Director, Clinical & Regulatory Communications Strategy

Merck; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Job summary

Merck's Clinical and Regulatory Strategic Communications group seeks a Director who leads scientific writing for clinical regulatory and public-facing documents across programs, applying lean writing and health literacy principles to ensure accuracy, clarity, and regulatory compliance.

The role collaborates with cross‑functional teams, mentors medical writers, manages multiple complex projects to timelines, interprets ICH guidelines, and helps shape regulatory strategy while advancing a culture

Qualifications

• Bachelor’s degree or higher in a health, scientific, or relevant discipline.
• 7+ years medical writing or industry experience.
• Experience independently leading and authoring complex clinical regulatory and/or public-facing documents.
• Ability to interpret regulatory requirements and present data clearly.
• Strong decision-making and leadership across teams.

Responsibilities

• Lead design, planning, authoring, editing, and review of high-quality documents reflecting medical writing best practices.
• Serve as a key scientific contributor and cross-functional team collaborator on projects.
• Apply critical thinking to implement innovative solutions across MW scope of work.
• Act as escalation point for issues impacting timelines, quality, or compliance.
• Mentor and provide oversight for other medical writers; may manage direct reports.

Skills

Medical writing leadership

Cross-functional collaboration

Regulatory writing

ICH GCP knowledge

Editorial review

Project management

Attention to detail

Negotiation

Education

Bachelor’s degree or higher in health/science

Tools

Microsoft Office

SharePoint

Job description

Merck's Clinical and Regulatory Strategic Communications group seeks a Director who leads scientific writing for clinical regulatory and public-facing documents across programs, applying lean writing and health literacy principles to ensure accuracy, clarity, and regulatory compliance.

The role collaborates with cross‑functional teams, mentors medical writers, manages multiple complex projects to timelines, interprets ICH guidelines, and helps shape regulatory strategy while advancing a culture