subject matter expert data analyst iii resume example with 9+ years of experience
Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Summary
COMPLIANCE CONSULTANT
Pharmaceutical | Life Sciences and Drug Review
Forward-thinking and proactive troubleshooter with 5+ years of pharmaceutical experience in improving public health and excellence
in risk management by developing quality compliance solutions
VALUE OFFERED:
Intellectually curious and diligent approach in drilling down to root causes then creates quality-driven solutions that helps
companies stay within compliance requirements.
Subject matter expertise in U.S. Food and Drug Administration (FDA) regulations pertaining to post-market safety surveillance risk
assessment.
Thorough and pinpoint accuracy in leading audits and assessing risks; leverages technical expertise in risk management and
dealing with deviations / corrective and preventive actions (CAPAs).
Detailed, transparent, and timely communicator ensuring all stakeholders are kept informed on issues, solutions, and potential
upcoming changes.
Cross-functional fluency in working within high pressure matrixed environments and presenting to technical and lay groups.
CAREER EXPERTISE:
Client Engagement | Deviations/Corrective and Preventive Actions (CAPAs) | Risk and Trends | Audits | Triages | Compliance Review
Inspections | Public and Private Sector | Risk Consulting | Compliance Monitoring | Regulatory Affairs | Technical Writing
Product Risk | Market Access and Reimbursement | Investigations | KPIs | Risk Minimization | Technical Writing | Security and Privacy
Project Management| FDA Implementation | Analytical Thinking| Launch | SOP | Service Level Agreements (SLAs)
Proficient in SharePoint, Electronic Drug Registration and Listing System (eDRLS), Salesforce, Clinical Trials Reporting Program (CTRP),
Scientific Trials Analytics Platform (STRAP), Prometric, and MS Office (Access, Excel, OneNote, Outlook, PowerPoint, Teams, Word).
Skills
Guest services
Inventory control procedures
Merchandising expertise
Loss prevention
Cash register operations
Product promotions
Education and Training
Aurora UniversityAurora, ILExpected in ā āBachelor of Arts (BA):Political Science - GPA:
Experience
Walgreens - Subject Matter Expert - Data Analyst III Norristown, PA, 06/2019 - Current
Recruited into role based on subject matter expertise in risk evaluation and mitigation strategies (REMS) dealing with deviations /
corrective and preventive actions (CAPAs) to help provide strategic goals for shared REMS
Review 40+ risk assessments / year of up
to 10,000 pages per application to capture deviations / corrective and preventive actions (CAPAs) and provide risk evaluation feedback
to senior leadership
Assist with the development and implementation of compliance programs by creating risk-based metrics for
upcoming inspections
Participates in compliance monitoring and audit activities to draft guidance to improve risk management
strategies in implementation, launch readiness, deviation history, assessment reviews, and pre- / post-inspections
Create rubrics for
assessments that are in alignment with current FDA requirements / regulations to guarantee risk communication measures and
necessary compliance improvements are being met
Create training content for investigator training that helps supports outgoing
communication, audit documentation, remedial actions development, implementation and tracking, audit preparations, reports, and
meeting logistics
Erased inter-departmental communications silos which improved collective REMS trend understanding and created better-
informed REMS modification approvals / denials; set quarterly meetings and improved information-sharing regarding
assessment issues, due date changes, deviation updates, inspections, and compliance needs clarifications
Strategical planning enabled company to provide needed metrics after creating data-informed business case proposing review
every REMS inspection to build metrics for future use in determining applicant holder compliance; won leadership approval
which proved fortuitous as FDAās new CDER director requested stats on opioids and inspections as top agenda item
Enhanced risk minimization and mitigation evaluation methods by zeroing in on applicant holdersā compliance history;
exported applicant audits to reveal deviations / CAPAs and built risk-based tracker capturing data points that highlighted at-risk
applicants and best practices for future inspections
Manage REMS and Pharmacovigilance compliance teams' inbox for sensitive information submissions, program
inquiries/compliance complaints, consultation requests; ensuring timely triage, response and resolution to identified issues and
providing responses to participant inquires
Data-mined through 4,000+ data records from outdated pharmacovigilance records to create new site selection tool which
provided acquisition / merger info as well as drug products / application status; used risk-based assessment tool for fiscal year
inspections
Discovered 10+ major modifications affecting timetable submission changes and saved senior management team 5+ hours of
work coordinating with legal department to start enforcement action on late submissions; created new REMS modification tracker
and regularly checked for crucial REMS@FDA updates to stay up-to-the-minute on changes
Built REMS implementation strategy workgroup foundation that reduced chronic compliance issues; drafted guidance for
current shared REMS challenges across therapeutic areas and outlined how to assist future applicant holders on implementation
dates and pre- / post-launch readiness plan.
