Manokaran P
Technical Manager | Senior Medical Writer | EU MDR Clinical Evaluation (CER, CEP, PMCFP, PMCFER) | QMS| Regulatory & Clinical Documentation|
- Role
- Technical Manager, Medical Writer at HCLTech
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Manokaran P
Technical Manager | Senior Medical Writer | EU MDR Clinical Evaluation (CER, CEP, PMCFP, PMCFER)| QMS| Regulatory & Clinical Documentation|PROFILE SUMMARY:Senior Medical Writer & Technical Manager with 17+ years of experience in Clinical Evaluation (CER, CEP, PMCFP, and PMCFER) and EU MDR 2017/745 regulatory compliance. Expertise in systematic literature review, clinical evidence appraisal, and regulatory medical writing. Experienced in Quality Management Systems (QMS), CAPA/deviation management, and supporting global regulatory audits (USFDA, MHRA, TGA, Canada)—proven ability to deliver audit-ready documentation and lead cross-functional teams. CORE COMPETENCIES:Clinical Evaluation Plan (CEP)Clinical Evaluation Report (CER)PMCFP/PMCFER DocumentationEU MDR 2017/745 ComplianceSystematic Literature ReviewClinical Evidence AppraisalRegulatory Medical WritingQuality Management System (QMS)ISO13485 Quality Management SystemsCAPA/Deviation ManagementRegulatory Audit SupportSOP Development
Experience
Technical Manager, Medical Writer
Jan 2020 — Present
Senior Medical Writer & Technical Manager with 17+ years of experience in Clinical Evaluation (CER, CEP, PMCFP, and PMCFER) and EU MDR 2017/745 regulatory compliance. Expertise in systematic literature review, clinical evidence appraisal, and regulatory medical writing. Experienced in Quality Management Systems (QMS), CAPA/deviation management, and supporting global regulatory audits (USFDA, MHRA, TGA, Canada)—proven ability to deliver audit-ready documentation and lead cross-functional teams.
Education
KCSM Matriculation Higher Secondary School
SSLC (X)
M.S Pharmaceutical technology
M.S Pharmaceutical technology, M.S Pharmaceutical technology
2009 — 2011
KCSM Matriculation Higher Secondary School
High School Diploma
Vels College Of Pharmacy
Bachelor of Pharmacy
B.Pharmacy
B.Pharmacy, M.S Pharmaceutical Tech
2003 — 2007
Vinayaka Missions University
Master of Science, PHARMA TECHNOLOGY
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