Director, Strategic Clinical & Regulatory Communications

MSD; Guaduas; Presencial; COP 550 785 000 - 866 883 000; Tempo integral

Resumo da oferta

MSD seeks a Director of Clinical and Regulatory Strategic Communications to lead and shape regulatory communications, provide scientific oversight, and mentor medical writing teams across multiple programs. This role drives compliance, regulatory strategy, and cross-functional collaboration to advance the development portfolio.

The position requires strong leadership, deep knowledge of ICH guidelines, and the ability to manage complex projects in a deadline-driven environment.

Qualificações

• Experience leading complex clinical regulatory documents per regulatory requirements.
• Strong ability to analyze clinical data and present it clearly in line with guidelines.
• Proven leadership across teams and ability to mentor others.

Responsabilidades

• Lead, envision, and plan regulatory communications across programs and therapeutic areas.
• Provide scientific oversight for document development and regulatory strategy.
• Mentor medical writers and manage workload and performance.
• Escalate issues that could impact timelines, quality, or compliance.

Conhecimentos

Medical Writing

Regulatory Writing

Project Leadership

Project Management

Regulatory Compliance

ICH GCP Guidelines

Stakeholder Management

Data Analysis

Decision Making

Collaborative Leadership

Adaptability

Ethical Standards

Formação académica

Bachelor’s degree or higher in health/science

7+ years medical writing/industry experience

Descrição da oferta de emprego

MSD seeks a Director of Clinical and Regulatory Strategic Communications to lead and shape regulatory communications, provide scientific oversight, and mentor medical writing teams across multiple programs. This role drives compliance, regulatory strategy, and cross-functional collaboration to advance the development portfolio.

The position requires strong leadership, deep knowledge of ICH guidelines, and the ability to manage complex projects in a deadline-driven environment.