Clinical Scientist/Validation Reporting & Technical Documentation - Mac-Chem Products - India
(2024-11)
- Reviewed medical and technical documentation for GxP compliance, ensuring accuracy, data integrity and alignment with ICH/GCP standards
- Prepared structured validation reports and scientific documentation aligning with regulatory expectations and supporting audit readiness
- Coordinated with stakeholders to maintain compliance in documentation workflows, reinforcing cross-functional collaboration and timely project deliverables
- Contributed to SOP development and technical documentation supporting clinical and validation processes, ensuring consistency with quality systems and enterprise policies
Clinical Writer/ Aggregate Reporting - Iqvia - Remote
(2024-08 - 2024-11)
- Drafted regulatory submission aggregate reports adhering to pharmacovigilance agreements, incorporating medical data review principles and ensuring compliance with ICH and GCP standards
- Coordinated with pharmacovigilance (PV) and medical affairs, maintaining version control and compliance while supporting medical data queries and closure workflows
- Supported medical affairs and pharmacovigilance teams by coordinating with stakeholders and HCPs to gather scientific data contributing to patient profile review and protocol deviation review activities
- Interpreted safety data from multiple sources, performed data visualization, and summarized clinical safety trends in Medical Review Summary reports
- Contributed to comment resolution and review workflows for regulated clinical and safety documentation, ensuring alignment with Clinical Operations, Data Management, and Project Management collaboration requirements
Clinical Writer / Validation Support - Merck - USA
(2023-08 - 2024-05)
- Analyzed and summarized project planning information, ensuring alignment with global regulatory requirements and meeting established deadlines
- Coordinated with vendors to confirm the proper application of methods, initiating necessary meetings to address compliance and documentation needs
- Supported validation and regulatory documentation (plans, reports, method qualification summaries) in a GxP environment, contributing to inspection-ready dossiers and adherence to ICH/GCP standards
- Worked within Veeva-based content workflows to manage document review, approval, and version control, ensuring accuracy and compliance
- Contributed to structured validation and technical documentation by summarizing methods, test results, and qualification activities, helping ensure documents were complete, well-structured, and aligned with cGMP/EHS and internal SOPs
Clinical Writer / Scientific Project Coordinator (Liaison) - Meyer Vitabiotics - India/UK
(2022-02 - 2023-06)
- Supported clinical trial coordination with internal stakeholders, investigators, and outsourced CRO teams, reinforcing Clinical Operations Collaboration and compliance with ICH/GCP
- Contributed to protocol discussions, site feasibility assessments, and patient enrollment planning, aligning with study design and eligibility review requirements
- Authored clinical and regulatory documents including protocols, investigator brochures, Module 2.5, Module 2.7, and related submission materials, ensuring accuracy and adherence to regulatory requirements
- Coordinated cross-functional input from Medical, Regulatory, Sales, CROs, and KOL to support document development and study execution, mirroring Data Management and Project Management collaboration
- Received and processed ICSRs from clinical trial, spontaneous, and published sources, supporting medical data review and patient profile review activities
- Supported safety reporting and patient narratives through scientific evidence review and document preparation, contributing to Medical Review Summary reports
- Managed procedural documents for Medical Affairs from authoring through compliance approval, ensuring alignment with enterprise SOPs and regulatory compliance
Upskilling & Career Transition - Career Break - US/India
(2020-03 - 2021-03)
Remained in the US during COVID-19 due to travel restrictions and flight cancellations. Focused on upskilling in medical writing and documentation during this period. Relocated to India in March 2021. Also worked briefly as a Visa Counsellor in Jan-Feb 2022 to support transition.
Liaison/ Chemist - VHS LLC - NY/NJ
(2017-12 - 2020-03)
- Developed and implemented regulatory strategies, ensuring compliance with applicable guidelines and timely submission of required documents
- Coordinated with healthcare professionals for product extensions and managed product development projects across multiple therapeutic areas, maintaining strict adherence to SOPs
- Conducted analytical testing using chromatography techniques, interpreted data within established guidelines, and contributed to regulatory filings and quality control processes
- Communicated technical and regulatory information to non-technical stakeholders in clear written form, supporting accurate documentation of product changes and quality milestones
PV Associate, Analyst & R&D Scientist, Pharmacist - Various Employers
(2001 - 2017)
PV Associate: ICSR, MedDRA coding, PBRER/PSUR for pharma products. Analyst & R&D Scientist: Analytical method validation, formulation, GMP documentation. Pharmacist: Patient safety, regulatory compliance, product dispensing.
