Director, Clinical and Regulatory Strategic Communications
MSD
Summary
The Clinical and Regulatory Strategic Communications department within Global Clinical Trial Operations (GCTO) creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.
Job description
The Director of Clinical and Regulatory Strategic Communications leads, envisions, and plans projects, engaging strategically with key stakeholders across departments, divisions, and company. The role provides scientific expertise and oversight for the preparation and execution of clinical regulatory and public-facing documents across multiple programs and therapeutic areas in support of the company portfolio.
Responsibilities
- Lead subject matter expert in the design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy).
- Pivotal scientific contributor and key collaborator on cross-functional teams with demonstrated team and project leadership.
- Apply advanced critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work while navigating project team dynamics, external partnerships, collaborations, and key strategic engagements.
- Act as escalation point for issues that could impact timelines, quality, or compliance.
- Identify and/or lead initiatives to improve medical writing processes and standards; provide expertise and/or strategic direction for use or development of Medical Writing-specific tools and technology platforms.
- Apply deep expertise in clinical development, global and relevant regulations, disease areas, and company products.
- Demonstrate comprehensive knowledge of the pharmaceutical landscape beyond clinical research and provide insight into regulatory strategy and emerging industry trends.
- Provide scientific and operational mentorship, coaching, and/or project oversight to support other medical writers.
- May manage direct reports including workload, professional development, and performance management.
Required Qualifications
- Bachelor's degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health).
- 7+ years relevant medical writing or industry experience.
Required Skills & Experience
- Experience independently leading, managing, overseeing, and/or authoring complex clinical regulatory and/or public-facing documents per 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.
- Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization.
- 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 and problem-solving capabilities with an ability to innovate, influence, and 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 and clinical research and clinical trial processes.
- Ability to interpret and apply International Council for Harmonisation (ICH) guidance (e.g. Good Clinical Practice (GCP)), global and local disclosure laws, and corporate policies.
- Excellent oral and written communication and presentation skills.
- Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.
Preferred Skills & Experience
- Experience managing direct reports.
Requirements
- Bachelor's degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health)
- 7+ years relevant medical writing or industry experience
- Experience independently leading, managing, overseeing, and/or authoring complex clinical regulatory and/or public-facing documents per 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
- Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization
- 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 and problem-solving capabilities with an ability to innovate, influence, and 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 and clinical research and clinical trial processes
- Ability to interpret and apply International Council for Harmonisation (ICH) guidance (e.g. Good Clinical Practice (GCP)), global and local disclosure laws, and corporate policies
- Excellent oral and written communication and presentation skills
- Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology
- Experience managing direct reports
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.