Process Documentation Designer

Purpose:
Work with colleagues, customers, and stakeholders on projects relating to process enhancement and continuous improvement in the context of procedural documentation development (policies, standards, standard operating procedures (SOPs) and supporting documentation) for the Medical organization worldwide.

Primary Responsibilities:
- Play lead role with minimal/moderate assistance in business process analysis and design leading to development of new process standards.
- Follow outcomes-driven design principles. Ensure processes are designed according to agreed policy and business requirements in effort to achieve agreed objectives for quality, regulatory compliance, and operational effectiveness. Define appropriate performance standards (eg metrics).
- Ensure process projects are planned and managed 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 process is fully operational.
- Collaborate closely with PM and/or act directly to establish and maintain project plans, with appropriate controls defined for key deliverables.
- Collaborate with procedural documentation developers and/or act directly to develop procedural documentation, facilitate review and approval, publish, and communicate.
- Collaborate with training developers. Develop recommendations for training programs and performance support materials; develop materials as appropriate.
- Contribute to compliance and inspection readiness strategies and plans.
- Serve as a SME in regard to process design and change management. Make recommendations for improvement to methodology, infrastructure, and tools as appropriate.

Technical Skill Requirements:
- Expertise in methods for creating and managing organizational change including reengineering, change management, Instructional Systems Design, and quality systems development in a GxP environment (specifically GCPs).
- Demonstrated ability to analyze, evaluate, and understand global complex processes and systems quickly; synthesize information and concepts into written documents and diagrams; and identify gaps, issues, and opportunities for improvement.
- In-depth understanding of pharmaceutical business processes (safety, regulatory and clinical) and regulations, guidelines and industry standards for compliance.
- Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills.
- Training or experience in scientific, regulatory, or medical writing desirable.
- Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project); tools for process design, charting, and visual depiction; and systems for document management, publishing, communication, and learning management.
- Understanding of the fundamentals of electronic publishing of procedural documents. Qualifications (ie, preferred education, experience, attributes)
- A minimum of a BA or BS is required.
- A minimum 2-5 years experience in design and documentation (eg SOP's or equivalent documentation) of pharmaceutical business processes (eg safety, regulatory, and/or clinical). Desirable: training or experience in the development and delivery of training related to implementation of new processes and performance support.

SKILLS
Safety and Risk Management, Standard Operating Procedures (SOP's), Good Clinical Practices (GCP)
Synectics is an Equal Opportunity Employer.