PUBLISHER III, SUBMISSION OPERATIONS, REGULATORY AFFAIRS
To obtain a position that further develops the skills and knowledge needed in pursuit of career advancement in the field of Regulatory Affairs within a Pharmaceutical environment
Publisher III, Submission Operations, Regulatory Affairs, 10/2012
to Current AbbVie Inc – North Chicago,
Publisher III, Submission Operations, Regulatory Affairs - PPG Provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and procedures.
Prepare, check, publish and submit multiple types of regulatory submission documents to both US and ex-US authorities.
Apply current regulatory requirements to improve processes.
Solve complex process- or submission-related problems.
Represent Regulatory Affairs on global teams and act as Subject Matter Expert (SME).
Duties include: complete timely, accurate complex submissions; work with global teams to create compliant submissions; understand use of planners and question inconsistencies or exceptions; understand current procedures and participate in improving them based upon relevant experience; assemble eCTD (if applicable) by placing documents and links in correct modules; perform detailed QC of submission documents, including review of others' work; resolve problems independently; demonstrate expertise with systems and applications (i.e.
eDocs, Sharepoint, eCTDXPress, fileshares, Adobe, Word); represent Submission Operations on limited duration teams; provide SME input; create content for cover letters or other Agency communications (at the direction of the RA Lead).
Regulatory Affairs Associate, 03/2010
to 10/2012 Collaborative LLC/Manpower Regulatory Affairs - PPG Abbott Laboratories – Abbott Park,
Responsible for routine regulatory support and for providing guidance to support timely filings and maintenance of assigned programs.
Assist in managing time-sensitive submission projects.
Preparing, reviewing and finalizing safety reports for preparation of IND submissions pertaining to the Investigational New Drug (IND) for FDA submissions.
Perform quality assurance checks for all documents prior to FDA submissions.
Extensive communications with Directors and Senior Directors pertaining to FDA reports, submissions and special projects.
Daily communications with the PPD-IND Pharmacovigilance and Safety Group as it relates to Safety Reports.
Reconciling responses from the FDA, providing information to the FDA, medical writing and other clinical teams.
Extensive knowledge and experience with ICH/GCP guidelines.
Additional responsibilities include performing electronic FDA submissions for the following IND documents
Senior Records Technician, 09/2008
to 03/2010 Delta Pharma, Inc Takeda Global Research & Development – Deerfield,
Correctly index, catalog, and import electronic records into the electronic record management system (RMS); verify the accuracy of the indexing, cataloguing and filing information entered into RMS, using standard features of the RMS together with business tools such as MS Excel and standard procedures.
Verify the accuracy of the indexing, cataloguing and importation of electronic records by RMS Users outside of the Record Operation function, and files those records into the correct location within the File Plan.
Assist members of departments outside of the assigned Records Operations function in finding needed records by using standard features of the RMS, together with knowledge of the file plan and the records' subject matter Copy electronic records to appropriate media or locations and create appropriate folder structures or indices to assist requestors in locating the records requested on the media provided.
Under limited supervision, leads and/or participates in special projects related to records intake or records production, such as would occur during audits and inspections.
Initiates and documents suggestions for improvement of work processes, written procedures, training materials and the RMS.
Assist in performing routine quality control procedures to verify quality of records management data in the RMS.
Maintains orderly work space; advises management when supplies are needed.
When needed to meet workload demands, fulfills the responsibilities of a Records Technician for physical records.
Clinical Trial Coordinator, 09/2007
to 07/2008 ReSearch Pharmaceutical Services, Inc TAP Pharmaceutical Products Inc – Fort Washington,
Support the operational activities of clinical studies in accordance with CFR, ICH Guidelines, GCPs, and TAP's PPGs.
Primary contact for the management of regulatory documents for clinical sites and study team.
Collect and track all study documents required throughout the study.
Review documents for quality and completeness in accordance with the regulations and the study protocol.
