Job description
Key Responsibilities
Partner with submission managers to lead the creation of high-quality submission packages (eCTD, NeeS, Paper) using submission-ready documents that comply with both internal and external electronic submission guidelines. Ensure all submission assemblies meet the technical integrity standards required for health authority validation tools.
Lead and mentor internal and external publishing staff, providing training as needed. Support submission project teams in defining content requirements and timeline milestones to deliver right-first-time submissions. Proactively identify, assess, and resolve—or escalate—risks or issues that may affect the timely and successful delivery of regulatory submissions.
Track project status, daily production activities, and publishing anomalies to maintain accurate departmental metrics. Lead the development and documentation of publishing processes, including user acceptance testing for new or updated publishing tools, and delegate activities to publishing staff as appropriate. Serve as a subject matter expert for specific functions or processes, offering guidance to both internal teams and external stakeholders.
Review and enhance business processes, identifying areas for improvement and driving the implementation of effective solutions.
Requirements
Skills & Qualifications Experience in regulatory publishing. Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Medical, or related scientific discipline. Proficiency with Lorenz docu. Bridge, Liquent In. Sight Publisher, and global publishing tools. Experience using industry-standard electronic document management systems.
Proven track record in project management and team leadership.