Megha Swamy
Bengaluru
Summary
Detail-oriented and result-driven Document Quality Control (QC) Reviewer with over 10 years of progressive experience in the CRO industry, specializing in clinical and regulatory document QC across multiple therapeutic areas. Highly adept at managing complex document reviews, mentoring junior QC staff and collaborating with cross-functional teams including medical writing and regulatory affairs. Known for the ability to work effectively under pressure, maintain focus on quality and timelines and adapt quickly to evolving project needs. Detail-focused Document Reviewer recognized for highly productive and efficient task completion. Skilled in legal document analysis, data management and compliance verification. Excel in time management, critical thinking and communication, ensuring thorough examination and organization of complex documentation. Committed to maintaining confidentiality and integrity in all aspects of work.
Overview
12
12
years of professional experience
Work History
Senior Scientific Document Reviewer I
MMS Holdings Inc
Bengaluru
11.2018 - Current
- Perform high-level QC of complex clinical and regulatory documents including but not limited to: Clinical Study Reports (CSRs); Protocols; Investigator Brochures (IBs); Protocols, Patient Narratives; Clinical Evaluation Reports (CERs); lay summaries; Clinical Modules 2 and 3 documents, Non-clinical documents, Investigational New Drug (IND) Applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), briefing packages for regulatory agency meetings/advice (briefing documents, response to questions (RTQs), informed consent form (ICF), Risk management plan (RMP)
- Experience in working with templates, toolbars, and formatting tools.
- Ensure 100% accuracy, consistency, and compliance with templates, SOPs, and style guides.
- Adhering to QC checklists and documentation standards.
- Familiarity with ICH, GCP, EMA, FDA, and other global regulatory agency standards.
- Familiarity with various therapeutic areas (eg, oncology, cardiology, infectious diseases, obesity, CNS).
- Collaborate with medical writers, regulatory affairs, and biostatisticians to ensure document accuracy.
- 100+ clinical and regulatory documents QC-reviewed with successful submissions across multiple regulatory bodies (FDA, EMA
- Serve as Project Lead for various client projects and submission deliverables, responsible for timelines and quality assurance.
- Lead initiatives to automate or semi-automate repetitive QC tasks.
- Train and mentor junior reviewers, provided document-specific training.
- Manage version tracking for iterative document reviews.
- Interact with sponsors and regulatory affairs teams to align QC expectations.
- Provide guidance on interpreting regulatory guidelines in QC context
- Experience in managing documents uploaded in Veeva Vault/Veeva RIM.
- Clear written and verbal communication with cross-functional teams.
- Experience in drafting patient narratives.
- Adequate skill on Adobe illustrator application for graphic creation.
Associate QC Lead
Valuepoint Knowledgeworks
Bengaluru
10.2017 - 11.2018
- Led the QC team, managing workflows and ensuring process efficiency
- Conducted root cause analysis to address client concerns
- Ensured quality deliverables through content analysis and context clarification
- Performed monthly audits and prepared performance reports for MBR meetings
Sr. Scientific Analyst
Molecular Connections Pvt Ltd
Bengaluru
04.2014 - 05.2017
- Scientific data mining, data analysis & management, curation and, QC from peer-reviewed journals/scientific publications; to construct databases using a software tool
- Managed a team of curators, trained and mentored new hires, and, ensured timely delivery of high-quality project targets while enhancing team productivity
Education
Master of Science - Biotechnology
Vellore institute of technology (Autonomous)
06.2013
Bachelor of Science - Biotechnology
MS RAMAIAH College of arts, science, and commerce
06.2011
Skills
- Advanced Document QC
- Regulatory Guidelines
- QC Checklists
- SOP compliance
- Clinical Data Verification
- Cross-Referencing
- Patient Narrative writing
- Consistency checks
- MS Office
- Veeva Vault
- SharePoint
- Adobe Acrobat
- Adobe Illustrator
- Cloud PC
- Data interpretation
- Client POC
- Document-specific training
- IND/NDA submissions
- Strong interpersonal skills
- Strong communication skills
- Team Leadership
- Mentoring
- Adaptability
- Problem Solving
- Cross-functional communication
- Time Management
- Regulatory compliance
- Clinical document review
- Version tracking
- Cross-functional collaboration
- Attention to detail
- Clear communication
- Document quality control
- Multitasking capacity
Hobbies and Interests
- Music
- Movies
- Travel
- Art
Languages
- English
- Hindi
- Tamil
Timeline
Senior Scientific Document Reviewer I
MMS Holdings Inc
11.2018 - Current
Associate QC Lead
Valuepoint Knowledgeworks
10.2017 - 11.2018
Sr. Scientific Analyst
Molecular Connections Pvt Ltd
04.2014 - 05.2017
Master of Science - Biotechnology
Vellore institute of technology (Autonomous)
Bachelor of Science - Biotechnology
MS RAMAIAH College of arts, science, and commerce