Senior Associate, Vaccine Clinical Compliance

ROLE SUMMARY

This position is responsible for supporting the Compliance Head in managing the review and implementation of Pfizer Policies and Standard Operating Procedures (SOPs) to ensure compliance with regulatory requirements, maintain/improve quality, ensure inspection readiness related to the conduct of clinical studies, and management of clinical data for the global Vaccine Clinical Research and Development (VCRD) organization.  This includes Phase 0 through Phase 4 studies (post-marketing commitments and licensing studies). 

Role Responsibilities

• Ensure a robust quality culture and maintain processes to drive high standards of excellence and compliance
• Coordinate review of Pfizer Policies/SOPs by providing review and impacts to VCRD processes, and requesting Subject Matter Experts’ (SME) input
• Assist in the development of Vaccines Clinical-specific guidance documents to support SOP processes
• Assist in the development and implementation of appropriate SOP training curricula and ensuring training compliance in the Power to Learn (P2L) system
• Assist in preparation and support for managing inspections
• Help to track areas of compliance risks
• Interface with appropriate departments, functions, and SMEs regarding compliance-related programs, questions, and communications

Training Compliance Oversight:

• Aid in coordinating curriculum management and proactively identify roles within VCRD that are impacted by changes to ensure colleagues and contractors are assigned the appropriate training, including new hire training
• Identify unmet training needs and areas of opportunities
• Track training compliance through regular reporting/follow-up
• Monitor metrics and provide reports to management regarding training completion 
• Work with Operational Performance Strategies and other training resources to define needs/implement required training
• Conduct annual or periodic training for Vaccines colleagues as required (Biospecimen Management training, etc.)

Document Management/Inspection Support:

• Facilitate collection and review of new hires’ curriculum vitae; maintain monthly VCRD organizational charts
• Generate the monthly VCRD Study Master List
• Ensure required documents are always inspection-ready
• Assist in developing, implementing, and maintaining compliance and inspection readiness plans in collaboration with key partners via coordination, communication, documentation, and training
• Conduct regular reports of Trial Master File completeness; check ad-hoc reports as necessary to ensure 100% compliance at all times

SOPs/Processes:

• Continually ensure compliance with quality processes and procedural documentation, as required
• Maintain list of SMEs to assist in the development/revision and implementation of SOPs and/or Implementation Guidelines as they relate to VCRD 
• Help to develop implementation guidelines, task ownership matrices, and process maps for implementation of SOPs
• Plan and manage projects related to development and implementation of VCRD quality processes and procedural documentation

Quality/Audit Management:

• Evaluate Informed Consent Documents (ICDs) for permissible biospecimen research use language and coordinate completion of necessary form(s)
• Interface with Quality Assurance/Corporate Compliance, functional areas, investigational sites, labs, and vendors regarding corporate, quality, and process audits
• Help track areas of risk in quality, compliance, and inspection readiness. 
• Help analyze trends and assist in the development and implementation of corrective/preventive action plans and risk mitigation strategies within VCRD and with partner lines.

BASIC QUALIFICATIONS

Education:

• Bachelor of Arts/Bachelor of Science with 5+ years in quality assurance, pharmaceutical, regulatory, or health care fields
• Master of Arts/Master of Science with 3+ years in quality assurance, pharmaceutical, regulatory, or health care fields
• Quality certification (e.g., RQAP-GCP) or project management certification (e.g., PMP) desirable, but not required

PREFERRED QUALIFICATIONS

Experience:

• Proven experience in a compliance position required
• Strong knowledge of and experience with ICH, FDA, EMEA and/or GLP/GCP/GMPs, with an emphasis on clinical processes and GCP preferred
• Experience with regulatory inspections and audits preferred
• Project/process/facilitation management with demonstrated attention to detail
• Training design and development
• Savvy communication/interaction with senior stakeholders

Technical Attributes:

• Computer and systems skills: industry enterprise systems, MS Office applications, SharePoint sites, TEAMS, and a solid understanding and use of relational databases
• Change-agile, ability to multi-task and prioritize assignments, and work well in a team environment or independently in a matrixed organization with a minimal amount of supervision
• Strong communication (written and verbal facilitation and presentation skills) with an ability to respond with professionalism throughout all levels of the organization
• Ability to conduct deep data mining on occasion, as required 
• Take initiative to bring forward ideas for process improvements and more efficient operations
• Ensure accuracy of work and use judgment to determine best work methods in different situations
• Demonstrate collaboration and communication skills in a team environment, share knowledge, influence best-practices, and coordinate workflow
• Strong self-starter, independent, proactive, and self-motivated
• Ability to exhibit sound judgment in handling confidential information
• Diverse problem-solving skills and strong ability to think “outside-the-box”
• Know and model Pfizer Purpose Blueprint Values and Behaviors

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• On rare occasions, candidate may be required to call into meetings and discussions that may have participants from geographical locations around the world, at times that fall outside of the normal 8 am to 5 pm work hours.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control