Neepa Gaba

Clinical Scientist and Clinical Documentation Specialist with 10+ years of experience in pharma. Skilled in Medical Management Plan development, Medical Data Review Plan development, and Eligibility Review Plan development. Experienced in medical data review, data visualization, and authoring medical data queries.

Supported patient profile review, protocol deviation review, and Medical Review Summary report creation. Collaborated with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams to ensure compliance with ICH guidelines and Good Clinical Practices (GCP). Strong knowledge of regulatory documentation, safety data interpretation, and cross-functional collaboration across global teams.

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.

Master of Science - Pharmaceutical Sciences, Pharmaceutics and Drug Delivery - Northeastern University (2008) Boston, MA

Bachelor of Pharmacy - Pharmaceutical Sciences - Principal K.M. Kundnani College of Pharmacy (2001) Mumbai University