Patsy Scott Email & Phone Number

•Develop governance process & policy of U.S. licensing requirements for each state’s Board of Pharmacy (BoP) which includes initiating new applications, maintaining, and monitoring licensure status, issue escalation, agenda topics, meeting minutes; establish metric tracking & trending.•Develop tools, e.g., work instruction, Designated Representative (DR) acknowledgement letter, training requirements.•Establish DR/Corporate Officer, minimum requirements, roles & responsibilities for each facility.•Facilitate completion of state license applications, background information, reviews & reduce compliance risks.•Collaborate with Project lead on source documentation/information needed for licensing application including collection of DR & Corporate Officers records, inspection reports (e.g., state DoH, FDA), device listings, site registries, Invoices, 3PL, CMO agreements, Corporate Certificates (good standing, articles), site photos.•Respond to state board of pharmacy requests.•Collaborate with Cross functional teams e.g., Deliver, Tax, Legal; recommend updates to Enterprise/Local P&Ps, as needed.•Establish a validated database for storage of license related documents & communications with state agencies. •Partner with project lead on establishing site/legal entity responsibilities & portfolio management

Sunnyvale, California, United States

•Expert resource in applicable standards and QMS requirement knowledge for cross-functional teams.•Improved Internal Audit Program compliance to applicable laws & regulations & internal procedures.•Developed a new EA policy, revised audit playbook.•Created announced and unannounced audit communications, audit checklist, storyboard templates, guidance on conduct during external audit, backroom norms, and issue escalation during external audits. •Led Global Audit planning strategies on inspection readiness activities e.g., training, SME/Stakeholder (identification, awareness, support) logistics, best practices; developed backroom process for managing/fulfilling requests, issue escalation & communication & daily (wrap-up/follow-up) communications on potential findings. Managed front room & fulfillment of audit requests.•Successfully managed Global DNV Notified Body Audits for Phoenix, Germany & Southaven sites during unannounced FDA inspection.•Influenced on IA/EA, QMS, without authority across functional groups, regions, and to Stakeholders. •Provided day-to-day operations and Compliance team support in the absence of a Sr. Manager.•Developed practical process & systems solutions to improve complex problems.•Revised Internal Audit Global procedures, schedule, audit plan, report & audit dates to align with regulations.•Led team(s) to remediate audit findings, conduct robust investigations, timely CAPA execution, documentation & closure, & reduce risks after measures have been implemented to mitigate existing risks. •Led backroom during mock audit.•Mentored and coached new employees.•Ensured KPIs for the department were met.

Jacksonville, Florida Metro

•Maintained & supported the IA Program; led strategic planning efforts; ensured KPIs for the department were met; compiled RC audit metrics for Management Review. •Planned & conducted risk-based internal audits against internal policies & medical device regulations including 21 CFR, ISO, MDSAP, EU MDR . Authored observations & presented during calibration; authored audit reports, distributed to stakeholders, maintained records in audit system. •Initiated CAPAs, provided compliance expertise supporting owners. Promoted robust investigations, monitored progression & timely documentation of activities/closure.•EA roles included key contact person for NB, inspection readiness, logistics management, backroom lead, front-room co-host, scribe. •Facilitated development of new auditors w/lead auditor training courses, mentorship, coaching, shadowing & functioning as team auditor.•Developed footprint for remote IA during Covid and facilitated hybrid Notified Body audits; facilitated ongoing EU MDR global training & assessments for stakeholders & acknowledgement of responsibilities.•Led site Data Integrity governance processes & policy development; Led dynamic audit readiness corporate initiative to assess local gaps, developed process management & communication templates.•Facilitated global training & competency assessments for combination product medical device w/pharmaceuticals; conducted gap assessments of enterprise/local procedures against regulations; revised/created new/archived procedures.•Managed 3rd Party RM assess; facilitated training & gap assessment of enterprise/local RM procedures.•Compliance lead for R&D & Clin. Ops & NPI. •Quality Management stretch: Led Quality System projects (1)Established Franchise DRB Quorum (2) Gap assessment of ICQAs; revised/drafted new agreements (3) Cross-functional global team member for harmonization of corporate procedures, doc. control system migration.•Other essential duties as needed.

