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Kalaiselvan Reddy
Manager – Medical Writing, Pharmacokinetics & Clinical Trials
Manager – Medical Writing, Pharmacokinetics & Clinical Trials
Clinical Research and Medical Writing professional with 12+ years of experience in pharmacokinetics, bioavailability/bioequivalence (BA/BE) studies, and global clinical trial operations across Phase I–IV and post-marketing surveillance. Expertise in protocol development, CSR writing, regulatory submissions (CTD modules), and handling PK/PD data analysis using Phoenix WinNonlin. Proven track record of managing multicenter clinical studies, leading cross-functional teams, and ensuring compliance with international regulatory guidelines (USFDA, MHRA, ANVISA, WHO, TGA, CDSCO). Experienced in partnering with CROs, overseeing audits and inspections, and delivering high-quality clinical and regulatory documentation to support product development and approvals.
FORMERLY AT
Torrent Pharmaceuticals Ltd.
LOCATION
Ahmedabad
AVAILABILITY
Full Time
Skills
CTD Authoring/Publishing Tools
CTD/ICH-E3 Documentation Tools
Data Management & Reporting Tools
eCRF/EDC
eCRF/EDC & Data Management Systems
eCRF/EDC Platforms
IVIVC Modeling
MS Office
Phoenix WinNonlin
Phoenix WinNonlin (PK/PD)
QA/Audit Tracking Systems
Work Experience
Manager – Medical Writing, Pharmacokinetics & Clinical Trials
Torrent Pharmaceuticals Ltd.
Jun 2014 – Present
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Lead a multidisciplinary team (medical writers, PK scientists, trial coordinators) to execute clinical studies and BA/BE programs.
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Design/oversee Phase I–IV clinical trials and PK studies; author protocols, CRFs, IBs, ICFs, and CSRs per ICH-E3.
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Manage multicentric trials from feasibility to closeout; coordinate BE NOC, CTRI, DCGI, Import License submissions and HA queries.
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Drive PK data analysis, IVIVC evaluation, and interpretation to support formulation optimization; govern SOPs and vendor CROs.
TECHNOLOGIES
Phoenix WinNonlin (PK/PD), IVIVC Modeling, eCRF/EDC & Data Management Systems, CTD/ICH-E3 Documentation Tools, MS Office
Manager – Clinical Research
Wockhardt Ltd.
May 2008 – Jun 2014
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Directed end-to-end Phase I–IV trials and BA/BE studies; authored protocols, CSRs, CTD (Modules 2.5, 2.7, 5).
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Led CRO oversight, facility setup documentation, and submissions; performed PK/PD analyses and IVIVC using Phoenix WinNonlin.
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Conducted audits/inspections (USFDA, MHRA, ANVISA, WHO); acted as sponsor monitor ensuring GCP compliance and data integrity.
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Managed 250+ pivotal studies across multiple TAs for global filings.
TECHNOLOGIES
Phoenix WinNonlin, eCRF/EDC Platforms, CTD Authoring/Publishing Tools, QA/Audit Tracking Systems, MS Office
Manager – BA/BE Studies
Accutest Research Laboratories
Aug 2007 – May 2008
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Designed BA/BE protocols, CRFs, ICFs; oversaw clinical data capture, bioanalytical verification, and final reports.
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Served as SPOC for sponsors on study progress, AE reporting, and compliance.
TECHNOLOGIES
Phoenix WinNonlin, eCRF/EDC, Data Management & Reporting Tools, MS Office
