Kristina Goyal, Pharmd, Rac Email & Phone Number

Philadelphia, PA, US

Foster City, CA, US

Brentford, Middlesex, GB

Brentford, Middlesex, GB

Brentford, Middlesex, GB

• Led project team in the preparation and timely submission of a meeting request and briefing document for an FDA EOP2 meeting
• Collaborated with cross-functional team to submit a FTIH IND application ahead of timelines and manage FDA questions with an outcome of safe to proceed
• Contributed to content and strategy for INDs, CTAs, sBLAs, BLA Annual Report, and GRS
• Created an end-to-end process map for NDA, BLA, and MAA submissions to facilitate the simplification of written standards across all functional lines in Global Regulatory Affairs
• Conducted competitive intelligence searches and analyses to inform regulatory strategy

Silver Spring, MD, US

• Evaluated PSPs and PPSRs and discussed changes with Clinical Pharmacology reviewers
• Attended weekly Pediatric Review Committee (PeRC) meetings to understand how responses to sponsors regarding submitted PSPs and PPSRs are determined
• Researched pediatric familial hypercholesterolemia trial characteristics and compared to corresponding trials in adults to determine if extrapolation should be further explored
• Drafted a manuscript for an upcoming submission to the Journal of Clinical Pharmacology

Chapel Hill, NC, US

• Drafted regulatory source documentation for clinical trials through the UNC Institute for Global Health and Infectious Diseases to ensure study compliance with approved protocols
• Developed and led a Regulatory Affairs Mini-Course through the Resident Teaching Certificate Program, increasing student awareness of the pharmaceutical industry
• Participated in the informed consent process and attended an IRB meeting to learn about clinical trial site operations and regulations

Flemington, NJ, US

• Conducted Medication Use Evaluations (MUEs) to identify inappropriate medication prescribing patterns for improvement in future patient care
• Provided new medication education to inpatients regarding indication and side effects

Rockville, MD, US

• Counseled patients on proper medication usage and side effects to improve compliance
• Led anticoagulation, diabetes, and pain clinics to manage patients’ maintenance medications
• Performed immunizations such as Influenza, Hepatitis B, and Tdap vaccines

Pompton Plains, NJ, US

• Evaluated therapeutic regimens for appropriateness and suggested changes in medications
• Discussed home medications with newly admitted patients to provide continuity of care

Springfield Township, New Jersey, US

• Communicate with NJ Department of Environmental Protection (NJ DEP) after Notice of Violation to ensure compliance with regulations and draft correction plan
• Create a new IV transfer order form to adhere to NJ Board of Pharmacy regulations
• Build slide decks to train IV pharmacy staff on entering IV orders and generating reports

Edison, New Jersey, US

• Led group topic discussion on chronic maintenance treatment of pediatric Cystic Fibrosis
• Completed 30+ clinical interventions to improve medication regimens for patients
• Monitored up to 3 patients daily to assess their labs, vitals, medications, and clinical progress

Parsippany, New Jersey, US

• Assessed potential therapeutic claims to identify competitive positioning of a client product
• Created slide decks for internal staff training on client products and competitive landscape

Philadelphia, Pennsylvania, US

• Contacted doctors regarding patient prescriptions to reduce doctor call queue by 90%
• Suggested alternatives to doctors for certain prescriptions requiring prior authorizations
• Counseled 20+ patients on prescriptions, OTC selections, and a heart-healthy lifestyle

• Suggested dosing regimens for patients during trauma alerts and stroke codes
• Interviewed patients about home medications and compliance to prevent drug interactions

Summit, New Jersey, US

• Analyzed regulatory precedent to provide strategic recommendations to team members
• Evaluated timeline of previous Clinical Trial Application (CTA) drafts to identify key delays that may be resolved in the future
• Assessed landscape of products approved through expedited programs to help understand the growth of such approvals over the years, as research for a scholarly activity
• Reviewed and updated centralized database of FDA-approved hematology and oncology products to assess product attributes, clinical trials, and study designs
• Ensured compliance of Trial Master File (TMF) documents for health authority inspection

US

• Resolved an average of 15 technological issues per shift to assist students and faculty with various operating systems and software, such as Microsoft Office Suite

Deerfield, IL, US

• Resolved conflicts for patient issues such as insurance problems to enhance customer service
• Collaborated with healthcare team on refill reminders to improve patient compliance
• Maintained and prioritized work flow efficiently to decrease wait times to under 15 minutes

Summit, New Jersey, US

• Identified diseases lacking database search functions and contacted support for their addition
• Analyzed and tagged 2000+ abstracts by therapeutic area for faster access to information
• Discovered 5 new conference abstracts to include in Celgene’s “History Book” of clinical trials