leader

MMS; Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

MMS, a data-focused clinical research organization, invites a senior Medical Writer to guide regulatory documentation and regulatory submissions. You will mentor staff, lead complex documents, and ensure quality and compliance across clinical trial programs.

Join a Great Place to Work-certified team with a collaborative culture, driving innovative solutions for pharmaceutical, biotech, and medical device clients worldwide.

Qualifications

• Minimum 6 years’ experience in Regulatory and Medical Writing or similar field.
• Proven experience mentoring Medical Writing professionals.
• Strong understanding of ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Proficient with MS Office; experience with clinical trial data.

Responsibilities

• Oversee regulatory and medical writing projects from start to finish.
• Mentor and develop Medical Writing professionals; act as SME.
• Lead client meetings and manage CRMs; mitigate project risk.
• Implement strategic policies for document standards and timelines.
• Collaborate with cross-functional teams to meet deliverables.

Skills

Regulatory writing

Medical writing styles

QC tools

AI-assisted writing

Project leadership

Client meetings

Risk management

Issue resolution

Education

Bachelor/advanced degree in scientific field

Tools

MW tools

Job description

MMS, a data-focused clinical research organization, invites a senior Medical Writer to guide regulatory documentation and regulatory submissions. You will mentor staff, lead complex documents, and ensure quality and compliance across clinical trial programs.

Join a Great Place to Work-certified team with a collaborative culture, driving innovative solutions for pharmaceutical, biotech, and medical device clients worldwide.