Syed Ikram Sharif
Scientific Communications | Medical Writer | Regulatory Submissions
- Role
- Senior Associate - Scientific Writing at Indegene
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Syed Ikram Sharif
Accomplished Medical writing professional having 7+years of expertise in Clinical Trials,…
Experience
Senior Associate - Scientific Writing
Dec 2024 — Present
Responsibilities1. Lead the writing, editing, and review of high-quality regulatory documents (e.g, clinical study reports [CSRs], protocols, investigator brochures [IBs], briefing documents, submission modules [Module 2.5, 2.7]2. Ensure compliance with ICH, FDA, EMA, and other global regulatory guidelines.3. Contribute to regulatory submission strategies (NDA, BLA, MAA, IND) and ensure timely delivery of high-quality documents.4. Maintain adherence to company SOPs, regulatory requirements, and industry best practices.5. Serve as the primary medical writing liaison between clinical, regulatory, biostatistics, and safety teams.6. Provide strategic input on document content, structure, and messaging.7. Supervise and mentor junior medical writers, ensuring consistency and quality across documents.8. Lead process improvement initiatives and develop templates/SOPs to enhance efficiency.9. Conduct peer reviews of regulatory documents for accuracy, clarity, and compliance.10. Interpret complex clinical data and present it clearly for regulatory and clinical audiences.11. Oversee multiple writing projects, ensuring deadlines are met without compromising quality.
Education
Tamil Nadu Dr. M.G.R. Medical University (TNMGRMU)
M Pharm, Pharmacology
2016 — 2018
THANTHAI ROEVER COLLEGE OF PHARMACY (Inst. Code - 138), PERAMBALUR
Diploma in Pharmacy, Pharmacy
2009 — 2011
Periyar College of Pharmaceutical Sciences
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2012 — 2015
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