Process Documentation Designer

RESPONSIBILITIES

- Collaborates with colleagues, customers, and stakeholders across the organization 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 organization worldwide.
- Plays a lead role with minimal/moderate assistance in business process analysis and design leading to development of new process standards.
- Follows outcomes-driven design principles.
- Ensures processes are designed according to agreed policy and business requirements.
- Ensures processes are designed to achieve agreed objectives for quality, regulatory compliance, and operational effectiveness.
- Defines appropriate performance standards (eg metrics).
- Ensures 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.
- Collaborates closely with project manager and/or acts directly to establish and maintain project plans, with appropriate controls defined for key deliverables.
- Collaborates closely with procedural documentation developers and/or acts directly to develop procedural documentation, facilitate review and approval, publish, and communicate.
- Collaborates closely with training developers.
- Contributes to training strategies and plans.
- Develops recommendations for training programs and performance support materials; develop materials as appropriate.
- Contributes to compliance and inspection readiness strategies and plans.
- Serves as a subject matter expert in regard to process design and change management.
- Keeps informed and up-to-date with respect to evolving relevant methods, technology, and standards related to process design and change management, both at the company and in the industry.
- Makes recommendations for improvement to methodology, infrastructure, and tools as appropriate.
- Contributes to the continual evaluation of procedural documentation against evolving industry/regulatory requirements and expectations, business needs, and client feedback and trends, making recommendations for changes when necessary.

QUALIFICATIONS

- 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.
- Demonstrated ability to manage multi-phased projects with multiple contributors/collaborators, facilitate cross-functional teams, optimize subject matter expert involvement, and interact at all levels of an organization critical for success in this role.
- In-depth understanding of pharmaceutical business processes (safety, regulatory and clinical) and regulations, guidelines and industry standards for compliance.
- Strong orientation to detail and ability to function independently as appropriate.
- Ability to work effectively and contribute proactively in a team-based environment as well as in partnership with colleagues, customers, and stakeholders.
- Ability to lead by example and effectively implement strategies through influence and persuasion.
- Demonstrated ability to adapt to changing situations and work well under pressure.
- Understanding of the fundamentals of electronic publishing of procedural documents.

SKILLS

- Strong verbal and written communication skills required, as well as strong interpersonal and relationship-building skills.
- Must have strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills.
- 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 required.
- Must have 1-3 years of experience using MS Visio, MS Excel, and MS Outlook.
- A minimum of a BA or BS is required.
- A minimum 2-5 years experience in design and documentation (eg Standard Operating Procedures or equivalent documentation) of pharmaceutical business processes (eg safety, regulatory, and/or clinical) required.
- Desirable: training or experience in the development and delivery of training related to implementation of new processes and performance support.
- Training or experience in scientific, regulatory, or medical writing desirable.

Synectics is an Equal Opportunity Employer.