Primary Activities Include
- Partner closely with Pfizer study teams in clinical, medical, legal, statistics and external business partners to ensure registrations and results postings adhere to internal policy and meet the requirements of public registry websites.
- Conduct quality reviews of disclosure deliverables and assist in gathering metrics for drug programs within their remit. They will also be responsible for operational execution, oversight, and compliance for all processes related to supporting internal and external data sharing commitments.
- Partner closely with Worldwide Medical & Safety Integrated Medical Operations Services members, colleagues in Global Biometrics & Data Management, Information Management, legal, policy, and communications, as well as external researchers.
- Ensure that the review, approval, and fulfillment of research requests for clinical trial data adhere to Pfizer policy and standards.
- Serves as a point of contact for internal & external clinical trial data requests – ability to review and triage requests for completeness and perform appropriate follow-up with external and internal stakeholders.
- Manages tracking status of all clinical trial data requests and proactively identifies requests that are at risk for delays in dissemination of data – works with internal and external stakeholders to remediate and resolve. Provides detailed metrics and other information related to data requests.
- Contributes to shaping Pfizer’s policies on Data Sharing & Disclosure and works with appropriate stakeholders to gather information to help formulate the policy and serves as Subject Matter Expert (SME) to communicate Pfizer polices to internal and external audiences.
- Tracks project performance, specifically to analyze the successful completion of short- and long-term goals.
- Meets budgetary objectives and adjusts to project constraints based on financial analysis.
- Leads cross-functional communication between project teams and external vendors and Interfaces and coordinate with outside vendors.
- Applies business expertise and project management excellence to the achievement of program deliverables and use of performance metrics that measure and improve operational processes.
Qualifications
- MBA, MS/BS in a relevant discipline preferred.
- 5-7 years working in the pharmaceutical industry in a project management capacity.
- Candidate should have strong technical skills including (at a minimum)
- Expertise in Microsoft Office applications (Excel / PowerPoint)
- Strong track record for delivery
- Experience with drug discovery and development in a global matrix organization.
- Detailed knowledge of clinical trial and regulatory operations processes, data and supporting systems and tools.
- Excellent communication, organizational, and leadership skills
- Detailed knowledge of product development processes such as Agile, and a strong understanding of clinical development
- Experience with Electronic Medical Record systems, coding standards i.e., HL7, CDISC, FHIR, and data aggregation tools.
- Strong verbal and written communication skills. Effective presentation and facilitation skills.
- Able to work and collaborate effectively as a trusted partner with stakeholders.
- Conversant with the long-term strategy of the business and is able to leverage this in order to prioritize activities and answer key business questions.
- High competency in disassembling complex problems, developing pragmatic solutions and providing guidance based on analytical output.
- Seeks quality information and provides analyses and recommendations supported by facts. Able to effectively visualize patterns to identify KPI’s.
- Contributes to a learning environment by sharing knowledge and best practices within and across the organization.
Work Location Assignment: On Premise
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The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% 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.
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