Megha Parekh

Process and validate longitudinal clinical data for patients in Practice Better, integrating laboratory reports, genetic reports, vital signs, cardiovascular risk factors, and patient-reported outcomes. Analyze cardiovascular and longevity biomarkers, including lipid profiles, ApoB, HbA1c, blood pressure, BMI, and inflammatory markers, to identify trends and support patient risk assessments. Clean, standardize, and reconcile clinical records in Microsoft Excel, addressing missing values, duplicate entries, inconsistent units, and documentation discrepancies to improve data quality.

Clinical Data Associate at Evermint Health (2026-03 – Present)

• Process and validate longitudinal clinical data for patients in Practice Better, integrating laboratory reports, genetic reports, vital signs, cardiovascular risk factors, and patient-reported outcomes.
• Analyze cardiovascular and longevity biomarkers, including lipid profiles, ApoB, HbA1c, blood pressure, BMI, and inflammatory markers, to identify trends and support patient risk assessments.
• Clean, standardize, and reconcile clinical records in Microsoft Excel, addressing missing values, duplicate entries, inconsistent units, and documentation discrepancies to improve data quality.

Quality Assurance Associate at Sun Pharmaceuticals Ltd (2021-09 – 2023-08)

• Executed electronic Document Management System (eDMS) operations, including SOPs, Work Instructions (WIs), and batch records with GDP. Used Minitab for statistical analysis of process performance.
• Maintained vendor records in MasterControl QMS, ensuring data accuracy, system integration, and regulatory compliance.
• Performed routine QA activities including CAPA management and deviation tracking using TrackWise, cGMP-aligned document change order (DCO) requests, and review of environmental monitoring (EM) reports.
• Supported IQ/OQ/PQ and process validation, reviewing protocols, executed records, deviations, validation reports and FMEA-based risk assessments while ensuring ALCOA+ data integrity and GMP compliance.
• Engaged in quality team projects involving design control, out-of-specifications (OOS)/out-of-tolerance (OOT) calibrations and internal/external audits.

Regulatory Intern at Oscar Medical & Envision Scientific (2020-07 – 2021-08)

• Supported preparation, review, and maintenance of regulatory documentation for Class III medical devices, including drug-eluting stents, supporting compliance and market authorization activities.
• Compiled technical documentation and regulatory submission files for European and ASEAN markets, ensuring accuracy, completeness, and effective document control.
• Reviewed product labeling, Instructions for Use (IFUs), specifications, and supporting documentation for consistency with applicable regulatory and quality requirements.
• Collaborated with Quality Assurance, R&D, and Manufacturing teams to collect and organize documentation for regulatory submissions and post-approval changes.

Master of Science in Regulatory Affairs – Northeastern University (2023-09 – 2025-06)

Bachelor of Pharmacy in Pharmacy – UKA Tarsadia University (Maliba Pharmacy College) (2019-06 – 2023-03)