Strategic Regulatory & Medical Writing Leader

MMS; Austin (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

MMS Holdings, a data-focused clinical research organization, seeks a Senior Medical Writer to lead regulatory writing and ensure compliant, publication-ready documents. You will mentor teammates, manage complex deliverables, and collaborate with clients across the drug development continuum.

With a global footprint and commitment to best practices, you will drive process improvements, apply AI-assisted tools, and oversee end-to-end project execution from initiation to submission, ensuring

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.

Skills

Regulatory knowledge

Medical writing styles

QC & MW tools

AI-assisted authoring

Complex issue analysis

Strategic policy implementation

Team supervision/SME

Update impact awareness

Client meetings & CRMs

End-to-end project management

Risk mitigation

Client feedback handling

Education

Master's or PhD preferred

Bachelor's degree in science/medical field

Tools

MS Office

Job description

MMS Holdings, a data-focused clinical research organization, seeks a Senior Medical Writer to lead regulatory writing and ensure compliant, publication-ready documents. You will mentor teammates, manage complex deliverables, and collaborate with clients across the drug development continuum.

With a global footprint and commitment to best practices, you will drive process improvements, apply AI-assisted tools, and oversee end-to-end project execution from initiation to submission, ensuring