EXPERT REGULATORY AFFAIRS AND CLINICAL TRIAL MANAGER

Versatile, results-driven professional with 20+ years of comprehensive experience developing exceptional relationships with clients, peers, and senior leadership to provide sustainable business solutions. Superb project leadership abilities and personnel management skills with expertise in the medical device, pharmaceutical and clinical trial sectors. Proven problem solving and analytical thinking skills, a fast-learning curve, and ability to adapt to evolving industry trends. A dedicated professional with the drive and skill-set to excel in a fast-paced role.

CORE COMPETENCIES

Data Management ● Data analysis/tracking ● Clinical Trials ● Documentation Management ● Correction and Prevention Action (CAPA) Training Compliance ● Quality and Regulatory ● Regulatory Intelligence ● Audits ● Training Development ● Document Routing and Approval ● Standard Operating Procedures ● Labeling ● Study startup/closeout ● IRB Submissions ● Good Clinical Practice (GCP) ● FDA Guidelines ● Technical Writing ● Project Management ● ISO 13485:2016 ● Writing/Editing ● Nonconformance ● Quality Control ● Configuration Management ● Information Technology ● Medical Terminology ● Process Improvement ● HIPPA Compliance 510K FDA submissions ● Medical Device Registration ● Clinical Evaluation Report Writing ● Quality Management System

EXPERIENCE

PULMODYNE INC., Indianapolis, IN 12/2017- present

Regulatory Affairs Manager- Medical Devices

Processing of medical device license applications for product development, international submissions, renewal and foreign distributor registrations.

Created clinical evaluation reports to provide the evaluation of clinical data to demonstrate that the intended indications and claims made for medical devices are achieved.

Conducts global project management discussions with over 25+ stakeholders to ensure quick product registrations.

Expertise in Design Dossiers, Technical Files and Clinical Evaluation Reports for European CE marking and FDA submissions.

Performs Internal Audits per ISO 13485:2016, FDA requirements and Quality Management System requirements.

Processing of Customer Complaints and CAPAs

Maintains current knowledge of US and international regulatory requirements including clinical regulations, design control,

labeling regulations (eIFUs), risk management, auditing principles, and adverse event reporting.

Proficient in Health Canada, US FDA, Medical Device Directives (MDD) and Medical Device Regulation (MDR).

Conducts project management discussions to provide technical guidance and training to cross-functional teams.

Knowledge of Quality System Regulation (21 CFR 820) and Quality Management System (ISO 13485:2016)

INDIANA UNIVERISTY SCHOOL OF MEDICINE, Indianapolis, IN 05/2017- 12/2017

Clinical Research Specialist- Department of Emergency Medicine

Conducted and coordinated clinical studies / trials and assisted with protocol development.

Supervised subject recruitment and study enrollment goals.

Evaluated adverse event data and assisted with making IRB submission decisions.

Acted as Study Lead on 4 Heart Failure Investigator lead studies. Screened and enrolled on 15 other studies (PE, TBI, HF, Trauma).

Processed lab specimens and storage per protocol on enrolled subjects.

ELI LILLY AND CO. for COMPUTER TASK GROUP, Indianapolis, IN 07/2014 - 02/2017

Global IT CAPA and Documentation Specialist- Information Quality Systems

Processed approximately 200 daily global IT Correction and Preventative Actions (CAPA) within 81 defined areas.

Acted as administrator of CAPA system, including maintenance of director level plans, weekly CAPA and document review metrics and quality scorecards covering Deviations, Periodic Reviews, Disaster Recovery documents, Self-Inspection, and audits as well as area defined metrics.

Effectively used business processes relating to reviewing and approving routing notices for documents of all types as well as records management across various departments.

Created electronic training from approved, processed documents into the Learning Management System (LMS).

ELI LILLY AND CO. for CORPORATE BROKERS, Indianapolis, IN 05/2013 - 07/2014

Regulatory Intelligence Consultant- Pharmaceuticals

Supported the Regulatory Scientists in developing and refining the regulatory strategy, including using the information to challenge and influence the regulatory strategies based on industry precedent and new developments.

Identified and accessed relevant information sources (Food and drug advisory meetings, Drug Approval Packages, Publications) and established sustainable databases for regulatory information summarizing regulatory Intelligence.

Identified and provided opportunities to improve company processes and products based on regulatory intelligence information obtained.

Provided Chronic Pain deep dives on various molecules to present to the regulatory scientist.

