Associate Director, Disclosure Quality & Operations, Hybrid
$142,400–$224,100 year
HybridNorth Wales, Pennsylvania, United States or Rahway, New Jersey, United States
Job Summary
Oversee the preparation, quality control, and submission of clinical and regulatory documents while coordinating with stakeholders to ensure compliance and timely completion. Supervise the creation, review, and redaction of clinical documents across multiple therapeutic areas, verifying accuracy against regulatory guidance and privacy standards. Lead the collection and analysis of metrics to diagnose root causes and drive corrective actions through process improvements and enhanced training programs. Forecast and allocate resources for deliverables, manage project timelines, and support regulatory audits by ensuring documentation readiness. Mentor team members, manage hiring and workload, and develop Standard Operating Procedures to maintain inspection readiness and sustained quality.
Required Qualifications
- Bachelor's degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health)
- at least 5 years of relevant industry experience
- Fluent in American English
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat, SharePoint, and electronic document management systems
- Strong teamwork and leadership skills across organizational levels, including conflict resolution expertise and discretion
- Strong project management, organizational, and multitasking abilities
- Demonstrated ability to influence and lead in driving change in the organization
- Excellent communication, interpersonal and collaboration skills with the ability to work independently and in cross-functional teams
- Analytical mindset with problem-solving skills and ability to manage complex, ambiguous situations
- Strong commitment to quality, attention to detail, and ability to meet deadlines under pressure
- Adaptability to evolving technologies and processes within CRSC and regulatory environments
- Able to maintain confidentiality and adhere to regulatory and company standards
- Experience writing or able to critically analyze and interpret the content of drug and/or device clinical submission documents
- Ability to execute responsibilities with minimal oversight
- Ability to think strategically and objectively, and with creativity and innovation
- Good Clinical Practice (GCP)
- Medical Writing
- People Leadership
- Process Improvements
- Regulatory Compliance
- Stakeholder Management
- Critical Thinking
- Cross-Cultural Awareness
- Independent Thinking
- New Technology Integration
Desired Qualifications
- Expert-level proficiency in the US Food & Drug Administration trial disclosure or the European Medicines Agency's (EMA) and/or Health Canada publication of clinical information requirements
- Expert knowledge of regulatory disclosure intelligence and industry trends with the ability to assess the impact on business operations and shape effective strategies for new or modified requirements
- Ability to track metrics, analyze data, and establish automation tools
- Proven development, testing, implementation, and support of tools and systems
- Demonstrated experience identifying, designing, and implementing process improvements that increase efficiency, reduce cycle times, and strengthen operational effectiveness
- Strong quality mindset with experience applying quality principles, root cause analysis, and corrective actions to support compliant, inspection-ready deliverables
- Ability to influence stakeholders across functions to align on priorities, drive adoption of process improvements, and support sustained quality outcomes
- Continuous Improvement
- Standard Operating Procedure (SOP)
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