Lead Medical Writer - Regulatory & Clinical Strategy

MMS Holdings Inc; Richmond (VA); À distance; USD 90 000 - 120 000; Plein temps

Résumé du poste

MMS Holdings Inc is seeking an experienced Medical Writer to critically evaluate literature, develop regulatory documents, and manage writing projects with minimal supervision. The role involves leading authoring efforts for clinical study reports and related modules, mentoring junior writers, and coordinating with clients to ensure timely delivery.

The candidate will demonstrate strong scientific writing skills, a deep understanding of regulatory requirements, and the ability to manage complex

Qualifications

• 3+ years in the pharmaceutical industry
• 3–5 years regulatory/clinical writing experience
• Advanced degree in science or medicine (Bachelors, Masters or Ph.D.)
• Lead author on substantial regulatory documents
• Experience coordinating projects and teams under tight timelines
• Familiarity with regulatory submissions and ICH guidelines
• Strong writing, organizational, and multitasking abilities
• Proficiency with MS Word, Excel, and PowerPoint

Responsabilités

• Critically evaluate literature to select primary materials for study design and regulatory rigor
• Write and edit clinical development documents (protocols, investigators' brochures, study reports, consent forms)
• Prepare modules 2.5 and 2.7 documents, presentations, and publications
• Manage timelines and workflow for writing tasks
• Mentor other medical writers and project team members
• Coordinate directly with clients to ensure project success
• Maintain high-quality client service and communicate effectively

Connaissances

Regulatory writing

Medical writing

Clinical writing

Project leadership

Formation

Bachelor's/Master's/Ph.D. in scientific/medical discipline

Outils

MS Word

Excel

PowerPoint

Description du poste

MMS Holdings Inc is seeking an experienced Medical Writer to critically evaluate literature, develop regulatory documents, and manage writing projects with minimal supervision. The role involves leading authoring efforts for clinical study reports and related modules, mentoring junior writers, and coordinating with clients to ensure timely delivery.

The candidate will demonstrate strong scientific writing skills, a deep understanding of regulatory requirements, and the ability to manage complex