Senior Medical Writer (Remote) - Regulatory Lead

MMS; Jersey City (NJ); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

MMS is a data-focused CRO delivering regulatory and clinical writing support to life sciences. The Medical Writer will analyze literature, prepare study protocols, manuals, and reports with rigorous scientific quality and minimal bias.

Responsibilities include timely writing, managing assignments, and mentoring junior writers while coordinating with clients to deliver polished manuscripts and regulatory documents.

Qualifikationen

• 3–5 years of regulatory writing and clinical medical writing experience.
• Bachelor's, Master's, or PhD in scientific/medical discipline.
• Experience leading and managing teams with aggressive timelines.
• Familiarity with clinical study reports and regulatory submissions is a plus.

Aufgaben

• Critically evaluate literature to select primary materials for study design and bias avoidance.
• Write and edit clinical development documents, study reports, and regulatory submissions.
• Maintain timelines, manage writing assignments, and ensure timely delivery.
• Mentor writers and coordinate with clients and project teams.

Kenntnisse

Regulatory writing

Clinical writing

Project leadership

Mentoring

Excellent writing skills

MS Word

MS Excel

MS PowerPoint

Communication skills

Ausbildung

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

Tools

MS Word

MS Excel

PowerPoint

Jobbeschreibung

MMS is a data-focused CRO delivering regulatory and clinical writing support to life sciences. The Medical Writer will analyze literature, prepare study protocols, manuals, and reports with rigorous scientific quality and minimal bias.

Responsibilities include timely writing, managing assignments, and mentoring junior writers while coordinating with clients to deliver polished manuscripts and regulatory documents.