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Compliance & Oversight Lead


Groton, CT
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Job Details

This position leads the development of contributions to labeling policies and processes and champions the execution of process and system changes throughout WSR functional lines/roles impacted. This position drives inspection readiness by defining projects and actions necessary and working with stakeholders within WSR to execute inspection readiness activities. This position is responsible for monitoring and analyzing labeling/regulatory compliance, performance and business process. This position is also accountable for identifying end to end process trends, opportunities for improvement, formulating projects and specifics plans necessary for corrective and preventive actions of the designated business needs. This position leads teams and/or projects, from design through including implementation/execution and closure.

Drives the overall business process, oversight, and compliance by:

+ Compiling data from various source, generating, analyzing and supplying GLM dashboard, various business scorecards and compliance graphs, PSMF report etc. Crafting key messages to accompany these various reporting activities.

+ Supporting BPO framework and delivering on core BPO related responsibilities

+ Leading process development via translating business requirements into current and future business process.

+ Creating efficiencies with technologies utilized and identifying new technologies that enable better business efficiencies, e.g. batching calculator, PRL maintenance,

+ Authoring and contributing to Labeling policies and processes via CMCDs, etc.

+ Leading projects from conception through execution.

Act as primary business contact (SME) for labeling system development. Work across all necessary stakeholders within and outside WSR to align business needs and expectations to technologies and longer term technology roadmaps.

+ Contribute to designing and building system user requirements, reviewing configuration specifications, system record investigation/resolution etc.

+ Contribute as a member of necessary system change control boards and impact resolution team

+ Chair Labeling SME-IM Governance Forums

+ Lead business side discussions regarding specific projects and priorities

Oversee End-to-End Labeling process, data quality and compliance by:

+ Performing complex process and quality monitoring; design and document agreed upon business plan and schedules

+ Creating and maintaining required labeling/regulatory quality management plan

+ Participate and/or lead CAPAs, QEs and audits and inspections for both above country and regional issues in department scope

+ Providing oversight of monitoring processes including submission timelines delays/rationales, content inconsistencies, etc.

+ Problem solving issues with data integrity against CMCDs, supporting documents and technical expectations.

+ Recommend & lead holistic, end to end quality analysis across multiple systems and processes

Drive Continuous Improvement and Efficiency Efforts by:

+ Using labeling/regulatory systems to analyze data, identify improvement opportunities and propose/lead changes.

+ Investigate and design new and innovative ways to solve business problems, improve processes and drive efficiencies.

+ Acting as SME for various divisional initiatives involving labeling and regulatory strategy process.

+ Serving as business leader of labeling/regulatory CI projects aimed to increase efficiencies, simplify, improve quality, and/or reduce cost.

+ Keep informed of industry norms and evaluate against and for Pfizer best practices

+ Influence industry labeling best practice via industry forums, conferences, e.g. LabelNet



+ Bachelor's Degree required. Advanced academic qualification/degree desired


+ 8+ years' experience in global/multi-national pharmaceutical environment, including 2 years direct experience either in Labeling or Regulatory Affairs role required.

+ Experience with Business Analytics required.

+ Experience participating in audits and preparing for inspections or other quality related background desirable.

+ Experience with interacting autonomously with leaders and working in a matrix team environment a must.

+ Experience in interpreting and applying global and local regulatory guidance around labeling/regulatory and associated supportive documentation desirable.

+ Experience in labeling and/or artwork processes preferred

+ Demonstrated track record of delivery to time and quality

**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.

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: April 18, 2018**

+ Additional Location Information: Collegeville, PA; Peapack, NJ; Groton, CT; New York Headquarters, NY.

+ Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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