Company Name:HEALTH ARX TECHNOLOGIES PRIVATE LIMITED
Location:New Delhi, Delhi / NCR
Experience:2 – 7 years
Qualification:Doctorate :Any Doctorate
Job Description:Roles and Responsibilities
- To Participate in the process of protocol design and medical writing and review as appropriate in coordination with clinical strategy, medical operations and lab operations.
- Manage the writing, editing and reviewing of diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries and other medical/regulatory documents (including regulatory summary documents).
- Provides input to timelines for completion of clinical documents, and ensuring delivery of documents to meet the timelines.
- Develop, implement and manage templates & documentation format required for standardization of regulatory & clinical documentation to support development and registration activities.
- Serve as the primary medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory and scientific departments
- Reviews pertinent literature, evaluating its applicability, and incorporating the information into clinical documents.
- Ensures that all clinical documents are produced according to appropriate SOPs and business practices
Address:A-9,GROUND FLOOR AND FIRST FLOOR,FIEE COMPLEX,NEAR, C LAL CHOWK,OKHLA INDUSTRIAL AREA PHASE-2, NEW DE, LHI, NEW DELHI, Delhi, India