Director, Ophthalmology – Clinical and Regulatory Strategic Communications

MSD

Director of Clinical and Regulatory Strategic Communications overseeing high-quality regulated content creation for development pipeline. Engaging with stakeholders to ensure regulatory compliance and health literacy in communications.

Posted 6/2/2026full-timeRahway • New Jersey • 🇺🇸 United StatesLead💰 $173,200 - $272,600 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
The Director of CRSC leads, envisions, and plans projects, engaging strategically with key stakeholders across departments, divisions, and company
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
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.

Requirements

What you’ll need

Bachelor’s degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health)
at least 7+ years relevant medical writing or industry experience
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)
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.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingclinical regulatory documentsclinical study reportsprotocolsinformed consent formsclinical trial registrationdata analysisdrug developmentclinical researchICH guidance

Soft Skills

critical thinkingproblem solvingdecision makingleadershipnegotiationinfluenceproject managementmentorshipcommunicationcollaboration