ROLE SUMMARY As part of the C linical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Business Process Lead is accountable for ensuring that processes are sufficiently robust to ensure inspection readiness is a routine part of the daily work. The Business Process Lead ensures processes are kept current, ensuring that CDIS is inspection and audit prepared. The Business Process Lead is also responsible for ensuring continuous improvement that results in innovative and industry leading processes at Pfizer. ROLE RESPONSIBILITIES Reporting to the Director of Process and Development the Business Process Lead will leverage their technical knowledge base and leadership abilities to deliver the responsibilities and services that include CDIS Inspection and Audit Readiness and business process creation. Acts as bu siness p rocess lead for clinical data sciences SOPs as needed and as a point of contact for creation, maintenance/updates, and interactions between internal and external partners, as well as when needed acting as a decision maker for selected CDS processes and related systems. Monitors and provides process oversight to ensure on an ongoing basis the quality of data deliverables produced by functional lines and CDS vendors is consistent and meets the highest integrity standards Works with the Process Oversight Board as B PO to drive data quality improvement, identifying opportunities to improve processes and controls in support of data integrity and submissions quality, and working to ensure quality and continuous improvement practices are fully integrated with the appropriate functional lines. Ensures the development and execution of CAPA commitments from inspection and audit findings. Maintains an active awareness of the technological and regulatory landscape both within and outside of Pfizer that impacts on CDS processes Participates with functional leadership to develop robust performance metrics that are intended to both evaluate data health, data compliance and to ensure correct execution of CDS tasks to standards of quality and inspection readiness Drives the development of forums that facilitate the sharing of best practices and the development of knowledge Within functional leadership, ensures CDS roles have appropriate skill development content in place Establishes strong partnerships with TA category groups, department leadership and other functions to advance asset or indication goals Works with CDIS leadership to ensure work carried out by or on behalf of CDIS is in accordance with applicable SOP’s and working practices. Helps develop a strong talent base and preparing for long-term development needs, via mentoring or matrix management QUALIFICATIONS Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred. At least 15 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency with at least 5 years being the development and implementation of clinical trial processes with an emphasis on data management. Process development experience desired Data Management and clinical trials expertise with a thorough understanding of the processes associated with clinical drug development and data analysis operations for the reporting of clinical trials and global regulatory submissions. Thorough understanding of regulatory requirements and relevant data standards. CDISC knowledge and experience are preferable. Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills Sound knowledge and experience working across international boundaries and cultures. PHYSICAL/MENTAL REQUIREMENTS Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc. NON- STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Ability to travel approximately 10 to 20%. Work Location Assignment: Hybrid Purpose Breakthroughs that change patients' lives At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Medical