Senior Regulatory Writing Lead | Mentorship & Strategy

MMS; Jersey City (NJ); Presencial; USD 120 000 - 170 000; Tempo integral

Resumo da oferta

MMS is a data-focused clinical research organization seeking an experienced Medical Writing Lead to guide regulatory writing within trials and submissions. The role emphasizes mentorship, process improvement, and collaboration with cross-functional teams across a global CRO.

You will steward complex documents, ensure regulatory compliance, and drive quality across deliverables. Ideal candidates hold advanced scientific credentials, 6+ years in regulatory/medical writing, and strong leadership

Qualificações

• Regulatory writing expertise with familiarity in clinical documentation.
• Mentor and guide Medical Writing professionals.
• Proficient with QC and MW tools; understands regulatory updates.
• Experience with AI-assisted authoring technologies.
• Strong client-facing skills and CRM experience.
• Ability to manage projects end-to-end.

Responsabilidades

• Lead regulatory writing projects from initiation to submission.
• Mentor junior writers and coordinate with SMEs.
• Manage client meetings and regulatory deliverables.

Conhecimentos

Regulatory writing

Clinical documentation

Regulatory updates

AI-assisted authoring

Client meetings & CRMs

Project leadership

Mentoring teams

Document SME

QC & MW tools

Risk management

Formação académica

Master's or PhD preferred

Science/medical/clinical background

Ferramentas

MS Office

MW tools

Descrição da oferta de emprego

MMS is a data-focused clinical research organization seeking an experienced Medical Writing Lead to guide regulatory writing within trials and submissions. The role emphasizes mentorship, process improvement, and collaboration with cross-functional teams across a global CRO.

You will steward complex documents, ensure regulatory compliance, and drive quality across deliverables. Ideal candidates hold advanced scientific credentials, 6+ years in regulatory/medical writing, and strong leadership