Director, Clinical and Regulatory Strategic Communications

Job Description

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.

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.

The Director of Clinical and Regulatory Strategic Communications:

• Is a 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).
• Is a pivotal scientific contributor and key collaborator on cross-functional teams with demonstrated team and project leadership.
• Applies advanced critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics, external partnerships, collaborations, and key strategic engagements.
• Acts as escalation point for issues that could impact timelines, quality, or compliance.
• Identifies and/or leads initiatives to improve medical writing processes and standards; provides expertise and/or strategic direction for use or development of Medical Writing (MW)-specific tools and technology platforms; may serve as a resource for this work internally and externally, as appropriate.
• Applies deep expertise in clinical development, global and relevant regulations, disease areas, and company products. Demonstrates comprehensive knowledge of the pharmaceutical landscape beyond clinical research and provides insight into regulatory strategy and emerging industry trends.
• Provides 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 (e.g., protocols, clinical study reports, key clinical submission documents) and/or public-facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) 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

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Required Skills:

Adaptability, Business Decisions, Collaborative Leadership, Data Analysis, Decision Making, Ethical Standards, ICH GCP Guidelines, Medical Writing, Project Leadership, Project Management, Regulatory Compliance, Regulatory Writing, Stakeholder Management

Preferred Skills:

Clinical Research, Clinical Trials Operations, Technical Knowledge

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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