Vijay Marati
Director of Clinical and Medical Affairs
- Role
- Director, Clinical and Medical Affairs at Illumina
- Location
- Tucson, AZ, US
- LinkedIn followers
- 500 followers
About Vijay Marati
Forward-thinking and accomplished leader with over 10+ years of experience in scientific/medical affairs, regulatory writing and clinical operations in medical device, IVD, and pharma sectors. Proficient in global regulatory, clinical, and quality requirements. Known for managing external vendors, establishing SOPs, and elevating operational efficiency. Expert in developing and disseminating strategic publications, and medical content for healthcare professionals, patients, and internal teams.
Experience
Director, Clinical and Medical Affairs
Aug 2021 — Present · Foster City, CA, US
Leader of medical writing group; responsible for clinical budgets and resource management to align with corporate goals; publications planning; managed clinical affairs process handled internal and external audits, and FDA BIMO inspection readiness- Managed a team medical/scientific writers, with accountability for performance management, career development, and resource planning; additionally qualified and oversaw external vendors- Authored clinical protocols, amendments, and reports (CSRs) in accordance with ICH guidelines and AMA style; prepared contents for package inserts, technical document summaries, quick reference guides, and Investigator\'s Brochures (IBs); managed publication planning, manuscript drafting, conference abstract submissions, and IVDR submission documents, including PEP, PER, CPR- Supported getting approvals for several companion diagnostics products in precision medicine in collaboration with pharma partners- Identified and addressed budget gaps by realigning roles and responsibilities, improving cross-functional coordination, and standardizing operational workflows- Handled regulatory agency responses as SME on clinical studies; prepared FDA pre-subs, regulatory submissions, and publications in collaboration with pharma partners- Built relationships with pharmaceutical partners and other KOLs to plan clinical utility studies and publications.
Education
University of Madras
Ph.D, Biochemistry
2001 — 2006
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