Hetna Pandya
Ahmedabad
Summary
Senior medical writer specializing in BA/BE and Phase-1 studies, with expertise in protocol writing for complex molecules and formulations including inhalation, nasal spray, infusion, and topical products. Proven track record in PK-PD studies, delivering high-quality documentation that meets regulatory standards. Strong ability to translate complex scientific concepts into clear, concise protocols. Committed to enhancing clinical research through precise and effective communication.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Medical Writer
Hetna
Ahmedabad
06.2022 - Current
- Specialized as senior medical writer in Phase 1 and complex bioavailability studies.
- Prepared regulatory documents for Pharmacokinetic-Pharmacodynamic and dose proportionality studies.
- Developed documentation for food effect studies and hospital site evaluations.
- Authored reports for inhalation, nasal spray, transdermal patch, and gel formulations.
- Produced detailed documents for rectal formulations and hormonal studies.
- Prepared regulatory submissions for infusion formulation studies to meet compliance standards.
Medical Writer
Axis Clinicals
Ahmedabad
07.2017 - 06.2018
- Prepared regulatory documents, including protocols and informed consent forms, for compliance with USFDA, EU, Health Canada, ANVISA, and Turkey regulations.
- Developed study protocols for complex designs, emphasizing steady state conditions and non-randomized studies.
- Created case report forms to support bioavailability and bioequivalence studies in line with international standards.
Medical Writer
Cliantha Research Limited
Ahmedabad
04.2016 - 07.2017
- Created BA/BE study protocols, informed consent documents, and case report forms for diverse designs, including crossover and double-blind studies.
- Collaborated with global clients to ensure adherence to regulatory requirements.
- Developed comprehensive documentation for various study methodologies, enhancing clarity and compliance.
- Engaged with international stakeholders to facilitate smooth regulatory processes across studies.
Research Associate
Accutest Research Laboratory
Ahmedabad
12.2015 - 04.2016
- Monitored clinical aspects of complex studies, including transdermal patches and vaginal formulations.
- Ensured compliance with global sponsors and regulatory inspections.
- Conducted quality checks on study documents to maintain accuracy and integrity.
Education
M.Pharm -
Gujarat Technological University
Ahmedabad06-2014
B.Pharm -
Gujarat Technological University
Ahmedabad06-2012
Skills
- MS Office and PDF
- Clinical research and documentation
- Protocol design and development
- Medical and scientific writing
- Regulatory compliance and writing
- Project management skills
- Effective communication strategies
- Stakeholder engagement techniques
- Team collaboration abilities
- Research methodologies expertise
- Therapeutic area knowledge
- Ethical standards adherence
- Literature review skills
- Complex information simplification
Certification
- Pharmacovigilance and medical writing certificate course by Gujarat Technological University
Total Work Experience
10 years
Personal Information
Nationality: Indian
Languages
- English
- Hindi
- Gujarati
Projects
365 Days
Accomplishments
- Invention Award at Veeda Clinical Research
- Received the Spotlight Award at Veeda Clinical Research for December 2022 and June 2023
References
References available upon request.
Timeline
Senior Medical Writer
Hetna
06.2022 - Current
Medical Writer
Axis Clinicals
07.2017 - 06.2018
Medical Writer
Cliantha Research Limited
04.2016 - 07.2017
Research Associate
Accutest Research Laboratory
12.2015 - 04.2016
M.Pharm -
Gujarat Technological University
B.Pharm -
Gujarat Technological University
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