IRT Design Lead

The IRT Global Oversight Team (IGOT) is a well-established high performing team within Pfizer's Global Clinical Supply unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.

ROLE SUMMARY

The IRT Design Lead is a role within the Design team that is responsible for designing, configuring, and verifying study builds in Pfizer’s internal IRT systems. The implementation of this dedicated function within IGOT is intended to ensure the delivery of high quality IRT systems through focused system expertise while improving velocity in support of Pfizer’s evolving portfolio.

The IRT Design Lead will be assigned at the requirements elicitation stage and will partner closely with IGOT’s IRT Leads, IGOT’s Support Team, Pfizer Digital (Business Technology), and Quality Assurance to ensure system requirements, standards, design, and validation deliverables are consistently employed across programs while meeting portfolio timelines and demands.

The IRT Design Lead will also partner with IGOT management on quality investigations, CAPA commitments, continuous improvements, SOP review and revision activities, and other limited duration teams where appropriate.

For this position candidates will need to have excellent technical and analytical thinking skills, be a creative problem solver, and have a strong commitment to quality to successfully deliver optimal IRT systems across a diverse and dynamic portfolio.

ROLE RESPONSIBILITIES

• Design, configure and test internal IRT systems using requirements documentation supplied by IRT Leads while ensuring configuration standards are incorporated into system builds
• Manage the delivery plan for configuration and testing activities and communicate risks
• Partner with the IRT Lead to identify testing strategy and with Pfizer Digital to develop and deploy study specific logic (SSL) where needed to support complex study designs
• Create supportive IRT documents and provide a system demo to the study team as part of system acceptance process
• Write and approve user acceptance testing (UAT) and summaries for assigned studies where UAT methodology is employed; track defects and support resolution
• Perform quality checks (QC) for each study IRT configuration
• Support creation and maintenance of IRT standards for system configuration and UAT/QC processes and provide technical expertise and issue resolution for configuration, UAT and/or QC processes
• Support quality investigations and continuous improvement projects and provide input into SOPs and process development

QUALIFICATIONS

• BA/BS, in computer science, scientific, or business field desired in biopharma industry
• Minimum 5+ years of experience with IRT systems required; IRT system configuration and validation experience preferred
• Understanding of the nature of clinical data, with particular regard to the concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
• Experience with the use of Microsoft compare tools such as Word Compare and Excel Exact Match
• Experience with Agile development methodology preferred including use of storyboards and associated test cases
• Exposure to working in a GMP / GCP environment and with regulatory audit teams
• Strong English language, written and verbal communication desired
• Comfortable working with a global team, partners and customers in a change agile environment

PHYSICAL/MENTAL REQUIREMENTS

• Database query, business analysis and technical writing skills a plus
• Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram desired

Work Location Assignment:Flexible

Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.