Posted in Other about 2 hours ago.
Type: Full time
This position will be responsible for managing operational Quality projects with a focus on Clinical Quality Regulatory tasks. There are many compliance tasks that will be driven independently by the individual as required within the Quality, Informatics, and Data Operations (QIDO) team. Primary support will be for the VCRD (Vaccine Clinical R&D) organization, but support will also span other areas in VRD (Vaccine R&D) including but not limited to CIHO (Clinical Immunology High-throughput Organization), CD&RWEA (Clinical Diagnostics & Real World Evidence Assays), VRD early research, and external partners. The candidate will work with the leadership across various partner line functions (directly working with Sr VPs, VPs, and Franchise Heads) within VRD and broader PRD: Clinical Ops, Vaccine Development Management, Quality Assurance, Statistics, VRD labs, and across PRD (Pfizer R&D) to provide leadership, direction, and operational support that ensure adherence to regulatory requirements, Pfizer's corporate policies, and procedures governing the conduct within the unit.
The compliance lead shares the responsibility for compliance and inspection readiness with senior management and with key partner lines. This work includes Phase 0 through Phase 4 studies (post-marketing commitments and licensing studies). The major focus is compliance of the unit related to the conduct of clinical studies and the management of clinical data and especially any large-scale projects around innovating those functions. Process refinement and optimization is a critical component of the role to ensure the unit is working efficiently (with use of technology) and in compliance with regulatory standards. The individual must be open to change and collaboration, especially across the enterprise functions that manage Regulatory Quality and Compliance, with BPOs (Business Process Owners) for Clinical and Medical Controlled Documents (CMCDs) and SOPs, and with external partners/vendors/contract labs.
Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare .
ROLE RESPONSIBILITIES:
BASIC QUALIFICATIONS:
PREFERRED QUALIFICATIONS:
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Other Job Details:
The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Regulatory Affairs
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