Regulatory & Medical Writing Lead - Mentorship & Strategy

MMS; Phoenix (AZ); On-site; USD 110,000 - 160,000; Full time

Job summary

MMS is an award-winning, data-focused clinical research organization (CRO). We are a Great Place to Work Certified organization, recognized for our culture and industry-leading employee retention.

We support pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a

Qualifications

• 6+ years’ experience in Regulatory and Medical Writing or similar field.
• Proven experience mentoring and developing Medical Writing professionals.
• Ability to anticipate and resolve potential client demands.
• Demonstrates managerial skill and experience.
• Familiarity with ISO 9001, ISO 27001, FDA, and GCP.

Responsibilities

• Mentor medical writing staff and lead project teams from start to finish.
• Manage client meetings and CRM effectively.
• Incorporate regulatory updates into deliverables with accuracy.
• Identify and mitigate project risks; resolve client feedback promptly.

Skills

Regulatory knowledge

Medical writing

Project management

Client meetings

CRM

Mentorship

Leadership

MS Office

Problem solving

Communication

ISO 9001 familiarity

ISO 27001 familiarity

GCP familiarity

FDA Part 11

AI-assisted authoring

Clinical trial knowledge

Education

Bachelor's in scientific/clinical field

Master's or PhD preferred

Tools

MS Office

CRM software

Job description

MMS is an award-winning, data-focused clinical research organization (CRO). We are a Great Place to Work Certified organization, recognized for our culture and industry-leading employee retention.

We support pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a