Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Director, Regulatory Process And Information Compliance

Expired Job

Pfizer Collegeville , PA 19426

Posted 3 months ago

Role Summary

Oversee and direct compliance activities associated with the Regulatory process and associated tool(s), ensuring that Pfizer maintains compliance with both internal procedures and applicable regulations (e.g., Article 57, IDMP).

Through use of governance structures, quality controls and key performance indicators, oversee monitoring, reporting, quality assurance and inspection readiness of regulatory processes and information such as product and license data, ensuring alignment with GxP.

Represent WSR, PEH GRA, WRO with internal and external audits and inspections, and utilization of trends in findings to drive improvements.

Identify, understand, measure, communicate, and mitigate compliance risks related to Regulatory Product and License process, information and systems spanning regulatory affairs.

Sponsor and contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps, mitigate risks and improve compliance. Promote efficiencies within and consistencies between these processes, across all participating stakeholders.

Role Responsibilities

Working as a matrix with global delivery teams to govern the quality, delivery and compliance associated with regulatory processes, and product and license information.

Key Accountabilities

  • Overall accountability for ensuring compliance of in scope regulatory processes.

  • Sponsorship and leadership of cross-disciplinary governance forums.

  • May serve as representative on Project Teams and/or Pfizer project governance bodies & steering committees to achieve consensus for specific strategies.

  • Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum processes in support of products throughout the development and commercial lifecycle of the drug.

  • Govern implementation of global policies and strategies to meet evolving business needs

  • Govern implementation of technological solutions to the varying aspects of regulatory compliance.

  • Demonstrated ability to effectively lead cross-functional teams and to autonomously influence business decisions where direct reporting line relationships do not exist.

  • Collaborate with peers at other pharmaceuticals and global regulatory authorities as appropriate to lead direction and development of regulations and guidance.

  • Support peers in process ownership for the regulatory processes, monitoring adherence and ongoing process adjustments as needed.

  • Ensure appropriate processes exist for ongoing assessment and maintenance of procedures and processes to identify procedural and compliance gaps; establish and monitor remediation plans

  • Oversee identification and assignment of necessary training programs, establishing and monitoring adherence to curricula

  • Lead and/or sponsor cross-functional and strategic initiatives, novel concepts and solutions to enhance and improve conformance.

Basic Qualifications

  • Bachelor's degree required in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.

  • 10+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 8+ years pharmaceutical regulatory experience.

  • 6+ years' matrix leadership, including experience providing guidance and coaching for others globally, managing resource capacity and prioritizing workload.

  • Experienced in exercising independence in judgment and decision-making principles to influence regulatory & business strategy and process, guiding complex projects with broad impact and balancing risk with organizational flexibility & business needs

  • Experience leading collaborations within & across divisions, working with other scientific & technical leaders to drive projects and implement business initiatives.

  • Capable of developing & advocating regulatory and quality policies.

  • Mature demeanor to effectively collaborate & guide under accelerated timelines & volatile business pressure not inclined toward reactionary or hasty judgment.

  • High level of knowledge of the drug development process and significant experience operating within GxPs.

  • Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

  • Knowledge of the Regulatory business as it relates to drug development and license maintenance

  • Strong Experience with regulatory data and submissions, process development and GxP

  • Strong understanding of Regulatory environment including CTD content/structure.

  • Detailed Understanding of accurate regulatory product and license information Data management throughout lifecycle and its impact on downstream processes

  • Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for assigned projects, mentor and share experience with colleagues.

  • Demonstrated sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory discipline and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.

  • Excellent English writing and oral presentation skills is mandatory.

  • Computer literacy with Microsoft Office Suite and Documentum-based applications

  • Ability to influence without authority

Preferred Qualifications

  • Master's degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.

  • Experience engaging in the external regulatory & pharmaceutical environment is preferred.

  • Knowledge of partnering organizations and systems is desired.

  • Lean and/or SixSigma experience helpful.

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: September 28, 2018

  • Additional Location Information: New York, NY; Peapack, NJ; Collegeville, PA; Lake Forest, IL; Groton, CT.

  • 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.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Information Manager

Pfizer

Posted 7 days ago

VIEW JOBS 12/10/2018 12:00:00 AM 2019-03-10T00:00 ROLE SUMMARY * Senior Information Manager is expected to support reporting needs of IM stakeholders and proactively develop solutions to data challenges. * Individual filling the position is responsible for leading medium to large size projects to elicit new data integration and reporting requirements for our regulatory systems and taking those requirements through the software development lifecycle in partnership with Business Technology and key business stakeholders. ROLE RESPONSIBILITIES * Develop and maintain suite of reporting solutions to serve the Regulatory organization and supporting business lines * Support integration of regulatory solutions into business processes * Provide expert data analysis support to key stakeholders for regulatory data * Liaise with business stakeholders and technical groups to define or gather data integration, automation, or reporting requirements and execution strategy * Contribute to and lead quality oriented projects intended to ensure high quality data in our regulatory tracking systems * Lead development of solutions to customer data issues and contribute to written materials that communicate solutions and/or options to relevant stakeholders * Lead continuous improvement projects to simplify and improve system use and system management, including opportunities for data automation and system integrations * Develop and execute ad hoc or standard queries to extract data from supported systems and follow established procedures to validate queries/results in support of business requirements * Define data standards and quality measures in partnership with supporting business lines * Develop monitoring reports to ensure proper system usage and data standards alignment BASIC QUALIFICATIONS * Bachelor's Degree in life sciences, information management, library science, information technology, computer science, business administration or related discipline * 7+ years' experience in Pharmaceutical industry or in a data analysis and reporting role * Experience with data analysis and reporting techniques (e.g. SQL, PL/SQL, Brio, etc.) and business intelligence technologies (e.g. Spotfire, Tableau, Alteryx) * Strong analytical and critical thinker with the ability to solve issues and communicate findings * 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. * Strong demonstrated project management and organizational skills * Experience with systems management and maintenance including document management systems, databases, business process management and electronic workflow/routing tools, regulatory submission and tracking systems * Technical aptitude for learning new applications and data models PREFERRED QUALIFICATIONS * Master's Degree in life sciences, information management, library science, information technology, computer science, business administration or related discipline * 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. Pfizer Collegeville PA

Director, Regulatory Process And Information Compliance

Expired Job

Pfizer