Senior Medical Writer - Regulatory Submissions Lead

Integrated Resources Inc.; Madison (NJ); Vor Ort; USD 75.000 - 95.000; Vollzeit

Zusammenfassung

A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables. Ideal candidates will possess a strong scientific background and experience in medical writing or pharmaceutical development.

Qualifikationen

• 3+ years of experience in medical writing or pharmaceutical development.
• Strong functional literacy with effective communication skills.
• Experience in creating clinical/regulatory documents and navigating regulatory requirements.

Aufgaben

• Prepare Clinical Overviews and regulatory submissions for drug products.
• Lead cross-functional teams to ensure consistency and quality of documents.
• Serve as a point of contact for project-related queries and issues.

Kenntnisse

Analytical skills

Time management

Cross-functional collaboration

Strategic planning

Project management

Ausbildung

PharmD/PhD or MSc/BSc

BS degree

Jobbeschreibung

A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables. Ideal candidates will possess a strong scientific background and experience in medical writing or pharmaceutical development.