Pfizer Data Standards and Quality Lead in New York, New York

Individuals filling the position listed are responsible for working with business process owners to establish, execute and monitor sound quality plans, metrics and measures, and remediation processes around the Regulatory Solutions portfolio of systems

Role Responsibilities

  • Participate in and lead medium to large projects focused on system quality intent to ensure high quality data in our regulatory systems

  • Deliver process and system solutions to address customer needs

  • Develop materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions.

  • Coordinate with regulatory business including - safety, regulatory, operations and technical groups to define or gather business requirements for data oversight

  • Coordinate with regulatory business including - safety, regulatory, operations and technical groups to make decisions on information quality standards

  • Establish and support continuous improvement projects to simplify and improve system use, system management and data quality

  • Establish, execute and monitor data quality & standards measurements across regulatory solutions

  • Define system training program for regulatory solutions and collaborate with business lines to ensure a consistent approach with business process-specific training.

  • Deliver strong data analysis support ongoing to key stakeholders for regulatory data

Qualifications

  • Bachelor's Degree in life sciences, information management or computer science related discipline

  • Demonstrated, in depth knowledge of Pharmaceutical drug development environment and regulations.

  • Demonstrated customer relationship skills and capabilities and collaboration on teams.

  • Demonstrated ability to perform in a cross-functional environment.

  • Strong verbal, written communication and presentation skills.

  • Ability to interact in a professional manner and build strong collaborative relationships with internal Pfizer teams.

  • Ability to interface with international colleagues, understand the "big picture" in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/region

  • Strong demonstrated project management and organizational skills

  • Minimum of 10-15 years business processes in the pharmaceutical industry, including an understanding of the drug development process.

  • Experience with systems management and maintenance including document management systems, databases, business process management and electronic workflow/routing tools, regulatory submission and tracking systems.

  • Knowledge of application system management and change control processes, application validation and implementation in a GxP environment

  • Knowledge of Pharmaceutical metadata and standards

  • Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, Brio, MS_Access)

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.

Additional Offer Details:

Grade: 11

Additional Location: Peapack, NJ

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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