Sindhura V
Professional Summary
Medical Writer with 5+ years of experience delivering regulatory submissions, clinical documentation, and GMP compliance reports for leading CROs in the pharmaceutical and biotech space. Specializes in authoring IND, NDA, BLA, and EMA dossiers, clinical study reports, CMC Module 3 documentation, and investigator brochures that have supported multiple FDA and EMA approvals. Experienced working across oncology, biologics, biosimilars, and orphan drug programs, synthesizing biostatistical outputs, safety datasets, and manufacturing data into audit-ready documents. Proficient in Veeva Vault CTMS/eTMF, Medidata Rave, Oracle Clinical, and CDISC SDTM/ADaM standards, with hands-on application of ICH-GCP, 21 CFR Parts 210/211, and MedDRA coding across both FDA and EMA submission frameworks. Recognized for first-submission CSR approvals, zero-deficiency EMA inspection outcomes, and cross-functional review resolution within 48-hour turnaround windows.
Technical Skills
Work Experience
- Authored IND, NDA, BLA, and EMA dossier packages that contributed to three successful FDA approvals, delivering all documentation ahead of sponsor-mandated timelines.
- Developed CMC documentation (Module 3 – Quality) covering raw material specifications, in-process controls, and stability data for biologics and biosimilar programs, resulting in zero deficiencies noted across two EMA inspections.
- Drafted clinical study reports by integrating biostatistical tables, figures, and listings, producing audit-ready CSRs that passed first-submission regulatory review across four distinct therapeutic areas.
- Prepared manufacturing SOPs and batch records aligned with cGMP requirements, covering 12 production workflows with full ALCOA+ traceability across all batch documentation.
- Authored deviation and CAPA documentation for 15 quality events, ensuring complete traceability, root-cause analysis, and timely effectiveness checks in accordance with 21 CFR Parts 210/211.
- Developed pharmacovigilance documentation including safety narratives and risk management plans, maintaining full alignment with MedDRA coding conventions and EMA reporting standards.
- Created plain language summaries and patient-facing trial materials achieving Flesch Readability scores above 70 and full compliance with regulatory transparency requirements.
- Performed quality control reviews of manufacturing and clinical documents, sustaining audit-ready status with zero corrective actions raised during three sponsor inspections.
- Drafted clinical study protocols and protocol amendments across five biotech trials, ensuring full alignment with ICH-GCP standards and FDA/EMA submission requirements.
- Authored clinical study reports in oncology by synthesizing biostatistical TFLs from biostatistics and data management teams, achieving first-submission regulatory approval on all three oncology CSRs.
- Developed regulatory submission packages for INDs, NDAs, BLAs, and EMA dossiers supporting two orphan drug approvals, delivering complete documentation sets ahead of agreed sponsor milestones.
- Conducted systematic literature reviews across PubMed, Embase, and MEDLINE, integrating evidence into regulatory dossiers and scientific publications with zero citation errors across more than 200 references.
- Prepared investigator brochures and patient narratives, managing end-to-end document workflows through Veeva Vault RIM/eTMF with zero deviations recorded across the review lifecycle.
- Authored scientific manuscripts, conference abstracts, and poster presentations contributing to four peer-reviewed journal articles and three biotech conference proceedings.
- Backed pharmacovigilance documentation by drafting ICSR safety narratives and risk management plans coded to MedDRA standards and aligned with EMA reporting requirements.
- Performed quality control reviews of clinical and regulatory documents, maintaining audit-ready status with zero corrective actions required during all sponsor inspections across the engagement.
Education
Certifications
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