Senior Medical Writer — Regulatory Content Leader

Merck; New Jersey; In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Merck is seeking a Clinical and Regulatory Medical Writer to prepare regulatory and public-facing documents in compliance with regulatory requirements and health literacy standards. The role involves leading cross-functional teams, applying lean writing, and mentoring junior writers to improve processes.

You will interpret clinical data, manage timelines, and contribute to the development of high-quality, compliant literature for development programs while navigating regulatory changes and

Competenze

• Bachelor’s degree in health, life sciences, pharmacy, or public health.
• 3+ years of medical writing or industry experience.
• Experience managing multiple writing projects in a deadline-driven environment.
• Ability to interpret clinical data clearly with regulatory compliance.
• Strong written and oral communication skills.

Mansioni

• Prepare clinical regulatory documents (e.g., protocols, clinical study reports, participant narratives, investigator's brochures).
• Prepare public-facing documents (e.g., informed consent forms, trial registrations, plain language summaries).
• Collaborate on cross-functional teams and lead project timelines and quality.
• Apply medical writing best practices and health literacy principles.
• Mentor less experienced writers and support team development.
• Advise on process improvements in medical writing workflows.

Conoscenze

Adaptability

Ethical Standards

ICH GCP Guidelines

Communication

Teamwork

Time Management

Mentorship

Conflict Resolution

Written Communication

Presentation Skills

Formazione

Bachelor's degree in health, life sciences, pharmacy, or public health

Strumenti

Microsoft Office Suite

SharePoint

Descrizione del lavoro

Merck is seeking a Clinical and Regulatory Medical Writer to prepare regulatory and public-facing documents in compliance with regulatory requirements and health literacy standards. The role involves leading cross-functional teams, applying lean writing, and mentoring junior writers to improve processes.

You will interpret clinical data, manage timelines, and contribute to the development of high-quality, compliant literature for development programs while navigating regulatory changes and