Jacksonville, Florida Metro

•Managed global MDR/Vigilance complaints & investigations US & OUS affiliates, legal teams, and call center determining, coding and reportability.•Submitted global MedWatch/Vigilance SAE reports; 100% submitted on time. •Monitored robustness of investigations, root cause analysis and appropriateness of actions to resolve issues.•Tracked & trended product complaints, inquiries & closure.•Data reports for complaints & PMS signals. •Mentoring and fostering professional development of new/existing employees.•Ensured KPIs were met.•Supported Post-Market Surveillance activities & Program development including investigations and corrective actions resulting from complaints and field actions.•Promoted customer satisfaction & resolutions.•Led R&D PI initiatives to meet regulatory reporting requirements for TA related SAEs, product return & evaluation. •Developed auditing tools including medical complaint investigation (CI) form, used globally to collect clinical information from affiliates, eye care professionals & patients. Use of the form ↑ efficiencies in gathering medical information by 60%. •Developed SAE quarterly internal MDR Assessment, peer review process; created escalation process for discrepancies and mitigation. •Developed department KPIs. •Collaborated with Post-Market Safety, R&D, Engineering regarding complaint data for NPI, legacy product to mitigate risk, assess the need to update DMRs, improve product quality. •Provided mentorship to less experienced and new team members.•Other essential duties as directed.•Clinical Operations Stretch Assignment: Developed clinical trial SOPs & process for managing TA delivery/resolution, complaints & AE reporting & returns. Supported clinical operations w/managing study protocols, consent forms, investigator’s brochures, P&P.•GROW Program (2014-2015), RC, LA Training(2013), RABQSA Oriel-Stat-a-Matrix. 21 CFR part 11, 803, 806, 820 and ICH guidelines.

New Orleans, Louisiana, United States

•Quality management & process improvement (PI) integrating National Patient Safety Goals(NPSG) into compliance & risk management(RM), change management. •Conducted investigations on cardiac related deaths & medical device surgical adverse events.•Led complaints investigations, FMEA to identify system/process failures & CAPA initiation. •Coached employees on CMS guidelines, laws, and best practices in healthcare organizations.•Conducted chart reviews (concurrent/retrospective). Used Quality indicators for hospital DRG. •Ensured adherence with CMS & private insurance medical coding & billing requirements.•Entered medical data into the Quality Net Exchange system & Submitted core measure data to Centers for Medicaid and Medicare Service (CMS). Collected Core Measure Data for diseased states & mortality rates. •Integrated data from operative & invasive studies, blood use, near misses, mortality rates & medication usage into the peer review process & physician profiles. •Managed physician eligibility using inputs from compliance scores & peer review. •Developed clinical pathways focused on risk management & measures to decrease mortality rates. •Created weekly agendas for patient care with collaboration from multidisciplinary teams. •Conducted mock survey inspections. Hosted during JCAHO inspections (zero observations).•Established effective relationships with regulatory agencies & key decision makers. •Used CMS guidelines/InterQual to determine levels of care.

New Orleans, Louisiana, United States

•Conducted concurrent clinical reviews & reported outcomes via designated tracking system. •Retrospective & concurrent chart reviews for Medicaid reimbursement . Liaison for administration, & ancillary departments regarding revenue/compliance issues. •Ensured adherence with CMS & private insurance medical coding & billing requirements.•Implemented Quality & PI initiatives. Integrated NPSGs into RM programs. •Ensured KPIs for the department were met.•Mentored and coached less experienced staff on managed care regulations and training requirements.•Managed educational training & certification in Utilization Management for case managers, patient access & billing. •Resolved denial issues related to DRG procedures/admissions and appealed denied hospital stays. •Supported mitigation efforts including CAPAs & promoted collaborative efforts with physicians, case managers & relevant ancillary departments. •Led Medicare 1-Day Length of Stay project, mandated by CMS to correct billing errors. •Developed Policy for Medicare(CMS) 1-Day Length of Stay eliminated DRG upcoding, ↓ billing errors, documentation issues & denial rate to ↓ 5% for retrospective reviews. InterQual & Milliman used to determine levels of care.

New Orleans, Louisiana, United States

•Medical & Behavioral Health Case Manager. Conducted chart audits & discharge planning; managed denials/appeals Healthcare compliance Medicaid, Medicare, & private insurance regulations. Ensured adherence with CMS & private insurance medical coding & billing requirements. InterQual and Milliman criteria used to determine levels of care

Metairie, Louisiana, United States

•Pre-certified durable medical equipment(DME), outpatient & inpatient admissions using Inter-qual/M&R requirements; conducted clinical chart audits. Ensured adherence with CMS & private insurance medical coding & billing requirements. InterQual and Milliman criteria used to determine levels of care

Bachelor Of Science, Nursing

Associate Degree, Nursing

License Practical Nurse