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Submission Writer

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

To write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To manage the production of other documentation via outsourcing. Can Coach/mentor less experienced submission writers.1. To author, review and independently manage high quality clinical and safety documents non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registry Database (CTRD), Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR). 2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in OSM. 3. Core member of Clinical Trial Team (CTT)/ participate in Safety Management Team (SMT). 4. Actively participate in planning of data analyses and presentation to be used in CSRs. 5. Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. 6. May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents. 7. Act as liaison between CTTs, CSTs and publishing teams to ensure timely delivery of final documents for publishing. 8. Support the development of OSM through participating in OSM initiatives and other related activities. 9. Contribute to development of processes within OSM. May contribute to cross-functional initiatives. 10. Fostering cross-functional communication to optimize feed-back and input towards high quality documents. 11. Maintain audit, SOP and training compliance.
Degree: M.Pharm. (Pharmacy) | MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 3-5


Clinical Research | Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
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