Posted 2 years ago in Biotech/Pharmaceutical
PWR7646 Process Documentation Designer Bridgewater, NJ, 1 Year
Position Purpose Collaborate 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 Medical organization worldwide.
• 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. Ensure processes are designed to achieve agreed objectives for quality, regulatory compliance, and operational effectiveness. Define appropriate performance standards (e.g. 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 project manager and/or act directly to establish and maintain project plans, with appropriate controls defined for key deliverables.
• Collaborate closely with procedural documentation developers and/or act directly to develop procedural documentation, facilitate review and approval, publish, and communicate.
• Collaborate closely with training developers. Contribute to training strategies and plans. 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 subject matter expert in regard to process design and change management.
Keep informed and up-to-date with respect to evolving relevant methods, technology, and standards related to process design and change management, both on site and in the industry. Make recommendations for improvement to methodology, infrastructure, and tools as appropriate.
• Contribute 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.
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.
• 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.
• In-depth understanding of pharmaceutical business processes (safety, regulatory and clinical) and regulations, guidelines and industry standards for compliance.
• Strong verbal and written communication skills.
• Strong interpersonal and relationship-building skills.
• Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills.
• Strong orientation to detail and ability to function independently as appropriate.
• Training or experience in scientific, regulatory, or medical writing desirable.
• 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.
• 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: (i.e., preferred education, experience, attributes):
• A minimum of a BA or BS is required.
• A minimum 2-5 years experience in design and documentation (e.g. Standard Operating Procedures or equivalent documentation) of pharmaceutical business processes (e.g. 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.
About Sigma Systems Inc.
Located in Marlborough, MA, Sigma Systems, Inc. is an award-winning IT Consulting and Staffing company with national presence. Over a successful 16 year existence, Sigma has received numerous awards including being one of Central Massachusetts. Top Growth Companies and being #24 in Inc's 500. Our success is a testament to the quality professionals working at the company.
With consultants working on projects in more than 23 states across the U.S., we have a network that affirms our strength. Sigma is a direct preferred vendor to Fortune 500 clients in the Finance, Insurance, Healthcare, Medical/Clinical, Pharma/Bio-Tech/Life Sciences, Manufacturing/Engineering, E-Commerce, Retail, Storage/Network Data Management, and Government Contracting industries.
From a Supplier Diversity standpoint, Sigma is a NEMSDC, MWBE, and DBE certified company. Our connections and relationships in the IT space help us provide our clients with top talent and a short turn-around on their unique, hard-to-fill mission critical positions. Sigma has the ability to augment its client' staff to meet the unique demands of their end-users.
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