IRT Implementation Group 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 Implementation Group Lead is a new role that will serve as the single point of accountability for the management of IRT processes, guidance documentation, and systems/tools governing these documents. Outside of general management and oversight, this role will own the strategy and execution for: training of new IRT Implementation colleagues, re-training as required, and systems/tools used for Pfizer’s internal IRT systems. The implementation of this new role within IGOT is intended to strengthen process and training management and streamline delivery of process and training content to increase agility.

The IRT Implementation Group Lead will serve as a primary escalation interface for IGOT regarding the overall management of Implementation process and training execution to ensure continuity of process updates, rollout of changes, and the training of new Implementation colleagues. This role will report to the IRT Engagement Group Lead within IGOT.

For this position you will need to have strong people, organizational communication, and training management skills to effectively ensure the IGOT Implementation team has an efficient and robust new hire training plan, process updates communicated as needed, and all process and training documentation are accessible easily by the team.

ROLE RESPONSIBILITIES

• Provide management and oversight of IGOT’s Implementation function for Pfizer’s internal IRT systems.
• Point of escalation and management interface for IGOT Group Leads, Technical Leads, IRT Leads, and Design Specialists to management of processes, guidance, and training.
• Partner closely with other IGOT’s Leads for issue escalations training metrics, and process optimization.
• Ensure IRT processes are compliant with GCP & GMP guidelines and principles, 21CFR Part 11, and applicable regulations.
• Lead quality/compliance investigations and issue resolution.
• Lead and/or contribute to cross-functional initiatives that drive increased compliance, quality, and efficiency across GCS and GPD.
• Review, propose, and implement content and training solutions enabling more efficient/effective training and process/guidance management (i.e. training systems).
• Maintain strong understanding of the nature of clinical data.

QUALIFICATIONS

• B.S./B.A. degree is required, with 11+ years in biopharma industry.
• A MS or MBA in business, information systems, supply chain desired.
• Experience managing, organizing, and leading system training efforts (use of training tools a plus).
• Advanced knowledge of IRT systems, scientific, technical, or clinical disciplines, and/or people development desired.
• 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, AIM, or Lean Six Sigma Green Belt/Black Belt a plus.
• Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram.
• Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required.
• Seamlessly work with a global team, partners, and customers in a change agile environment.
• People management experience desired.

PHYSICAL/MENTAL REQUIREMENTS

Core Competencies include:

• Dealing with ambiguity
• Peer and customer relationships
• Acts decisively
• Seizes accountability
• Analytical capability to solve problems

  
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.

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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