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Submission Writer I


Source:
TIMESJOBS.COM
Location:
Secunderabad, Telangana
Date:
18-11-2016
Job Code:
58314373
Categories:
  • Biotechnology & Science
Applying for this job will take you to an external site
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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.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). To contribute to 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). 4. Actively participate in planning of data analyses and presentation to be used in CSRs. 5. Documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. 6. Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing. 7. Support the development of OSM through participating in OSM initiatives and other related activities. 8. Contribute to development of processes within OSM. 9. Fostering cross-functional communication to optimize feed-back and input towards high quality documents. 10. 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: 2-6

Requirements

Bio-Statistician | Clinical Research | Data Management/ Statistics | Quality Assurance/ Control
Applying for this job will take you to an external site

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