Director, Clinical and Regulatory Strategic Communications
About The Position
The Clinical and Regulatory Strategic Communications department within Global Clinical Trial Operations creates and delivers high-quality regulated content for the development pipeline and enables data sharing. As a strategic partner, the department ensures 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 programs and therapeutic areas in support of the company portfolio. The Director serves as a lead subject matter expert in medical writing, a pivotal scientific contributor and cross-functional collaborator, and an escalation point for issues affecting timelines, quality, or compliance. The role applies deep expertise in clinical development, relevant global regulations, disease areas, and company products. It contributes insight into regulatory strategy and industry trends, leads or supports initiatives to improve medical writing processes and standards, and provides strategic direction for medical-writing tools and technology. The Director also mentors and coaches medical writers and may manage direct reports, including workload, professional development, and performance.
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, and/or authoring complex clinical regulatory documents, such as protocols, clinical study reports, and key clinical submission documents, and/or public-facing documents, such as informed consent forms, clinical trial registration and results postings, and plain language summaries, in accordance 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 and 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 and problem-solving capabilities, including the 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, clinical research, and clinical trial processes.
- Ability to interpret and apply International Council for Harmonisation 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, plus willingness to learn and adapt to emerging technology.
Nice To Haves
- Experience managing direct reports.
- Clinical research, clinical trials operations, and technical knowledge.
Responsibilities
- Lead, envision, and plan projects in collaboration with 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 programs and therapeutic areas.
- Design, plan, author, edit, and review accurate, clear, high-quality documents using medical writing best practices, including lean writing and health literacy principles.
- Serve as a scientific contributor and collaborator on cross-functional teams, providing team and project leadership.
- Apply critical thinking, problem solving, and negotiation to implement solutions to complex medical writing challenges involving documents, processes, tools, teams, partnerships, and strategic engagements.
- 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 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 other medical writers.
- Potentially manage direct reports, including their workload, professional development, and performance management.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including a 401(k).
- Paid holidays, vacation, and compassionate and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Director
