Director, Strategic Clinical & Regulatory Communications

Merck & Co.; Rahway (NJ); Presencial; USD 173.000 - 273.000; Jornada completa

Descripción de la vacante

Merck & Co. in Rahway, NJ seeks a Director of Clinical and Regulatory Strategic Communications to lead scientific writing across clinical programs and regulatory documents.

You will partner with stakeholders to ensure excellence, health literacy, and compliance in public-facing materials and internal submissions. The role requires deep clinical development knowledge, regulatory expertise, and leadership to guide teams through complex projects while navigating external partnerships and

Formación

• Experience leading complex regulatory documents per evolving requirements.
• Ability to analyze and present clinical data clearly per regulatory guidelines.
• Experience managing multiple projects and teams.

Responsabilidades

• Lead and oversee medical writing and regulatory activities across programs.
• Collaborate with cross-functional teams to ensure regulatory compliance.
• Mentor and provide project oversight to other medical writers.
• Identify opportunities to improve processes and standards.

Conocimientos

Medical Writing

Regulatory Writing

Project Leadership

Stakeholder Management

ICH GCP Guidance

Regulatory Compliance

Educación

Bachelor's degree or higher in health/science related field

Herramientas

Microsoft Office Suite

SharePoint

Descripción del empleo

Merck & Co. in Rahway, NJ seeks a Director of Clinical and Regulatory Strategic Communications to lead scientific writing across clinical programs and regulatory documents.

You will partner with stakeholders to ensure excellence, health literacy, and compliance in public-facing materials and internal submissions. The role requires deep clinical development knowledge, regulatory expertise, and leadership to guide teams through complex projects while navigating external partnerships and