Director; Ophthalmology), Clinical and Regulatory Strategic Communications; CRSC

Director (Ophthalmology), CRSC

The Clinical and Regulatory Strategic Communications (CRSC) department within 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 CRSC 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 CRSC:

• 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 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.

Qualifications

Required:

Bachelor's degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 7+ years relevant medical writing or industry experience. Additionally, ophthalmology experience (industry and/or academia) is required, preferably in retinal diseases, including age-related macular degeneration (AMD), retinal vein occlusion (RVO), and/or diabetic macular edema (DME).

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 ICH guidance (e.g. 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

Required Skills:

Academic Presentations, Adaptability, Clinical Data, Clinical Development, Clinical Research, Clinical Study Design, Clinical Trials, Coaching, Conflict Resolution, Critical Thinking, Data Analysis, Decision Making, Drug Development, Ethical Standards, Good Clinical Practice (GCP), Health Literacy, Informed Consent, Macular Degeneration, Medical Writing, Microsoft Office, Stakeholder Alignment, Strategic Planning

Preferred

Skills:

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