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Submission Writer I

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.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.Minimum requirementsMinimum requirements Masters with 1-3 years of relevant experience. PhD or degree in medicine (MBBS/MD or Alternative medicine) with 0-1 years of relevant experience. Fluent English (oral and written). 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes. Excellent communication skills (written, verbal, presentations) Operational knowledge of clinical trial reporting. Knowledge of biostatistics principles. Ability to prioritize and manage multiple demands and projects. Knowledge of and some experience in global registering of drugs (simple submissions). Knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). Ability to define and solve complex problems (Problemsolver ) Broad knowledge and future oriented perspective Proven track record in matrix environment Experience in contributing to global, cross functional projects. Global, cross-cultural perspective and customer orientation
Degree: MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: MBBS

Experience: 2-5


Data Management/ Statistics | Documentation/ Medical Writing
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