Remote Senior Medical Writer — Regulatory Submissions Lead

MMS Holdings Inc; México; Hybride; MXN 480 000 - 720 000; Plein temps

Résumé du poste

MMS Holdings Inc, a data-focused CRO, seeks a Medical Writer to critically evaluate literature and craft regulatory documents including protocols, study reports, and safety summaries. You will lead writing projects, mentor junior writers, and coordinate with clients to meet aggressive timelines in a remote Mexico setting.

The ideal candidate has 3+ years in pharma regulatory writing, advanced degree, and strong skills in MS Word/Excel/PowerPoint.

Qualifications

• Minimum 3 years in pharmaceutical industry.
• 3–5 years of regulatory writing experience.
• Bachelor's/Master's/Ph.D. in scientific/medical field.
• Lead author on substantial clinical study protocols.
• Experience with regulatory submissions is a plus.

Responsabilités

• Evaluate and interpret medical literature to select primary materials for study design and regulatory documents.
• Write and edit clinical development documents (protocols, brochures, study reports, consent forms, summaries).
• Manage writing assignments and maintain timelines and workflow.
• Mentor writers and project team members on writing processes.
• Lead and coordinate with client teams to ensure timely delivery.

Connaissances

Regulatory writing

Project leadership

Excellent writing

Time management

Formation

Bachelor's/Master's/PhD in scientific/medical field

Outils

MS Word

MS Excel

PowerPoint

Description du poste

MMS Holdings Inc, a data-focused CRO, seeks a Medical Writer to critically evaluate literature and craft regulatory documents including protocols, study reports, and safety summaries. You will lead writing projects, mentor junior writers, and coordinate with clients to meet aggressive timelines in a remote Mexico setting.

The ideal candidate has 3+ years in pharma regulatory writing, advanced degree, and strong skills in MS Word/Excel/PowerPoint.