Senior Medical Writer: Regulatory Lead for Clinical Programs

MMS Holdings Inc; St. Louis (MO); A distancia; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

MMS Holdings Inc in St. Louis, MO is seeking a Medical Writer with 3+ years in pharmaceutical regulatory writing to critically evaluate literature and prepare clinical development documents and submission-ready reports.

You'll mentor junior writers, coordinate with clients, and ensure adherence to regulatory standards (ICH, GCP) across study protocols, CSR, SBAs, and modules 2.5–2.7 while meeting aggressive timelines.

Formación

• 3+ years of experience in pharmaceutical industry and regulatory writing
• Experience leading regulatory submissions and clinical study reports
• Strong writing skills and ability to meet aggressive timelines
• Expertise with client templates and regulatory style guides
• Excellent organizational and multitasking abilities

Responsabilidades

• Critically evaluate, analyze, and interpret medical literature to select primary materials for study design and regulatory needs
• Write and edit clinical development documents (protocols, ICH modules, reports, patient consent forms) and preparation of publications
• Meet deadlines and manage multiple writing assignments efficiently
• Coordinate with clients and internal teams to ensure project alignment and quality
• Mentor junior writers and contribute to team knowledge and processes
• Apply regulatory standards and guidelines (GCP, ICH) across documents

Conocimientos

Regulatory writing

Clinical writing

MS Word

MS Excel

PowerPoint

Project leadership

ICH guidelines

Educación

Bachelor's degree in life sciences

Master's degree or PhD in scientific discipline

Herramientas

MS Word

Descripción del empleo

MMS Holdings Inc in St. Louis, MO is seeking a Medical Writer with 3+ years in pharmaceutical regulatory writing to critically evaluate literature and prepare clinical development documents and submission-ready reports.

You'll mentor junior writers, coordinate with clients, and ensure adherence to regulatory standards (ICH, GCP) across study protocols, CSR, SBAs, and modules 2.5–2.7 while meeting aggressive timelines.