Process and Procedural Document Specialist, Associate Director, Senior Manager -
Parexel, Poland, NY, United States
Overview
Demonstrated process development expertise.
You will be responsible to lead the development and revision of global processes and related procedural documentation (policies, standard operating procedures (SOPs), Work Instructions, Forms/Templates, and supporting documentation) servicing over 10,000 colleagues across the company’s clinical, medical, safety, regulatory, and quality management organizations. This is accomplished by applying process management skills, understanding the framework architecture, and quality standards that accommodate all key process knowledge dimensions (e.g., process roles and responsibilities, regulatory and quality requirements, performance measures and metrics).
Job Responsibilities
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 in 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.
Apply knowledge and understanding of global regulations in a GCP environment and produce processes and related documentation that meets regulatory requirements, supports corporate compliance, is inspection‑ready, and is designed with operational effectiveness in mind, including measurable controls where applicable.
Identify 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 serving as 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.
Organizational Relationships Clinical development and operations, safety, regulatory strategy and operations, medical and quality management organizations, and business process owners.
Qualifications / Skills
A minimum of a BA or BS is required; an advanced degree in a relevant field is desirable. Degree or professional certification in process design or change management, or equivalent experience.
A minimum of 5-8 years of experience in design and documentation of pharmaceutical business processes (safety, regulatory, medical, and/or clinical).
A minimum of 5 years of experience leading the development and revision of global processes and related procedural documentation (policies, SOPs).
Strong experience in team management and in the document management model, quality management system, and quality standards.
Demonstrated process development expertise.
Strong GCP experience.
Ability to manage multi‑phase moderately complex projects with multiple contributors/collaborators, facilitate cross‑functional global or enterprise teams, optimize subject matter involvement, and interact 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 Pfizer values and effectively implementing 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.
#J-18808-Ljbffr
You will be responsible to lead the development and revision of global processes and related procedural documentation (policies, standard operating procedures (SOPs), Work Instructions, Forms/Templates, and supporting documentation) servicing over 10,000 colleagues across the company’s clinical, medical, safety, regulatory, and quality management organizations. This is accomplished by applying process management skills, understanding the framework architecture, and quality standards that accommodate all key process knowledge dimensions (e.g., process roles and responsibilities, regulatory and quality requirements, performance measures and metrics).
Job Responsibilities
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 in 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.
Apply knowledge and understanding of global regulations in a GCP environment and produce processes and related documentation that meets regulatory requirements, supports corporate compliance, is inspection‑ready, and is designed with operational effectiveness in mind, including measurable controls where applicable.
Identify 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 serving as 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.
Organizational Relationships Clinical development and operations, safety, regulatory strategy and operations, medical and quality management organizations, and business process owners.
Qualifications / Skills
A minimum of a BA or BS is required; an advanced degree in a relevant field is desirable. Degree or professional certification in process design or change management, or equivalent experience.
A minimum of 5-8 years of experience in design and documentation of pharmaceutical business processes (safety, regulatory, medical, and/or clinical).
A minimum of 5 years of experience leading the development and revision of global processes and related procedural documentation (policies, SOPs).
Strong experience in team management and in the document management model, quality management system, and quality standards.
Demonstrated process development expertise.
Strong GCP experience.
Ability to manage multi‑phase moderately complex projects with multiple contributors/collaborators, facilitate cross‑functional global or enterprise teams, optimize subject matter involvement, and interact 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 Pfizer values and effectively implementing 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.
#J-18808-Ljbffr