Director, Clinical and Regulatory Strategic Communications

MSD • Rahway, PA

8d

About The Position

The Clinical and Regulatory Strategic Communications department within Global Clinical Trial Operations creates and delivers high-quality regulated content supporting the development pipeline and data sharing. It partners across the company to ensure excellence and compliance with applicable laws while incorporating health literacy principles into public-facing materials.

The Director leads, envisions, and plans projects, engaging strategically with stakeholders across departments, divisions, and the company. The role provides scientific expertise and oversight for preparing and executing clinical regulatory and public-facing documents across multiple programs and therapeutic areas. It serves as a lead subject matter expert in document design, planning, authoring, editing, and review, and as a pivotal scientific contributor and collaborator on cross-functional teams. The Director applies advanced critical thinking, problem-solving, and negotiation skills to address complex challenges, acts as an escalation point for issues affecting timelines, quality, or compliance, and leads or supports initiatives to improve medical writing processes, standards, and technology. The role also provides mentorship, coaching, and project oversight to medical writers and may manage direct reports, including workload, professional development, and performance management.

Requirements

• Bachelor’s degree or higher, preferably in a health, scientific, or relevant discipline such as life sciences, pharmacy, medicine, or public health.
• At least 7 years of relevant medical writing or industry experience.
• Experience independently leading, managing, overseeing, or authoring complex clinical regulatory documents and/or public-facing documents in line with company and evolving regulatory requirements.
• Ability to critically analyze and present clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines.
• Strong decision-making skills and ability to influence and take a broader view of issues to maximize organizational benefit or impact.
• Experience managing multiple complex projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
• Demonstrated critical thinking, problem-solving, innovation, influence, and ability to drive change.
• Demonstrated effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision-making.
• Expert knowledge and thorough understanding of end-to-end drug development, clinical research, and clinical trial processes.
• Ability to interpret and apply ICH guidance, including Good Clinical Practice, global and local disclosure laws, and corporate policies.
• Excellent oral and written communication and presentation skills.
• Technical expertise in commonly used office applications, such as Microsoft Office Suite, and shared document systems, such as SharePoint, with willingness to learn and adapt to emerging technology.

Nice To Haves

• Experience managing direct reports.

Responsibilities

• Lead, envision, and plan strategic communications projects, engaging stakeholders across departments, divisions, and the company.
• Provide scientific expertise and oversight for the preparation and execution of clinical regulatory and public-facing documents across multiple programs and therapeutic areas.
• Design, plan, author, edit, and review accurate, clear, high-quality documents in accordance with medical writing best practices, including lean writing and health literacy.
• Contribute scientific expertise and collaborate on cross-functional teams, providing team and project leadership.
• Apply critical thinking, problem-solving, and negotiation skills to implement innovative solutions to complex medical writing challenges.
• Act as an escalation point for issues that could affect timelines, quality, or compliance.
• Identify or lead initiatives to improve medical writing processes and standards, and provide expertise or strategic direction for medical-writing-specific tools and technology platforms.
• Apply expertise in clinical development, global and relevant regulations, disease areas, and company products, and provide insight into regulatory strategy and emerging industry trends.
• Provide scientific and operational mentorship, coaching, and project oversight to support other medical writers.
• May manage direct reports, including workload, professional development, and performance management.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Director