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Director, Regulatory Submissio...

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Job Summary

Company
Pfizer
Location
Groton, CT
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4903_4707945

Director, Regulatory Submissions & Statistical Programming

About the Job

This is an exciting opportunity to further shape the future global submission strategies for clinical trial data within Pfizer.

This new position will develop and advance the programming strategies, processes and key deliverables for electronic submissions to global regulatory agencies (including the FDA, PMDA and EMA).  This role will research the industry and regulatory landscape, challenging the status quo and build long-term global partnerships within key functional groups within Pfizer and across the industry.  This role will be critical to the continued success of high quality submission deliverables to enable the fast delivery of new drug treatments to patients.

In this role, one must utilize extensive experience of electronic submissions in variety of data standards and demonstrate skills in analysis, design, and strategic planning to enable ideas to emerge into continuous improvement opportunities for implementation within our enterprise.

Responsibilities

  • Lead the review of the long term strategy for electronic submissions in support of Pfizer Global Biometrics and Data Management (GBDM)
  • Be the centralized point of reference for electronic submissions across the organization and be the lead business partner advisor on regulatory authority reviewer tools and future initiatives
  • Develop solutions to improve the submission processes and timelines with respect to high quality, relevant, review-ready components.
  • Represent the business and provide guidance to electronic submission initiatives across the industry and regulatory landscape. 
  • Provide thought leadership on innovation: Identify new opportunities, technologies, risks, and trends. Stay current with leading edge systems, methods, and best practices.
  • Identify new strategic approaches to accelerate innovation. Seek exposure to wide variety of process and technology problems and their solutions to drive the adoption of best practices
  • Lead and coach internal teams and business partners leveraging proven expertise and experience in the submission space
  • Review current and future regulatory review tools and required supporting documents to ensure Pfizer is seen as the leader in meeting regulatory and reviewer needs.

Basic Requirements

  • Masters or MBA degree required, preferably in Information Technology, Data Science, Computer Science or equivalent combination of experience, education, and/or specialized training
  • 5-10 years of  professional experience leading process design and continuous improvement initiatives
  • 10 years of regulatory submission experience, including extensive experience of regulatory review tools (including recent experience with Pinnacle 21)
  • 5-10 years of experience of driving process and system improvements and extensive knowledge of CDISC data standards and regulatory data requirements. 
  • Expert Communication skills: with an established network of contacts across the industry

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.

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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