Senior Director, Clinical and Regulatory Strategic Communications - Hybrid
Merck
June 26, 2026
Remote friendly (Upper Gwynedd, PA)
United States
Corporate Functions
Senior Director, Strategy, Technology & Operations (CRSC)
Key Responsibilities
- Partner with Head of CRSC; lead annual strategic planning and priority-setting.
- Establish governance (forums, decision frameworks, initiative tracking) and coordinate cross-functionally (Clinical Development, Regulatory Affairs, Data/IT, Quality).
- Develop executive communications; translate strategies into programs, milestones, and measurable outcomes.
- Build dashboards, metrics, and reporting; lead change management and adoption of new processes/technologies.
- Define workforce strategy to support evolving AI/digital/operational capabilities.
- Lead CRSC technology and innovation roadmap; oversee tool development/implementation/optimization.
- Guide technology investments (build vs buy; vendor selection/oversight) and ensure alignment with regulatory requirements, quality standards, and inspection readiness.
- Identify and implement AI use cases (draft generation, summarization, review support, document comparison); establish responsible AI governance.
- Develop prompt libraries/workflows/training; define and track KPIs (cycle time, quality, efficiency).
Qualifications
- Bachelor’s+ (health/scientific/technology or related) and 15+ years pharma/biotech experience (e.g., medical writing, regulatory communications, clinical development).
- Deep CTD regulatory document assembly/quality/submission/transmission expertise; global/local disclosure laws; end-to-end drug development & clinical trial processes.
Preferred
- Digital transformation/technology modernization; automation, data/analytics enablement; pragmatic AI adoption with governance.
Required Skills
- Interpersonal/communications; decision-making/analytics; lead complex topics and matrix environments; problem solving/conflict resolution; GCP/ICH and corporate policy expertise.
Benefits (explicitly stated)
- Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).
Key Responsibilities
- Partner with Head of CRSC; lead annual strategic planning and priority-setting.
- Establish governance (forums, decision frameworks, initiative tracking) and coordinate cross-functionally (Clinical Development, Regulatory Affairs, Data/IT, Quality).
- Develop executive communications; translate strategies into programs, milestones, and measurable outcomes.
- Build dashboards, metrics, and reporting; lead change management and adoption of new processes/technologies.
- Define workforce strategy to support evolving AI/digital/operational capabilities.
- Lead CRSC technology and innovation roadmap; oversee tool development/implementation/optimization.
- Guide technology investments (build vs buy; vendor selection/oversight) and ensure alignment with regulatory requirements, quality standards, and inspection readiness.
- Identify and implement AI use cases (draft generation, summarization, review support, document comparison); establish responsible AI governance.
- Develop prompt libraries/workflows/training; define and track KPIs (cycle time, quality, efficiency).
Qualifications
- Bachelor’s+ (health/scientific/technology or related) and 15+ years pharma/biotech experience (e.g., medical writing, regulatory communications, clinical development).
- Deep CTD regulatory document assembly/quality/submission/transmission expertise; global/local disclosure laws; end-to-end drug development & clinical trial processes.
Preferred
- Digital transformation/technology modernization; automation, data/analytics enablement; pragmatic AI adoption with governance.
Required Skills
- Interpersonal/communications; decision-making/analytics; lead complex topics and matrix environments; problem solving/conflict resolution; GCP/ICH and corporate policy expertise.
Benefits (explicitly stated)
- Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).