Work closely with CTL or Clinical Trial Associate in organizing and executing prestudy activities.
Manage the distribution of communications to all sites (e.g.
questionnaires, study synopses).
Manage the submission of required documentation to the central IRB to obtain approval.
Ensure adequate study supplies are provided to the clinical sites throughout the study.
Ensure all study-related parameters are.
tracked appropriately and kept current in eClinical.
Complete drug shipment forms and obtain necessary approvals to ensure timely shipment of study drug.
Track the distribution of study drug to sites throughout the study and work with CTL and monitoring.
staff to complete overall drug reconciliation.
Cross-functional collaboration with the Records Operating Center (ROC) to fully eliminate backlog of filing documents by close of 2007.
Clinical Research Coordinator, 06/2006
to 09/2007 Alexian Brothers Hospital Network – Elk Grove Village,
Liaison between the investigators, primary care providers, institutional review board (IRB) and the sponsor.
Perform sound conduct of clinical trials according to GCP guidelines, including but not limited to, recruitment, screening, enrollment and follow-up of eligible subjects according to protocol requirements (e.g., subject follow-up, case report form completion and adverse event reporting).
Maintenance of accurate and complete documentation, including but not limited to, regulatory documents, signed informed consent forms, relevant IRB approvals, source documentation and study-related communications.
Organizational management of all aspects of clinical trials, including but not limited to, timeliness in completion of case report forms, data entry, adverse event reporting, managing caseload and managing study files.
Communication of all protocol-related issues to the appropriate management staff, including but not limited to, questions regarding the conduct of clinical trials and concerns regarding possible adverse events or subject compliance.
Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.
Clinical Research Coordinator, 05/2005
to 06/2006 Radiant Research – Chicago,
Medical/Research Assistant, 11/2004
to 05/2005 Radiant Research – Hoffman Estates,
assist physicians in patient care; obtain medical history, vital signs, perform EKGs, collect and process diagnostic specimens.
Medical Assistant, 07/2003
to 08/2004 Northwest Gastroenterologists, S.C – Arlington Heights,
Assisted 7 physician practice in patient care.
Medical Assistant, 07/1998
to 07/2003 Medicine, Ltd – Arlington Heights,
Assisted 5 physician practice in patient care Duties included
Bachelor of Arts: Psychology Biology, Chemistry, Physics, and Psychology,
5 1998 University of Illinois - Chicago Psychology Biology, Chemistry, Physics, and Psychology
5 1995 Loyola University Chicago -
7. A Double-Blind, Randomized, Placebo-Controlled Trial Measuring the Effects of XXXX on C-Reactive Protein Levels in Patients with Risk Factors for Cardiovascular Disease.
8. An 18-week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Safety Study to Assess the Safety, Tolerability, and Bioefficacy of XXXX to Reduce C-Reactive Protein in Patients with a History of Atherosclerotic Coronary Artery Disease, Elevated C-Reactive Protein and Concurrent Treatment with XXXX.
9. Observer-Blinded, Randomized, Phase III Study to Investigate the Non-Inferiority of XXXX vs.
XXXX as Vaccines for Japanese Encephalitis in Healthy Subjects.
10. An Open-Label Pilot Study to Assess the Safety and Immune Effects of Dietary Supplementation with XXXX.
11. An Open-Label, Phase II Study of the Safety and Efficacy of XXXX in Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis.
12. A Randomized, Double-Blind, Placebo-Controlled, Phase III, Three-Arm Study of the Safety and Efficacy of XXXX in Patients with Idiopathic Pulmonary Fibrosis.
13. Effect of XXXX on Exacerbation Rate in Patients with COPD.
A 52-week, Phase III, Double-Blind Study with XXXX Once Daily Versus Placebo.
14. A Prospective, Randomized, Controlled Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the XXXX for the Treatment of Severe Emphysema.
15. A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety and Efficacy of XXXX in Subjects with Moderate to Severe Allergic Asthma.
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