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Senior Director, Clinical and Regulatory Strategic Communications

Job in Edison, Middlesex County, New Jersey, 08818, USA
Listing for: Jobtailor
Full Time position
Listed on 2026-08-02
Job specializations:
  • Business
    Change Management
Salary/Wage Range or Industry Benchmark: 180000 - 240000 USD Yearly USD 180000.00 240000.00 YEAR
Job Description & How to Apply Below

Responsibilities

  • Serve as a strategic partner to the Head of CRSC, ensuring alignment of priorities, resources, and execution
  • Lead annual strategic planning, operating model development, and priority-setting for CRSC
  • Establish and maintain governance structures, including leadership forums, decision frameworks, and initiative tracking
  • Drive coordination across CRSC and partner functions (e.g., Clinical Development, Regulatory Affairs, Data/IT, Quality)
  • Develop executive‑level communications (e.g., leadership updates, town halls, strategic messaging)
  • Translate enterprise and functional strategies into structured programs, milestones, and measurable outcomes
  • Support cross-functional CRSC initiatives that enhance efficiency, quality, and scalability
  • Develop and oversee department dashboards, metrics, and reporting frameworks
  • Ensure effective change management, communication, and adoption of new processes and technologies
  • Support the Head of CRSC in aligning initiatives with broader GCTO transformation efforts
  • Define workforce strategies to support evolving AI, digital, and operational capabilities
  • Foster a culture of innovation, accountability, and continuous improvement
Requirements
  • Bachelor’s degree or higher preferably in a health, scientific, technology or relevant discipline (e.g., life sciences, pharmacy, medicine, public health)
  • At least 15+ years relevant pharmaceutical or biotech industry experience (e.g., medical writing, regulatory communications, or clinical development)
  • Expertise and thorough knowledge of the regulatory requirements and technical specifications for the assembly, structure, content, formatting, quality control and submission/transmission of all documents for regulatory submissions using the CTD process
  • Expertise and understanding of global and local disclosure laws, end‑to‑end drug development, and clinical trial processes
  • Experience in planning and leading strategic initiatives
Certifications & Qualifications
  • Bachelor’s degree
  • Advanced degree
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Position Requirements
10+ Years work experience
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