Position PurposeAs a member of the Clinical Bioanalytics (CBx) Business Operations and Compliance Team within Translational Clinical Sciences, the Business Operations Manager will serve as a key point of contact for the team by leading or significantly contributing to any of the following CBx processes: finance, contracting, vendor management, quality management systems, document management and associated systems, CBx process systems, audit/inspection management, GSOP review and compliance, and data review/QC. The Business Operations Manager, as an integral member of the CBx Business Operations team, will actively seek and drive efficiencies to improve processes while collaborating with internal partner lines to ensure compliance.
Organizational Relationships:- Reports to Business Operations and Compliance Group Lead,
- Frequent interaction with colleagues within CBx, Clinical and Translational Biomarkers, PharmSci, Global Procurement, Finance and Contract Research Organizations (CROs)/external collaborators, as appropriate.
- Member of CBx Business Operations and Compliance Team.
Primary Duties:- Serve as contracting and finance subject matter expert and main point of contact (POC) for Clinical Assay Leads and external vendors
- Draft, review and execute all CBx contracts to support critical timelines on behalf of Clinical Assay Leads
- Engage external vendors and manage contract life cycle
- Collaborate with Global Procurement to effectively life-cycle manage MSAs for CBx vendors
- Develop and/or improve tools for tracking and real time analysis of CBx financial data
- Coordinate within CBx, Finance, Clinical teams and CROs to ensure timely resolution of issues and in generation of Purchase Orders (PO) and invoices.
- Oversee and provide operational support for multiple Business Operations initiatives within CBx
- Serve as the SME and primary point of contact within CBx for one or more key systems/processes, including but not limited to TMF, Portfolio on Demand, Buy on Demand, Veeva and/or Submission Ready Document QC
- Maintain best documentation practices by effectively managing, storing and distributing necessary contracts or reports
- Perform redaction of contracts and MSAs for vendor sensitive (pricing and confidential) information for regulatory purpose (e.g., HGRAC and health authorities’ inspections, external audits by the third parties).
- Partner with key functional lines to establish and maintain business operations best practices
- Prepare and critically review key CBx metrics on a quarterly and annual basis
- Perform document and process management by capturing financial and/or bioanalytical study/report entries in appropriate systems.
- Assist in creation of appropriate Job Aids.
- Follow and contribute to internal best practices and processes consistently and ensure that quality meets Pfizer standards while harmonizing and enhancing productivity
BASIC QUALIFICATIONS
- B.S. degree with a minimum of 5 yearsor Masters degree with a minimum of 3 years' experience in Pharma or CRO or Sourcing Group(s).
- Experience in vendor oversight
- Understanding of GxP principles (e.g., GCP, GCLP) within a regulated clinical or bioanalytical environment
- Detail oriented and possessing strong verbal, written and presentation skills.
- Proven ability to effectively multitask and work in a highly matrixed environment.
- Highly proficient in using MS Word, Excel and PowerPoint
PREFERRED QUALIFICATIONS
- Background in regulated bioanalytical method validation and sample analysis
- Familiarity with AI tools, Veeva and/or document management systems (i.e. GDMS)
- Handson experience leading or significantly supporting negotiation and execution of bioanalytical vendor contracts
- Self-driven, having strong time management skills.
- Demonstrated ability to plan, manage and support business operations.
- Ability to work independently and operate under minimal supervision.
- Experience in drug development.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require occasional travel to other Pfizer sites.
Work Location Assignment:Hybrid
The annual base salary for this position ranges from $93,600.00 to $156,000.00. In addition, this position is eligible for participation in Pfizers 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 lifes 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.
This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
