Senior Regulatory & Medical Writing Lead

MMS Holdings Inc; Phoenix (AZ); Remote; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc is a leading data-focused clinical research organization seeking a Senior Medical Writer in Phoenix, AZ. You will contribute to regulatory submissions and medical writing across trial data, ensuring compliance with guidelines and high-quality deliverables.

You will mentor junior writers, manage projects from start to finish, and collaborate with cross-functional teams to meet deadlines and regulatory expectations.

Qualifications

• 6+ years of Regulatory and Medical Writing experience.
• Experience mentoring Medical Writing professionals.
• Familiarity with 21 CFR Part 11, FDA, and GCP.

Responsibilities

• Prepare and manage regulatory submission documents.
• Provide regulatory writing strategies and guidance.
• Lead small writing teams and oversee project timelines.
• Collaborate with clients and cross-functional teams.
• Address client feedback and ensure deliverables meet quality standards.

Skills

Regulatory writing

Medical writing

Project leadership

Mentoring

Client management

CRM proficiency

AI-assisted authoring

Education

Bachelor's degree in scientific/medical discipline

Master's or PhD preferred

Tools

MS Office

MW tools

Job description

MMS Holdings Inc is a leading data-focused clinical research organization seeking a Senior Medical Writer in Phoenix, AZ. You will contribute to regulatory submissions and medical writing across trial data, ensuring compliance with guidelines and high-quality deliverables.

You will mentor junior writers, manage projects from start to finish, and collaborate with cross-functional teams to meet deadlines and regulatory expectations.