Ahanitha Ashok

acxy94@r.postjobfree.com +1-925-***-****

OBJECTIVE

Analytical and result-oriented individual Seeking for a competitive and challenging position that will enable to use my skills to the fullest.

SUMMARY

Currently pursuing Masters in Medical Product Development Management at San Jose State University and holding a Bachelor in Dental Surgery (India)

Strong regulatory background including current federal guidelines of Drugs/Device/Biologics, FDA/USDA regulations, ICH guidelines, Labeling, Promotional Protocols and updated Good Laboratory Practices and Good Clinical Practices

Sound knowledge in clinical development, regulatory affairs, 510k Submission, Trial Master Files statistics in clinical trials, bioinformatics

Sound knowledge in pharmacology, microbiology, general anatomy, biochemistry, general pathology, physiology including general medicine and surgery

Excellent Project Management Skills

Excellent interpersonal communication and time management skills.

Excellent hands on computer skills including Microsoft Office (Word, Excel, Power Point, Publisher, Outlook), Adobe Acrobat 9 Pro, MS Project

EDUCATION

MS Medical Product Development Management, San Jose State University, (June 2017)

Clinical Development, Regulatory Affairs (Drugs and Devices), Project Management, Finance and Management Accounting, Clinical Trials, People Management, Statistics in Clinical Trials.

Bachelor of Dental Surgery, Tamil Nadu Government Dental College. Chennai, India. (March 2008)

Pharmacology, Microbiology, General Anatomy, Biochemistry, General Pathology, Physiology, General Medicine and Surgery, Dental Subjects- Anatomy, Prosthodontics, Pedodontics, Orthodontics, Periodontics, Surgery, Conservative Dentistry

PROJECTS UNDERTAKEN

Project, SpermCheck Fertility device. Analyzed the difference in regulatory procedures for drugs and devices, Labeling and approval procedures for IVD devices. (April 2016- Present)

Project, Drug Harvoni, the first combination pill for treatment of Chronic Hepatitis C genotype 1 by Gilead. Researched on the drug’s FDA facts the patent extension, Label expansion, Role of Advisory Committee in Advertising and promoting materials and NCE exclusivity determination. Focused on how the manufacturers apply for 510 k submission and their ongoing studies for ION- 4 trials, which evaluate the treatment of genotype 1 or 4 chronic Hepatitis C patients who are co-infected with HIV (September 2015- January 2016)

Financial analysis of the pharmaceutical company Gilead. Analyzed their 10 k reports to find out their performance in the year 2015 compared to 2014

Alair Bronchial Thermoplasty - in the treatment of Bronchial Asthma (September 2015)

Bronchial Thermoplasty by Alair system (Asthmax Inc., Sunnyvale, CA) - first devise-based treatment approved by FDA

Researched on process to conduct clinical trials in different demographics to find out safety endpoints and effectiveness.

Studied clinical trials process conducted by the manufacturers for new emerging therapies for bronchial asthma

Outsourcing in Clinical research (November 2015)

Performed data analysis and researched on advantages and disadvantages of outsourcing clinical trials.

Documented insights on reasons behind outsourcing the clinical trials, problems faced by the participants in outsourced clinical trials and the ethical issues with globalization of clinical research

Ethics in Clinical Trials (December 2015)

Research paper that discussed ethical guidelines, role of IRB, IEC, data and safety monitoring board, statistical ethics, the alternate approaches for more ethical clinical trials, ethical dilemma and therapeutic misconception & solution to avoid it.

WORK EXPERIENCE

Dentist, O.K Dental Clinic, Virudhunagar, India Jan 2011- Apr 2012 (1 year 3 months)

Dentist, Adarsh Dental Clinic, Chennai, India. Mar 20007- May 2008 (1 year 3 months)

Dentist, Sudhakar Dental Clinic, Virudhunagar, India. May 2008 – Mar 2010 (1 year 11 months)

Internship, Tamil Nadu Government Dental College & Hospital, Chennai, India. Mar 2007 – Mar 2008

PROFESSIONAL MEMBERSHIP

RAPS

ACRP

Indian Dental Association (IDA), Chennai, India

ADDITIONAL INTERESTS

Best Paper Award for “Steroids In Oral Lesions”

National Seminar on Oral Medicine and Radiology (November 2007)

Best Paper Award for “Astute Clinician in the Making”

25th Tamil Nadu State Dental Conference (November 2007)

Best Paper Award for “Eye Witness”

Clinical Society Meeting (August 2007)

Best Paper Award for “Spit And Spot”

61st Indian Dental Conference (January 2008)

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