Heta Zaveri Email & Phone Number

Deerfield, Il

•Independently provide regulatory guidance and expertise to cross-functional team on multiple gastroenterology brands•Reviewed draft product labels, clinical science reports, protocols, and publications to provide high quality regulatory support on new product and indication launches•Consistently work cross-functionally to provide high quality, timely and decisive regulatory advice to commercial partners•In-depth knowledge of FDA regulations, policies and procedures as related to promotion and advertising•Manage submissions of promotion materials including request for advisory comments•Mentor and provide guidance to more junior regulatory personnel and interns •Created training materials for new employees and to improve consistency across regulatory reviewers•Lead recruitment and interview process for summer intern

Lake Forest, Il

Responsible for ensuring medical accuracy and compliance of marketing and sales training materials for Humira Rheumatology •Communicate medical recommendations regarding marketing and sales content while negotiating solutions for both the US and international markets •Collaborate with marketing, regulatory, and legal to produce compliant promotional material through multiple marketing avenues including television commercials and print materials. •Provide on-site medical review and analysis at photo shoots, speaker programs, patient video testimonials and commercials •Maintain an in-depth understanding of product knowledge, labeling, and relevant data for Humira and its competitors •Understand and keep current on the Office of Prescription Drug Promotion (OPDP) regulations and guidance documents and how they apply to drug advertising and promotion•Developed and lead a social media team to keep medical review current with marketing trends and opportunities via social media platforms •Develop and review safety documents for global promotional material with Abbott International•Lead medical reviewer for Humira Risk Management international initiatives and projects to fulfill European Medicines Agency requirement •Trained and mentored an Abbott employee for a cross-functional job trade program for which lead to a permanent position in Global Medical Review •Co-created and developed a Pharm D student rotational program in Abbott’s Global Medical Review department •Led and participated in a cross-functional competitive intelligence team at the American College of Rheumatology conference to gain market insight in 2011 and 2012 •Key participant and reviewer in 2012 and 2013 brand and tactical plans for Humira Rheumatology •Attend external and internal training sessions on Statistics in Healthcare, Drug Information, and Negotiation to Agreement

•Provide regulatory support for diabetes, acute care, hospital, and interventional cardiology brand teams for the review and approval of promotional materials and activities o Material examples include: websites, direct to consumer commercials, physician speaker programs, journal ads, exhibit materials, disease management programs, hospital programs, patient education material, core detail aids, computerized detail aids, formulary sheets, etc.•Understand and effectively communicate the FDA regulations and guidance documents and how they apply to the drug advertising and promotion process•Analyze and present FDA enforcement letters as they are published•Precept and mentor PharmD students•Provide education regarding practical implementation of the advertising regulations to regulatory colleagues•Provide and conduct training sessions as needed to other functional areas regarding FDA regulations for advertising and promotion•Participate in fellowship activities to increase knowledge about industry and drug development through presentations and meetings •Attend various external and internal training sessions regarding various topics including: Quality Decision Making, Insights Into Personal Effects, Integrated Marketing, and DDMAC Lucy Rose Training •Attended ASHP-Midyear 2009 to assist with recruiting and interviewing 2009 candidates and also presented research findings: “Examining social media: current practices, opportunities and risks associated with the evolving form of health communication.”

Counseled patients on prescription and over the counter medicationsAssisted with inventory management Performed general pharmacy intern duties which consisted of filling, entering, sending faxes, inventory, etcContacted healthcare providers and insurance companies in order to provide patients with quality care

Counseled patients on prescription and over the counter medicationsAssisted in medication dispensing processCollaborated with other healthcare professionals and third-party providers to deliver optimal patient care and servicePerformed general pharmacy duties and inventory managementClinical Rotations April-May 2009 Acute Care