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Manikanta K
Assistant Manager – Medical Writing
Medical Writing
Manikanta K is a Medical Writing professional with nearly 10 years of experience in authoring and reviewing regulatory and clinical documents for global submissions. He specializes in study protocols, clinical/bioanalytical study reports, IBs, ICDs, and IMPDs in alignment with ICH and international regulatory guidelines. Skilled in QC review, PK analysis, and cross-functional coordination, he has supported audits from DCGI, WHO, ANVISA, and USFDA while mentoring teams and ensuring high-quality, submission-ready deliverables.
FORMERLY AT
Syngene International Ltd
LOCATION
Bengaluru, Karnataka, India
AVAILABILITY
Full-time
Skills
BA/BE Documentation
Cross-functional Review Management
eCTD Documentation
ICH E3 CSRs
Phoenix
Phoenix 8.0
PK Data Analysis
Protocol & CSR Development
Protocol/CSR/IB Authoring
SOP Review
WinNonlin
Work Experience
Executive – Pharmacokinetics
Sun Pharmaceutical Industries Ltd., Baroda
August 2017 – January 2020
- Drafted and reviewed study protocols, CRFs, ICFs, and clinical study reports.
- Performed pharmacokinetic analysis using Phoenix 8.0, prepared QC documentation, and contributed to scientific advice documents and regulatory responses.
TECHNOLOGIES
Phoenix 8.0, PK Data Analysis, Protocol & CSR Development
Medical Writer (RA-I)
AXIS Clinicals Ltd., Hyderabad
February 2015 – July 2017
- Developed and reviewed BA/BE study protocols, volunteer sheets, and REMS for global submissions (USFDA, EU, TGA, TPD, ANVISA, emerging markets).
- Prepared CSRs as per ICH E3 guidelines and performed PK analysis using WinNonlin/Phoenix software.
- Coordinated with ethics committees and investigators during document review.
TECHNOLOGIES
WinNonlin, Phoenix, BA/BE Documentation, ICH E3 CSRs
