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 medicalwriting
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.
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. Fluent English (oral and written). HYDERABAD ONLY: Masters with 3-5 years of relevant experience. PhD or degree in medicine (MBBS/MD or Alternative medicine) with 1-3 years of relevant experience 2 years medicalwriting experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medicalwriting processes. Excellent communication skills (written, verbal, presentations) Operational knowledge of clinical trial reporting. Very good understanding of biostatistics principles. Ability to prioritize and manage multiple demands and projects. Good 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 (Problem-solver) Broad knowledge and future oriented perspective Proven track record in matrix environment Experience in contributing to global, cross functional projects.
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. Fluent English (oral and written). HYDERABAD ONLY: Masters with 3-5 years of relevant experience. PhD or degree in medicine (MBBS/MD or Alternative medicine) with 1-3 years of relevant experience 2 years medicalwriting experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medicalwriting processes. Excellent communication skills (written, verbal, presentations) Operational knowledge of clinical trial reporting. Very good understanding of biostatistics principles. Ability to prioritize and manage multiple demands and projects. Good 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 (Problem-solver) Broad knowledge and future oriented perspective Proven track record in matrix environment Experience in contributing to global, cross functional projects.
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