IRT Senior Support Specialist

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 Senior Support Specialist role sits within the IGOT Support function and will be responsible for maintaining the day to day training scheduling and feedback collection, leading support team process updates and change management, management of support team system testing, and lead QTS investigations.   This role is intended to support the implementation of continuous improvement initiatives through process development and team training to ensure the patient focused delivery of customer support services in support of Pfizer’s evolving portfolio.

For this position candidates will need to have excellent process knowledge, as well as very good verbal and written skills to facilitate group trainings, 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

• Create and maintain colleague training schedule and maintenance of training materials for the help desk support team globally to ensure 24/7/365 coverage.
• Consult on the design of IRT systems to provide help desk insight to proactively minimize the number of helpdesk tickets post study go live and serve as a resource to support team members.
• Provide support team with guidance on and maintain support schedule for testing of Impala 2.0 study builds to ensure system is conducive to support activities
• Review, assess, and appropriately update IGOT Support SOP’s, training, and guidance documents associated with IRT system processes
• Identify, initiate and complete QTS records and related corrective and preventative action plans to ensure appropriate documentation and resolution of issues. 
• Serve as a resource for colleagues that provide first line application support to customers using the Pfizer Internal IRT Systems.
• Ensure that when communicating with blinded customers, that the blind is maintained and provides break blind support to blinded site and study team members.
• Act as primary or backup support team member for critical fast moving complex studies.

Qualifications

• Minimum of 9+ years of biopharma industry experience with IRT, clinical supply, and/or business analysis required
• BA/BS, in computer science, life science, or business field desired.
• Understanding of the nature of clinical data and concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
• Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams
• Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus
• Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required
• Comfortable working with a global team, partners and customers in a change agile environment

Nice-to-Have

• Master's degree
• Advanced training in project management, supply chain management, scientific or clinical disciplines, business administration and/or people development

  
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
 

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
• Experience with business analysis and/or project management tools a plus (ex. MS Project, MS Visio, HP Quality Center, or any other requirements visualization and analysis tools)
• Ability to represent IRT function in a high-pressure environment (e.g., during regulatory inspections).

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Provide leadership oversight during  weekend and holiday coverage to ensure 24/7/365 support coverage of the Pfizer Internal IRT Systems as appropriate. 

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.

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