Drug Safety Associate 2 @ Promoted to DSA 2: July 2013 - Business process optimization (BPO) manager facilitator - Coordinate and follow-up with Drug Safety action items - Manager meeting facilitator - ARISg SME - Argus SME - ARISg to Argus Data Migration - UAT - EDC experience - Created ARISg User Guide (DE conventions) - Created ARISg Study Drug Dosing Information - Case processing responsibilities (clinical trial, post-marketed, IST: full data entry, QC, narratives, issuing queries, submissions) - SAE reconciliation - DSA IST lead - Developed and managed Safety Management Plans (SMP) / SMP Template - Created company-wide backup paper AE CRF / SAE Supplemental Form From August 2009 to Present (6 years 5 months) Clinical QA / Regulatory Specialist @ - Coordinated review and revision of procedural documents and forms - Communicated with department heads regarding reviewing, updating, training, and formatting the final documents - Administrator for the learning and procedural management system (LMS) From March 2009 to November 2009 (9 months) Clinical Research Specialist (CRA II) @ - Individual full site management responsibilities - Monitor case report forms for completeness, legibility, and conformity to available source - Developed and maintained relationships with Investigators, research coordinators, and study progress of CRO’s - Works with PIs and study coordinators to ensure adherence to protocol, FDA, and GCP guidelines - Works with site staff to obtain IRB approval from central or local IRBs - Verify completeness of clinical and regulatory documents including IRB approvals and reports - Review clinical trial agreements and budgets until contracts are fully executed - Managed and designed monthly newsletters containing the progress of the trial From March 2008 to December 2008 (10 months) Compliance Specialist II / Regulatory Affairs @ (Previously A.P. Pharma) - Served as Training and Standard Operating Procedures Coordinator - Renewed, updated, and applied for company-wide licenses and permits - Coordinate clinical test material selection from supplier to approved clinical test sites - Reviewed and approved documentation in MasterControl® (EDMS) for controlled release per change order - Final review and signature for all Certificate of Analysis (COA) packages, which includes In-Vitro Release - Audited Laboratory Communication Forms (LCF) to ensure traceability between LCF’s, protocols, and COA’s - Reviewed and submitted regulatory submissions and FDA regulatory correspondence - Reviewed, approved, and released experimental protocols - Batch record review for clinical lot release statements - Managed Compliance Administrators (3 – mentorship and training) From February 2006 to March 2008 (2 years 2 months) QA Document Specialist II @ (Previously Microgenics Corporation) - Full document management responsibilities that pertain to Microgenics’ Process Guidelines and cGMP - Primary point assigned to the conception of part numbers for controlled parts, Bill of Materials, Item Masters and other manufacturing-related documents - Validation as related to streamlining of document control processes - Sole individual within my department repeatedly involved with internal audits - Generation and revision of company-wide documentation per Procedure Change Orders (PCO) - Dedicated to new and revised content of the Material Requirement Planning System (QAD) - Sole distributor and overall upkeep of broad database with over 22,000+ documents From March 2002 to February 2006 (4 years)

Kevin M. is skilled in: Regulatory Affairs, Clinical Research, Quality Assurance, Drug Safety, Drug Development, Pharmaceutical Industry, Sop, Clinical Development, Regulatory Submissions, CRO, FDA, Biotechnology, CTMS, Clinical Trials, Lifesciences