Process and Procedural Document Specialist, Associate Director/Sr. Manager

Role Overview

• Lead a matrix team comprised of global and/or local subject matter experts, business process owners, and key stakeholders, with minimal assistance, in the development, revision, process mapping, process enhancements, implementation and maintenance of process quality standards and procedural documentation (policies, SOPs and associated documents) for approximately 10,000 colleagues across client clinical, medical, safety, regulatory and enterprise quality management system global processes.
• Function as a key subject matter expert in the document management model, quality management system, and quality standards. Providing advice and recommendations to global and local colleagues on process enhancement and continuous improvement project teams.
• Provide strategic recommendations regarding process design, documentation development, change management and supporting systems by understanding the business, organization and associated responsible roles.
• Plan and manage process development projects to address the full life cycle: requirements and policy setting; process design, documentation and training development and delivery; change management planning and deployment; and transition to an oversight system that incorporates performance monitoring and continuous improvement once the new/revised process is fully operational.
• Applies knowledge and understanding of global regulations in a GxP environment and produces processes and related documentation that meets regulatory requirements, supports corporate compliance, is inspection ready and is designed with operational effectiveness in mind and contains measurable controls where applicable.
• Identifies areas of training focus and collaborate closely with training developers on training strategies and plans.
• Contribute to compliance and audit/inspection readiness strategies and plans.
• Participate in regulatory inspections, external PV license partner audits, and other internal audits by being the liaison for documentation requests and responding to findings.
• Participate in integration activities for process and documentation analysis of the acquiree's process documentation.
• Evaluate global procedural documentation against evolving industry/regulatory requirements and expectations, audit/inspection findings, business needs, higher level corporate policies, changes in industry standards and client feedback and trends, and make recommendations for changes when necessary.
• Manage queries and exceptions from the organization related to assigned policies/SOPs.
• Understand relational database functionality and serve as a subject matter expert in regard to process design.

Requirements

• A minimum of a BA or BS is required, advanced degree in relevant field desirable.
• Degree or professional certification in process design or change management, or equivalent experience.
• A minimum 5-8 years of experience in design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical).
• Demonstrated process development expertise.
• Ability to manage multi-phase moderately complex projects with multiple contributors/collaborators, facilitate cross functional global or enterprise teams, optimize subject matter involvement, and interacts at all levels in a matrix environment.
• Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills.
• Ability to lead by example, demonstrating client values and effectively implement strategies through influence and persuasion.
• Demonstrate ability to adapt to changing situations and work well under pressure.
• Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project); tools for process design and mapping; and systems for document management, publishing, communication, and learning management.
• Understanding of the fundamentals of electronic publishing of procedural documents.
• Strong process management, project management and verbal and written communication skills.
• Strong orientation to detail and ability to function independently as appropriate.
• In-depth understanding of pharmaceutical business processes (i.e., safety, regulatory, medical, clinical trials and/or enterprise quality management system) and regulations, guidelines and industry standards for compliance.
• Ability to perform analysis of processes and procedures by using process development and process management techniques.