ROLE SUMMARY

The Business Process Support Senior Specialist (BPSS) will be reporting to the Global Clinical Supply (GCS) Strategic Hubs (GSH) Team Lead, with a matrix reporting relationship to the Strategic Operations Management - Procedure and Process Design Team (SOM-PPDT) Lead. The GCS SOM-PPDT is a business-enabling function that assists with procedure and process design development and management to ensure alignment in support of current business operations and processes.

The BPSS role will serve as a subject matter expert (SME) to PPDT related to procedure reconstruction and process modeling activities. The BPSS provide business process support for GCS operations on projects relating to business process enhancement/modeling, program/protocol management and continuous improvement in the context of procedural documentation development and redesign (policies, standards, standard operating procedures (SOPs)), communications, training development, monitoring, data analysis and development, and other relevant supporting tools and documentation. This requires support in alternative global time zones.

• Collaboration with Functional Line Subject Matter Experts (SMEs): Work closely with Functional Line SMEs to develop, revise, refine, and implement procedural documents and corresponding process models and training materials where applicable.
• Facilitation of Procedure Redesign: Lead the redesign of procedural projects and provide project management according to established plans, engaging relevant SMEs and stakeholders throughout the process.
• Evaluation of Documentation: Continuously assess procedural documentation against evolving Pfizer and GCS requirements, audit/inspection/quality findings, business needs, industry standards, stakeholder feedback, and trends, making recommendations for changes as needed to ensure adherence to procedural requirements and other standards.
• Management of Queries and Deviations: Handle queries and deviations related to assigned policies/procedures and provide support for procedure revisions and restructuring as necessary.
• Development and Management of Process Portal Content: Assist in the development, implementation, and oversight of the GCS Process Model site content, ensuring the availability of accurate and complete procedural documentation for GCS operations. Manage queries and deviations from the organization related to assigned policies/SOPs, and support SOP revisions/reformatting/modeling.
• Process Mapping Support: Provide support for process mapping activities related to procedural updates and quality event investigations within GCS. Provide system support and enhancement to current systems related to development and maintenance of procedures, auxiliary documents and process models.
• Support for Assigned Projects: Aid in the design, delivery, and management of activities related to assigned projects, including GCS Process Model site enhancements, training design and development, and other strategic projects assigned by GSH Team Lead and SOM Lead.
• Act as SME for PPDT: Develop standards for procedure reconstruction and process modeling based on technical know-how and gained experienced with solicited advice from process SMEs with relevant experience to clinical supply chain business and processes. Serve as a SME and trainer for procedure and process mapping activities for the team.
• Project Management: Manage muti-faceted projects related to Process Modeling and Procedure Reconstruction by developing project plans, timelines, identifying customers/stakeholders and availability, compiling information/resources, and leading meetings to deliver every project on time and within scope.
• Global Collaboration: Attend periodic meetings with teams in alternative global time zones, highlighting the role's requirement for global collaboration and communication.

• Bachelor's degree (BA/BS) in technical writing/communication, computer science, scientific, supply chain, or business field, coupled with specific training in process modeling, design, analysis, and improvement methodologies.
• 5+ years of experience in process design and documentation of pharmaceutical business processes.
• Excellent technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing and reporting (PowerBI, Spotfire, etc.)
• Fluent in verbal and written English.
• Strong and effective verbal and written communication skills.
• Demonstrated organizational, project management, administrative, and technical skills.
• Demonstrated strength in analytical skills and attention to detail.
• Ability to prioritize and manage multiple complex projects and meet targeted deliverables and deadlines.
• Possess good business acumen.
• Ability to adapt to changing situations and work well under pressure.

• Previous experience in continuous improvement initiatives with ability to identify and implement process enhancements.
• Strong interpersonal skills with a demonstrated ability to manage stakeholders at different levels of technical and business roles, fostering effective communication and collaboration.
• Training or experience in safety, regulatory, medical, and/or clinical supply process training development, delivery, and/or implementation processes.
• Proficiency in tools for process design and mapping, reporting, and systems for document management, publishing, communication, and learning management.
• Understanding of the fundamentals of electronic publishing of procedural documents.
• Ability to adapt to changing situations and work well under pressure.
• Pharmaceutical industry experience preferred.
• In-depth understanding of pharmaceutical business processes and regulations, guidelines, and industry standards for compliance.
• Proficient and trained in using root cause analysis tools to drive quality investigations to appropriate closure, including remediations as required.
• Exposure to working in a GMP/GCP environment and with regulatory audit teams.