Experience

Agios Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Associate Manager, Regulatory Affairs Strategy

  • Apr 2022 - Present

  - Act as regulatory representative on early and late phase clinical studies, ensuring compliant execution of trials - Prepare and coordinate regulatory submissions (ie CTAs, formal meeting documentation, life-cycle management submissions, etc.); support preparations and submission of INDs and marketing applications - Support and organize preparations for Health Authoring meetings and teleconferences - Assist in the development and execution of global regulatory strategy for long-term… Show more - Act as regulatory representative on early and late phase clinical studies, ensuring compliant execution of trials - Prepare and coordinate regulatory submissions (ie CTAs, formal meeting documentation, life-cycle management submissions, etc.); support preparations and submission of INDs and marketing applications - Support and organize preparations for Health Authoring meetings and teleconferences - Assist in the development and execution of global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs - Work within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations Show less



Reata Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Senior Specialist, Regulatory Affairs Development Strategy

  • Apr 2021 - Apr 2022

  Plano, Texas, United States - Assist with IR response submissions - Assist with other applicable NDA submissions - Responsible for IND maintenance submissions (safety reports, protocol amendments, investigator amendments, etc.) - Work closely with the GRL, assist in the development and revision of regulatory strategies for assigned project(s) - Support the tactical execution of regulatory strategies, including working closely with the Regulatory team and development teams to prepare regulatory plans and… Show more - Assist with IR response submissions - Assist with other applicable NDA submissions - Responsible for IND maintenance submissions (safety reports, protocol amendments, investigator amendments, etc.) - Work closely with the GRL, assist in the development and revision of regulatory strategies for assigned project(s) - Support the tactical execution of regulatory strategies, including working closely with the Regulatory team and development teams to prepare regulatory plans and submission preparation - Assist in the preparation for meetings with global health authorities

• Coordinator, Regulatory Affairs Submission Management

  • May 2020 - Apr 2021

  Plano, Texas, United States - Played an active role in completing the company's first NDA - Responsible for preparing safety submissions to submit to multiple INDs - Provided coordination, prioritization and tracking of regulatory activities - Managed not only traditional regulatory publishing, but intra-regulatory management of submission plans (timelines, resource plans) and medical writing resources - Fostered strong communication and interaction between other teams within Global Regulatory Affairs such as… Show more - Played an active role in completing the company's first NDA - Responsible for preparing safety submissions to submit to multiple INDs - Provided coordination, prioritization and tracking of regulatory activities - Managed not only traditional regulatory publishing, but intra-regulatory management of submission plans (timelines, resource plans) and medical writing resources - Fostered strong communication and interaction between other teams within Global Regulatory Affairs such as Development Strategy, CMC, Commercial and Operations in order to facilitate timely problem solving and maintenance of items - Actively partnered with other regulatory teams to facilitate development of detailed submission plans, writing/QC resource assignments, and publishing scheduling - Ensured communication and tracking of plan within regulatory

• Coordinator, Regulatory Affairs

  • Sep 2019 - May 2020

  Plano, Texas - Maintained a working knowledge of US pharmaceuticals - Compiled documents for product information files and regulatory submissions for global product compliance - Provided support for regulatory agency submissions - Assisted in the maintenance of FDA submissions - Prepared documents for submission to regulatory agencies - Utilized Veeva software for document management



Texas Digestive Disease Consultants

• United States
• Medical Practices
• 100 - 200 Employee

• Clinical Regulatory Assistant

  • Apr 2019 - Sep 2019

  Southlake, TX - Compiled and prepare materials for submission to regulatory agencies as necessary for study start up, study maintenance and continuing review - Reviewed clinical protocols to ensure collection of data needed for regulatory submissions - Participated in internal and external (CRO, Sponsor and FDA) audits - Reviewed adverse drug reactions and file all related reports in accordance with regulatory agency guidelines - Assisted research coordinators in identifying and submitting… Show more - Compiled and prepare materials for submission to regulatory agencies as necessary for study start up, study maintenance and continuing review - Reviewed clinical protocols to ensure collection of data needed for regulatory submissions - Participated in internal and external (CRO, Sponsor and FDA) audits - Reviewed adverse drug reactions and file all related reports in accordance with regulatory agency guidelines - Assisted research coordinators in identifying and submitting protocol deviations - Maintained each Investigator Site File within the Clinical Trial Management System for 60+ studies - Maintained communication with the sponsor, CRO, investigators and research staff - Demonstrated understanding of GCP, FDA, and other relevant guidelines Show less



