Regulatory Affairs Specialist

• Aug 2021 - Present

Regulatory Affairs Consultant

• May 2021 - Aug 2021

Worked as a Regulatory Affairs Consultant for Project ALS • Developed a successful approach and strategy for the compounding and delivery of an investigational new drug in the clinic for a Phase I first in human clinical trial under an initial IND for Amyotrophic Lateral Sclerosis (ALS) • Successfully contributed to Drug Product sections of IND; no FDA potential clinical hold issues or significant comments were received from the Division of Neurology Products to open this IND Worked as a Regulatory Affairs Consultant for Project ALS • Developed a successful approach and strategy for the compounding and delivery of an investigational new drug in the clinic for a Phase I first in human clinical trial under an initial IND for Amyotrophic Lateral Sclerosis (ALS) • Successfully contributed to Drug Product sections of IND; no FDA potential clinical hold issues or significant comments were received from the Division of Neurology Products to open this IND

Compounding Pharmacist

• Nov 2018 - Aug 2021

• Compounded medications into customized formulations including sterile products, customized flavored and concentrated suspensions, and topical delivery systems • Developed SOPs to ensure compliance with USP <795>, <797>, and <800> general chapters • Supervised students and technical staff in a busy compounding pharmacy • Compounded medications into customized formulations including sterile products, customized flavored and concentrated suspensions, and topical delivery systems • Developed SOPs to ensure compliance with USP <795>, <797>, and <800> general chapters • Supervised students and technical staff in a busy compounding pharmacy

Regulatory Affairs Intern

• Mar 2017 - Jul 2018

SCOPE: Worked alongside the director of regulatory affairs in preparing regulatory dossiers for FDA submissions. ORGANIZATIONAL IMPACT: * Prepared submissions that included pre-IND meeting requests, BLAs, DMFs, amendments, supplements, and annual reports for GeoVax’s HIV vaccine candidates in partnership with the director. * Selected to draft module 1-4 content in traditional CTD format and eCTD format. SCOPE: Worked alongside the director of regulatory affairs in preparing regulatory dossiers for FDA submissions. ORGANIZATIONAL IMPACT: * Prepared submissions that included pre-IND meeting requests, BLAs, DMFs, amendments, supplements, and annual reports for GeoVax’s HIV vaccine candidates in partnership with the director. * Selected to draft module 1-4 content in traditional CTD format and eCTD format.

Consultant Pharmacist

• 2012 - 2013

SCOPE: Brought on board as the initial consultant in Georgia for a genetic testing start-up company. Onboarded new pharmacist consultants as the company experienced significant growth. ORGANIZATIONAL IMPACT:  Partnered with physicians and staff; offered clinical interpretations and insights related to genetic cytochrome P450 enzyme polymorphisms. Worked alongside sales representatives and provided advisement and support. * Visited sites; offered clinical support and advised sales representatives. Educated sales staff prior to client meetings. * Clearly explained the science behind genetic tests and demonstrated how the results related to and could impact patients taking medications prescribed by a physician. Show less

Hospital Pharmacist

• 2001 - 2004

SCOPE: Adhered to quality standards while serving as an inpatient pharmacist at this university-based teaching hospital. ORGANIZATIONAL IMPACT: * Maintained accuracy in order entry, drug distribution, and therapeutic drug monitoring. * Collaborated with healthcare providers to ensure patients received optimal drug therapy. * Applied science behind the medication with a focus on achieving optimal drug therapy for each patient. SCOPE: Adhered to quality standards while serving as an inpatient pharmacist at this university-based teaching hospital. ORGANIZATIONAL IMPACT: * Maintained accuracy in order entry, drug distribution, and therapeutic drug monitoring. * Collaborated with healthcare providers to ensure patients received optimal drug therapy. * Applied science behind the medication with a focus on achieving optimal drug therapy for each patient.

Hospital Pharmacist

• 1998 - 2001

SCOPE: Met quality standards in inpatient pharmacy and IV room settings for this community hospital. Accurately performed order entry, drug distribution, and therapeutic drug monitoring. ORGANIZATIONAL IMPACT: * Worked in collaboration with healthcare staff to provide patients with optimal drug therapies. * Monitored and adjusted drug therapies based on patient responses. SCOPE: Met quality standards in inpatient pharmacy and IV room settings for this community hospital. Accurately performed order entry, drug distribution, and therapeutic drug monitoring. ORGANIZATIONAL IMPACT: * Worked in collaboration with healthcare staff to provide patients with optimal drug therapies. * Monitored and adjusted drug therapies based on patient responses.

Hospital Pharmacist

• 1994 - 1998

SCOPE: Worked primarily as an IV room pharmacist in a fast-paced environment. Gained in-depth experience in aseptic technique, including chemotherapy pediatrics, parenteral nutrition, and anesthesia. ORGANIZATIONAL IMPACT: * Aligned with quality standards in inpatient pharmacy and IV room settings for this community hospital. SCOPE: Worked primarily as an IV room pharmacist in a fast-paced environment. Gained in-depth experience in aseptic technique, including chemotherapy pediatrics, parenteral nutrition, and anesthesia. ORGANIZATIONAL IMPACT: * Aligned with quality standards in inpatient pharmacy and IV room settings for this community hospital.