ESSENTIAL SOFTWARE INC - Protocol Data Analyst City, STATE, 07/2018 - 06/2019
Referred into role after business contact made recommendation for hire
Tasked to solve accrual issues and submit data table (DT4)
reports for NCI-designated cancer centers; stayed within strict guidelines of mandates
Managed 80% of accrual issues (9,000
differential issues) and submission inquiries
Generated and reviewed DT4 Reports for ongoing discrepancies in Scientific Trials
Analytics Platform (STRAP) and various NCI databases
Ensured each milestone was achieved ahead of cancer center final DT4
submissions
Hand-held cancer centers through Data Table 4 (DT4) report submittals to help retain their NCI-designated cancer center status
and continue receiving grant funds; dedicated more 1:1 time and discussed discrepancies during calls
Achieved 100% accuracy of abstracted data from trial submissions by sponsors (protocol, IRB, patient consent, and various
documents); following information verification by trial submitter(s), trials are posted on www.cancer.gov
Resolved end users trial submission issues for Center for Cancer Research (CCR) trials (designated cancer centers) to add
themselves as participating sites to ClinicalTrials.gov; imported NCI trials and registered them into CTRP database.
CAREMETX - Specialty Pharmacy City, STATE, 10/2015 - 07/2018
Recruited by VP based on quality / auditing experience at Cardinal Health specialty pharmacy
Served as subject matter expert for
REMS Administrator processes and audited 85+ cases across therapeutic areas daily to ensure high quality performance and adherence
to FDA REMS regulations
Championed compliance to SOPs and SLAs and managed 5 quality analysts to ensure alignment with federal
regulations: recommended corrective and preventive actions (CAPAs)
Maintained and managed hospitals and pharmacies REMS
certification / decertification processes and monitored key performance indicators (KPIs) to keep them on track to being met across
all channels
Managed database of 10+ specialty pharmacy friction points to improve quality of team culture/performance and
enhance patient experience
Created reimbursement trends/updates for internal/external stakeholders; mapped out commercial coverage of REMS products
vs Medicaid/Medicare, copay card assistance, and bridge/Patient Assistance Program needs
Eliminated chaos caused by multiple specialty pharmacies competing to service patient REMS prescription requests by
providing REMS Hub operation workflow for case managers and ensuring requests would be handled urgently
Partnered with IT department to map out change requests for multiple program launches, i.e.: stop codes, program ID, non-
consented/consented, status code vs sub-status code, and etc
To make data feeds consistent across 12 specialty pharmacies
Led
meetings with third-party data aggregator to help implement the changes
Delivered 40% decrease in data errors and ensured consistent specialty pharmacy communications; identified chronic root
cause of issue and met with each specialty pharmacy to discuss pain points and ways to work together better
Managed migration of 18,000 patient database to ensure no deviations while avoiding fines and potential FDA audits;
segmented database based on patient risk factors and medication histories to eliminate mismatching while working with 3rd party
pharmacy data aggregator
Slashed deviations from 50+ daily down to <5 to cut hefty fines; created work Instruction breaking down pharmacy codes for
each specialty pharmacy and trained case managers to help them understand data feeds better.
CARDINAL HEALTH - Senior Pharmacy Technician City, STATE, 02/2012 - 03/2015
Recruited into position serving as reimbursement and market access expert; reviewed pharmacy benefit claim issues to identify
patients and healthcare professionals access hurdles then reported findings to senior leadership
Pioneered changes to address claim issues that cut processing times from 12-48 hours to 1-2 hours and eliminated SLA fees
for delays; recommended issues be sent to dedicated pharmacy technicians and pharmacists to cut backlog
Decreased patient call volumes by 50% and reduced violation of Service Level Agreement (SLAs) fines by $10,000 daily; cut
patient backlog by adding patient profile element to their file post-verification that cleared prescriptions faster
Saved company $15,000 on daily basis by conducting 60+ audits daily to ensure key performance indicators (KPIs) were met
Reduced quarterly audit SLA violations by 30ā40%; generated historical and analysis reports and provided recommendations to
senior leadership to help avoid repeat or chronic issues
Eliminated 3 days from medication shipping delays after implementing quality assurance measures and defining new procedures
that optimized staff data entry.
Additional Information
NOTABLE ACHIEVEMENTS:
, CDER Honor Award, Office of Compliance, REMS āFor ensuring CDER regulated products are safe and effective for the life of the
product,ā U.S. Food & Drug Administration (U.S. FDA) (2021)
CDER Honor Award, Office of Compliance, Pharmacovigilance (PV) āLeadership, development, and implementation of the first site
selection tool for Pharmacovigilance inspections,ā U.S. Food & Drug Administration (U.S. FDA) (2020)
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