Rutgers University–New Brunswick

Regulatory Affairs Manager at GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare

Regulatory Affairs Manager

Pfizer

Regulatory Affairs Contractor - Marketed Products

- Analyzed and documented Abbreviated New Drug Applications that were affected by changes in the reference New Drug Application•	Categorized ANDAs and their bioequivalence discipline review outcomes to determine Generic Drug User Fee Act standards effects’ on approvals•	Summarized and presented the Office of Prescription Drug Promotion’s role and connection to agency and industry to the Office of Generic Drugs team •	Interpreted a recent guidance and its application to the industry during shadowing experience with OPDP professionals•	Explored and discussed Advisory Committee meetings involving pharmaceutical company sponsors, FDA and expert panelists and the outcomes

Office of Generic Drugs Extern

- Developed presentation for sales representatives to explain benefits of product •	Conducted competitive analyses by examining launch dates of upcoming products and highlighting differences among products such as indications, cost, and regimen•	Drafted materials to conduct market research •	Collaborated with the marketing team to review drafts and incorporate client comments on promotional pieces

RevHealth

Marketing Intern

- Designed promotional content directed towards healthcare professionals •	Created and presented disease state background summaries to upper management to prepare for client meetings•	Conducted clinical literature searches, competitive landscape analyses, and patient and healthcare professional insight mining to facilitate partnerships with various pharmaceutical industries•	Functioned as a promotional medical writer and incorporated client comments•	Evaluated and identified clinical data to support marketing efforts and drive strategic imperatives

Medical Writing Intern

- Analyzed and edited text and web based labels to ensure FDA requirements for labeling•	Compared labeling of different products to ensure compliance•	Collaborated with a multidisciplinary team of interns and colleagues to research and develop an idea for new products based on millennial perspectives•	Explored promotional material review committee meetings on promotional pieces ranging from direct to consumer ads to social media posts•	Compared marketing claims for product webpages with the internal claims database to ensure consistency and highlight discrepancies

Regulatory Assistant

- Communicated with patients to ensure proper adjudication and acquisition of medication• Collaborated with the pharmacists, interns, and technicians to ensure patient satisfaction• Prioritized important tasks such as inputting and filling of prescription, customer service, andinsurance resolution• Counseled patients on over-the-counter medication selections

Amar Ray