Bharathi Raja

About Bharathi Raja

Writes, review and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports (CEP/CERs), and PMCF Plans/Reports, SSCPs, Regulatory Responses and other related documentation. • Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations and maintains thorough knowledge of assigned products. • Collaborates with team members/cross-functional teams and stakeholders in planning for and supporting CER related projects and processes. • Supports additional clinical, regulatory, quality and engineering related deliverable as assigned. • Involves in responses to complex queries such as those issued by notified bodies and stakeholders. • Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance’s (ISO, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents).

Experience

1. Technical Lead - Senior Medical Writer - Clinical Evaluation Reports

   HCLTech

   Jan 2023 — Present · Chennai, IN

Education

• Bharathidasan University

  M.Sc Biochemistry

• Anna University

  Ph.D

• Periyar University

  M.Phil Biotechnology

• Bharathidasan University

  B.Sc Biochemistry

• Advanced Innovation Group Pro Excellence (AIGPE)

  Lean Six Sigma Green Belt Certification

• James Lind Institute

  Advanced PG Diploma in Clinical Research and Medical Writing (APGDCR-MW)

  2019