Description

A Top MNC is currently hiring Medical Writer for Mumbai location on their Direct Payroll. Role -Regulatory Medical Writer Experience 4 - 11 years of experience in Medical Writing domain. Location: - Mumbai Job Description Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. 1. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. 2. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. 3. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. 4. Share project timelines amongst the study team for the development of document. 5. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. 6. Review statistical analysis plans and table/figure/listing, when required. 7. Ensure uniformity and consistency in the scientific content of the regulatory documents. Salary Upto 17LPA. Interested Candidate drop their cv's on [email protected]

Role and Responsibilities

• A Top MNC is currently hiring Medical Writer for Mumbai location on their Direct Payroll. Role -Regulatory Medical Writer Experience 4 - 11 years of experience in Medical Writing domain. Location: - Mumbai Job Description Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. 1. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. 2. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. 3. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. 4. Share project timelines amongst the study team for the development of document. 5. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. 6. Review statistical analysis plans and table/figure/listing, when required. 7. Ensure uniformity and consistency in the scientific content of the regulatory documents. Salary Upto 17LPA. Interested Candidate drop their cv's on [email protected]