Regulatory Affairs And Clinical Trial Manager

REGULATORY AFFAIRS AND CLINICAL TRIAL MANAGER

Versatile, results-driven professional with 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 ● Regulatory Compliance and Quality Assurance ● Standard Operating Procedures ● Periodic Review ● Study startup/closeout ● IRB Submissions ● Good Clinical Practice (GCP) ● ISO 15189 ● Technical Writing ● Project Management ● ISO 13485:2016 ● eCTD ● Nonconformance ● Configuration Management ● Information Technology ● Medical Terminology ● Process Improvement ● HIPPA Compliance 510K FDA submissions ● Medical Device Registration ● Clinical Evaluation Report Writing ● Quality Management System

EXPERIENCE

LABCORP DRUG DEVELOPMENT, Indianapolis, IN 6/2021 –present

QA Compliance Lead Auditor

Hosts external/internal audits/inspections e.g. regulatory inspections, sponsor and departmental audits.

Provided subject matter expertise, leads and influences the organization by providing guidance and client facing support on regulatory topics.

Ensure Regulatory Compliance and Quality Assurance responsibilities are followed.

Leads the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (monthly reports, site quality review, liaison meetings).

Facilitates and reviews audit responses and CAPA plan creation.

Ensures monitoring of Data Loss Prevention through investigation of quarantined emails.

ELI LILLY AND CO. for ALLSTEM, Indianapolis, IN 11/2020 – 6/2021

Clinical Regulatory Associate – Global regulatory registrations

Provided Regulatory & Drug Development expertise by leading the registration management process by providing expertise in electronic submission regulations and guidance and technical content for FDA and global submissions including all submission types (Ad Promo, INDs, NDA, BLAs, NDSs,other eCTD MAAs, Renewals and Variations.

Partnered with other geographies to understand and incorporate local agency regulations and requirements as needed for electronic submissions in those regions who have and are adopting the eCTD specification.

Owned the routine compliance submissions and processes for molecules within areas of assigned responsibility (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions).

Partnered with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process.

PULMODYNE INC., Indianapolis, IN 12/2017- 11/2020

Regulatory Affairs Manager- Medical Devices

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

Authored over 20 clinical evaluation reports to provide the evaluation of clinical data to demonstrate the intended indications and claims for medical devices are achieved, reducing company costs by $22,000 from outsourcing.

Mediated 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.

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

Assessed Customer Complaints and CAPAs

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

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

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

Directed project management discussions to provide technical guidance and training to cross-functional teams (engineering, sales).

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

Organized and coordinated 15 clinical studies, assisted with protocol development and IRB submissions.

Supervised subject recruitment and study enrollment goals.

Led a team of ten as Study Lead on 4 Heart Failure Investigator lead studies. Screened and enrolled on 11 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

Executed 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.

Utilized 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 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. Collaborated as the liaison with IT for system issues.

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, and non-compliance.

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

Advised 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 for four employees.

Redesigned 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)

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.

Represented 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 (query resolution, EDC), site monitoring, and closeout of 7 ongoing clinical research studies in various Phases.

Software Skills

Regulus ● TrackWise ● Microsoft Word ● Excel ● PowerPoint ● Visio ● Outlook · SharePoint · Lotus Notes ● Documentum ● ServiceNow ● LabelMatrix ● Microsoft Office ● Medidata Rave ● InForm ● REDcap ● Veeva Vault ● RIM ● eCTDxpress ● TEAMS ● Citrix

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, MD

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