Senior Medical Writer: Regulatory Strategy & Leadership

Merck; Upper Gwynedd Township (Montgomery County); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Health benefits

Retirement plan (401(k))

Paid holidays

Vacation

Sick leave

Job summary

Merck in Rahway, NJ is seeking an experienced Medical Writer to independently prepare clinical regulatory and public-facing documents in line with regulatory requirements and health literacy best practices. You will lead cross-functional teams, mentor junior writers, and drive quality, timelines, and compliance across study documents.

You will apply deep knowledge of clinical development, regulatory standards, and writing tools to deliver protocols, study reports, participant narratives,

Qualifications

• Bachelor’s degree in health, science, or related field.
• 3+ years of medical writing or industry experience.

Responsibilities

• Lead multiple writing projects in a deadline-driven environment and coordinate cross-functional teams.
• Interpret clinical data clearly, objectively, and per regulatory guidelines with minimal supervision.
• Demonstrate critical thinking and problem-solving capabilities in writing and processes.
• Resolve conflicts and negotiate effectively within cross-functional teams.
• Adapt to changing project needs to keep teams aligned and on track.
• Communicate effectively, with strong verbal and written presentation skills.
• Utilize MS Office and SharePoint and adapt to new writing tools and platforms.

Skills

Project management

Clinical data interpretation

Critical thinking

Negotiation

Communication

Microsoft Office

Education

Bachelor’s degree (life sciences)

Tools

SharePoint

MS Office

Job description

Merck in Rahway, NJ is seeking an experienced Medical Writer to independently prepare clinical regulatory and public-facing documents in line with regulatory requirements and health literacy best practices. You will lead cross-functional teams, mentor junior writers, and drive quality, timelines, and compliance across study documents.

You will apply deep knowledge of clinical development, regulatory standards, and writing tools to deliver protocols, study reports, participant narratives,