PPDM Process Management Lead
New York, NY
- Accountable to manage and implement the quality oversight plan for the process portal content containing ~ 42,000 informational objects pertaining to process quality standards, global and local country & functional area procedural documentation (policies, SOPs and associated documents) and other related information to ensure ongoing availability of complete and accurate process and procedural document content for clinical, medical, safety, regulatory and enterprise quality management system processes. It is essential that this content remain accurate and up to date as it is included in Pharmacovigilance regulatory submissions.
- Function as a key subject matter expert in the process framework, process architecture, process engineer and modeling or standards and conventions. Advise, coach and train CMCD authors, Document Specialists, Process Owners, and other process experts enabling accurate and efficient execution of business processes and use of business applications.
- Interpret business challenges and best practices to deliver strategic recommendations regarding process portal design and implementation; propose options to resolve complex problems and make decisions within business line.
- Lead/support development and ongoing evaluation of departmental processes, providing advice on process enhancements and continuous improvement.
- Manage to resolution any questions about or issues arising from the Process portal, process modeling or standards and conventions.
- Serve as the subject matter expert and liaise with Information Management partners for user acceptance testing of new versions of the underlying portal management software or resolution of technical issues.
- Oversee support staff and contingent workers in daily activities related to the process portal, including training on process enhancements, and providing feedback and remediation.
- Independently manage the S&T query assistant website business process and content of over 1200 questions/answers.
- Lead special projects related to process portal as requested by supervisor.
- Independently prepare monthly/biannual/annual metrics, identify and evaluate metric trends; lead the review, endorsement, issue follow-up/resolution, and communication of metrics.
Process Evaluation/Integration & Acquisition
- Facilitate/contribute to the evaluation of regulations, acquired procedures, etc. into Pfizer processes ensuring proper compliance, documentation, and implementation plans.
Audit/Inspection Readiness & Support
- Facilitate/oversee the accuracy and completeness of process portal data by evaluating queries, performing data reviews, and reconciling findings to ensure accurate reporting.
- Contribute to compliance and inspection/audit readiness strategies and plans.
- Participate in regulatory inspections, and other internal audits by, interpreting the requests, quality control checking and providing information, and responding to findings.
- A scientific or technical degree is preferred.
- Business degree and/or coursework with specific training in the following is preferred:
- process modeling, design, analysis and improvement methodologies and tools
- data analytics, including data connections, query design, chart/visual development and tools
In general, candidates for this job would have the following levels of education/experience:
- BS and over 7 years; MS and over 5 years,
- Experience in process design and modeling methods, demonstrated ability to design effective processes.
- Demonstrated experience in project management and implementation techniques.
- Previous continuous improvement experience considered a plus.
- A strong working knowledge and understanding of drug development processes, database structures, relational database management software, and data analysis tools.
- Strong interpersonal skills with a demonstrated ability to interact and influence with many levels of technical and business staff. Excellent analytical and organizational skills are required. The candidate must also possess very good communication skills (both written and verbal).
Relocation assistance may be available based on business needs and/or eligibility.
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.
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.