ROCHE INSULIN HEALTH SOLUTIONS for ADECCO, Indianapolis, IN 06/2011 - 02/2013

Documentation Specialist and Training Administration Specialist - Quality & Regulatory

Administered systems (i.e. e-Doc, DMS/SAP, Configuration Management) and databases. Set up permissions, and created new workflows and document types. Served as the liaison with IT for system issues. Created and implemented approval of documents and permissions. Developed technical curriculum, course design, training effectiveness and compliance.

Managed the quality control program assessments by conducting quality internal audits to identify best practices, non-compliance, and errors.

Acted as administrator for assigning and training new employees in the Learning Solution System (LSS).

Served as Interim Infection Control Monitor reporting physiological effects resultant from use of infusion sets utilizing reports for trending.

Reviewed and analyzed annual Regulatory Employee Compliance Competency Assessments based on the employees work via random sample for pMDRs and spot checking of MDRs.

Created and revised all Roche IDS Standard operating procedures to align with process improvements and new roles.

Contributor to the Roche Health Solutions Correction and Preventative Action team (CAPA)

Assisted marketing with labeling development

HEMATOLOGY ONCOLOGY of INDIANA, Indianapolis, IN 07/2010 - 06/2011

Clinical Research Assistant Coordinator

Assisted with patient Informed Consents and clinic research visits. Including scheduling lab, x-ray, scans and patient visits.

Submitted IRB required documents and maintained approved protocols and amendments.

Served as main contact for study monitors and CRAs.

Assisted with recruiting, selection and screening of participants for clinical trials.

Coordinated and conducted all activities in initiating (start-up), data management (data entry, query resolution), site monitoring, and closeout of 7 ongoing clinical research studies in various Phases.

ELI LILLY AND CO. for UNYSIS, Indianapolis, IN 04/2009 - 11/2009

Global Documentation Specialist and Training Coordinator

Processed hard-copy and electronic global company documents such as standard operation procedures and operational instructions through technical writing and editing.

Validated qualification documentation required for any project, such as plans, scripts, cases, reports.

Produced system documentation from the content provided by subject-matter experts (SMEs).

ELI LILLY AND CO. for VOLT, Indianapolis, IN 12/2006 - 10/2007

Medical Regulatory Associate-Endocrine (diabetic) Studies

Tracked study metrics (% sites regulatory ready), created and maintained regulatory document trackers and approved site-specific IRB-approved ICDs.

Prepared and assisted in preparation for FDA audits/inspections.

Submitted IND information to US Regulatory Affairs for study investigators such as preparation of 1572s, CLIA certifications, CV and license requests.

Conducted project management discussions with sites to ensure site is meeting its deliverables and communicated with team members to ensure quick and accurate regulatory approvals.

Approved key deliverables (i.e. Data Quality Delivery Plan, Datalock Plan, Project Plan, database, and observed datasets).

ELI LILLY AND CO. for MEDFOCUS, Indianapolis, IN 07/2004-11/2005

Clinical Data Manager - Neuroscience Trials

Maintained global data quality and consistency within the clinical data management infrastructure which includes data collection, data validation, data archiving, enforcement of data standards, and process improvement through GCP.

Managed investigation of Adverse Events and reporting.

Created patient summaries for FDA submissions for clinical trial patient dropouts.

Managed adverse event reporting from scientific literature by collecting, reviewing, and entering global adverse events reports. Routing applicable literature on adverse event cases to the appropriate clinical safety physician for review.

Software Skills

Regulus (Expert) ● TrackWise (Moderate) ● Microsoft Word (Expert) ● Excel (Moderate) ● PowerPoint (Moderate)

Visio (Moderate) ● Outlook (Expert) · SharePoint (Moderate) · Lotus Notes (Moderate) ● Documentum (Moderate)

ServiceNow (Expert) ● LabelMatrix ● Microsoft Office (Moderate)

EDUCATION

Butler University, Indianapolis, IN - BS. Biology/Pre-Pharmacy

Butler University/Indiana University Health, Indianapolis, IN - Emergency Medical Technician Certification

Indianapolis University/Purdue University, Indianapolis, IN - Clinical Research Coordinator Certification

Internal Auditor Training- ISO 13485:2016 -OrielStat

5S/ Lean Project

CITI Certified 2017-GCP and Biomedical Researcher, Clinical Research Coordinator

Training 2017- Lab Safety, Bloodborne Pathogen, Hazardous Material Shipping, HIPAA, Shipping of Biological Material, Biosafety

Certified to perform Lung Ultrasound Scans to assess B-Lines for congestion

Lead Study Coordinator- B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure (BLUSHED-AHF) Pilot Trial, Principal Investigator: Peter S. Pang MD

Lead Study Coordinator- High Sensitivity cTnT Rules Out Acute Cardiac Insufficiency Trial (TACIT), Principal Investigator: Peter S. Pang

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