Senior Regulatory Operations Specialist

• Nov 2021 - Present

• Submit digital and print Global & US tactics (DTC/HCP) according to brand & FDA guidelines • Manage growth of regulatory operations associates • Maintain a library of references & collaborate with U.S. and Global librarians • Execute OPDP preparations and submissions • Attend and guide live reviews with MLRO • Review and provide feedback on SOWs • Own internal compliance work for teams by holding trainings, tracking server & brand platform access, and monitoring active and expiring tactics • Enforce industry standards for all MLR submissions per FDA/OPDP regulations • Generate current employee, tactic, and training reports for clients to maintain compliance Show less

Regulatory Operations Associate

• Nov 2020 - Nov 2021

•Worked with teams to prepare and submit (tag and link) projects into Veeva Vault, Zinc, and other client-specific platforms •Led Reg Ops trainings across multiple brands •Assisted in OPDP Binder preparations and submissions •Created and updated Reg Ops training decks for numerous brands •Provided recommendations and guidance on reference checks and submissions across teams •Maintained library of references •Communicated project updates and guidance on hotsheet meetings •Worked with teams to resolve reference and submission issues •Coordinated with business and creative operations directors to streamline training for new hires and current employees •Pulled most current PIs and ISIs, ran correction list, and sent out to teams to ensure consistency and accuracy •Coordinated with operations team to boost Reg Ops department growth Show less

Submissions Associate

• Jun 2019 - Nov 2020

Formerly Guidemark Health The final eye for the agency's submissions. Worked directly under the Editorial Team. • Tagged/Linked references and annotations accurately • Owned system (ie., Veeva Vault PromoMats) access and training compliance for agency • Coordinated with Editorial Team to prepare submissions-copy edits, cold reads, check changes, proofreading, fact-checks • Helped brand, write, and edit the company's first internal newsletter • Assisted Content Team with fact-checking and editing pieces • Ensured references were presented, highlighted, and appropriately cited in the correct format Show less

After-School Counselor

• Feb 2019 - May 2019

Supervised children from Kindergarten-8th grade during after-school hours (homework, dinner, activities). •Enhanced my verbal communication skills •Became an avid listener and mediator •Grew leadership skills •Applied problem-solving abilities Supervised children from Kindergarten-8th grade during after-school hours (homework, dinner, activities). •Enhanced my verbal communication skills •Became an avid listener and mediator •Grew leadership skills •Applied problem-solving abilities

Editor

• Mar 2018 - May 2019

Student editor for Elon University’s student-faculty-run environmental publication. Along with six other student editors, I chose submissions for publication, edited submissions, and finalized copy. We edited submissions as a team and individually. https://www.elon.edu/u/bft/sustainability/get-involved/student-opportunities/visions-magazine/ https://www.elon.edu/u/fa/sustainability/wp-content/uploads/sites/783/2019/08/Visions-2019.pdf Student editor for Elon University’s student-faculty-run environmental publication. Along with six other student editors, I chose submissions for publication, edited submissions, and finalized copy. We edited submissions as a team and individually. https://www.elon.edu/u/bft/sustainability/get-involved/student-opportunities/visions-magazine/ https://www.elon.edu/u/fa/sustainability/wp-content/uploads/sites/783/2019/08/Visions-2019.pdf

Public Relations Intern

• Jun 2018 - Aug 2018

• Assisted with creating weekly and monthly pitches for clients • Helped the team with creative brainstorming for events, pitches, etc. • Wrote and edited press releases, blog posts, pitches, etc. • Assisted with the execution of editor, tastemaker, and celebrity seeding • Researched blogs, magazines, and websites • Assisted with sample trafficking for clients • Assisted with monthly activity reports for clients • Helped maintain and keep media lists updated • Assisted with creating weekly and monthly pitches for clients • Helped the team with creative brainstorming for events, pitches, etc. • Wrote and edited press releases, blog posts, pitches, etc. • Assisted with the execution of editor, tastemaker, and celebrity seeding • Researched blogs, magazines, and websites • Assisted with sample trafficking for clients • Assisted with monthly activity reports for clients • Helped maintain and keep media lists updated

Waitress

• Jun 2015 - Feb 2016

Retail Assistant

• Sep 2011 - Apr 2012