DAVA Oncology

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Trial Specialist

  • Sep 2018 - Apr 2019

  Dallas, Texas • Responsible for maintaining accurate communication regarding protocol amendments, eligibility criteria, and patient accrual for 50+ US sites. • Experience with Phase I, Phase II and Phase III trials • Assisted in site selection and enrollment processes for Phase I and Phase III clinical trials including obtaining CDAs and FQs • Developed regional site communication strategies on a weekly to monthly basis • Developed patient facing brochures for investigators • Proficient in… Show more • Responsible for maintaining accurate communication regarding protocol amendments, eligibility criteria, and patient accrual for 50+ US sites. • Experience with Phase I, Phase II and Phase III trials • Assisted in site selection and enrollment processes for Phase I and Phase III clinical trials including obtaining CDAs and FQs • Developed regional site communication strategies on a weekly to monthly basis • Developed patient facing brochures for investigators • Proficient in sponsor specific EDC systems • Maintained professional and engaging relationships with all parties involved in the trial • Analyzed the competitive landscape for competing drugs and/or trials Show less



San Antonio Fire Department

• Student Researcher

  • Feb 2018 - Dec 2018

  San Antonio, TX • Developed the study design while collaborating with senior staff • Submitted all IRB documents • Became familiar with current and previous research related to pre-hospital pediatric pain management • Conducted a retrospective chart review study to locate all eligible data • Built and maintained a database with all data collected • Conducted simple and complex analyses using SAS • Maintained clear communication with all investigators throughout the study • Compiled the… Show more • Developed the study design while collaborating with senior staff • Submitted all IRB documents • Became familiar with current and previous research related to pre-hospital pediatric pain management • Conducted a retrospective chart review study to locate all eligible data • Built and maintained a database with all data collected • Conducted simple and complex analyses using SAS • Maintained clear communication with all investigators throughout the study • Compiled the results into a written manuscript Show less



CHRISTUS Santa Rosa

• United States
• 200 - 300 Employee

• Exercise Physiologist

  • Dec 2014 - Aug 2018

  New Braunfels, TX • Served as Lead Clinical Instructor for Cardiac Rehab internship program, supervising up to 4 interns at a time while managing schedules, daily tasks and evaluations • Assisted the Cardiac Rehab Action Registry quality team in improving physician referral compliance by more than 40% • Entered all pre and post outcomes data for more than 200 patients annually. Managed and analyzed data in excel to monitor for improvements during the course of the program • Produced summary tables and… Show more • Served as Lead Clinical Instructor for Cardiac Rehab internship program, supervising up to 4 interns at a time while managing schedules, daily tasks and evaluations • Assisted the Cardiac Rehab Action Registry quality team in improving physician referral compliance by more than 40% • Entered all pre and post outcomes data for more than 200 patients annually. Managed and analyzed data in excel to monitor for improvements during the course of the program • Produced summary tables and descriptions and present at quarterly meeting for clinicians and medical directors • Conducted patient evaluations in both inpatient and outpatient settings • Designed exercise programs for each Phase I, Phase II and Phase III cardiac and pulmonary patient • Demonstrated proficiency in EKG interpretation and symptom management • Delivered routine educational seminars for patients and their families. • Maintained clear communication with referring physicians as well as on-site physicians regarding patient management Show less



Central Texas Medical Center

• United States
• Hospitals and Health Care
• 100 - 200 Employee

• Exercise Physiologist

  • May 2014 - Nov 2014

  San Marcos, TX • Utilized knowledge of evidence-based best practices and apply appropriately to each patient • Maintained a positive team working environment • Maintained professional communication between team members and corresponding physicians