Job Description
The Director, Training & Documentation provides strategic leadership for training, documentation governance, and process excellence within Safety Data Management (SDM). This role ensures global compliance, inspection readiness, and operational effectiveness across safety case processing and medical coding activities through standardized processes, quality oversight, and continuous improvement initiatives.
Primary Responsibilities Strategic Leadership & Capability Development
• Lead global Safety Data Management (SDM) processes, documentation governance, and training programs to ensure compliance and inspection readiness.
• Establish functional objectives and drive capability development aligned with organizational priorities.
• Drive process simplification, standardization, and transformation initiatives in response to evolving business and regulatory requirements.
• Ensure business processes continuously adapt to system enhancements and technology changes.
• Monitor industry, regulatory, and technology trends to drive continuous improvement and innovation.
• Provide strategic oversight of safety operations, promoting global consistency, operational excellence, and future-focused digital capabilities.
Quality, Compliance & Process Excellence
• Govern SDM processes and ensure alignment with enterprise standards, quality requirements, and regulatory expectations.
• Ensure compliance with SOPs, ICH-GCP, GxP, and applicable global regulations.
• Oversee global ICSR governance, case management, and medical coding activities to drive quality, consistency, and risk mitigation.
• Lead quality oversight activities, including trend analysis, quality reviews, and retrospective assessments.
• Support audits, inspections, and CAPA activities; serve as an escalation point for significant compliance issues and regulatory findings.
• Drive global alignment of documentation, training, and operational governance practices across regions.
Technology & Business Partnership
• Partner with Global Clinical Safety & Pharmacovigilance, GDIA, IT, and vendors to enhance systems, automation, and digital capabilities.
• Provide strategic input into platform governance, system functionality, data flows, and technology roadmaps.
• Develop and evaluate business cases supporting system enhancements and release prioritization.
• Lead planning and execution of technology enablement initiatives and system releases, ensuring operational readiness and compliance.
• Foster strong stakeholder partnerships to align priorities and ensure effective delivery of business objectives.
People Leadership
• Lead, develop, and inspire high-performing global teams and leaders.
• Set clear goals, priorities, and performance expectations aligned with organizational strategy.
• Drive talent development through coaching, mentoring, succession planning, and career development initiatives.
• Lead recruiting, hiring, workforce planning, and performance management activities.
• Manage budgets, resources, and global staffing models to support business priorities.
• Promote a culture of inclusion, collaboration, accountability, and continuous improvement.
Required Skills Education & Experience
• Bachelor’s degree in Life Sciences or a related field; advanced degree (Master’s, PharmD, PhD) preferred.
• Minimum 10 years of relevant experience, or 8 years with an advanced degree, including experience within the biopharmaceutical industry.
• Minimum 3 years of people leadership experience, including direct and/or matrix team management.
• Deep expertise in pharmacovigilance, safety data management, ICSR processes, and medical coding.
• Strong knowledge of global safety regulations, GxP requirements, and inspection readiness practices.
• Experience leading quality, audit, compliance, and CAPA programs.
• Knowledge of safety systems, databases, automation solutions, and reporting tools.
• Demonstrated strategic planning, analytical, and problem-solving capabilities.
• Proven ability to lead cross-functional global teams and influence senior stakeholders.
• Strong communication, change management, stakeholder management, and organizational leadership skills.
Leadership Competencies
• Strategic Thinking
• Enterprise Leadership
• Cross-Functional Collaboration
• Talent Development
• Change Leadership
• Operational Excellence
• Stakeholder Management
• Continuous Improvement
Required Skills: Adaptability, Adaptability, Case Management, Clinical Data Management, Data Validation, Decision Making, eCRF, Ethical Standards, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Medical Insurance Coding, Mentoring Staff, Metadata Management, Mitigated Risks, Organizational Performance Management, People Leadership, Pharmacovigilance, Process Standardization, Psychological Safety, Risk Mitigation Strategies, Standard Operating Procedure (SOP), Strategic Leadership, Strategic Thinking, Study Data Tabulation Model (SDTM), System Validation {+ 1 more} Preferred Skills:
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Employee Status: Regular Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements: Hybrid Shift:
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Job Posting End Date: 08/13/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.