1.Writes, reviews, and edits scientific manuscripts, clinical study reports, plan outlines, protocols,
documents for regulatory submissions (e.g. meeting packages, investigational new drug [INDs]
applications, sections of marketing applications [NDA/CTD]), investigator brochures,
posters, newsletters, or other clinical and regulatory documents .
2.Interprets non-clinical and clinical data in the preparation of various technical reports.
3.Performs on-line literature searches.
4.Leads project teams in drafting individual report specifications, medical writing, and coordination of data analysis.
5.Schedules and conducts peer and team quality control review for assigned projects.
6.Serves as primary functional representative on project teams.
7.Provides both in-house and outside consulting services.
8.Reviews all relevant documents and interacts with functional leader and project manager to develop a thorough understanding of project timelines.
9. Contributes to clinical protocol development.
10.Coordinates and leads project teams in drafting report specifications, medical writing, and coordination of data analysis.
11.Coordinates and leads the writing of technical documents for regulatory submissions (e.g. meeting packages, INDs, sections of NDA/CTD) .
12.Serves as an active mentor to one or more junior staff members.
13.Provides formal in-service training as requested by the project manager.
Education: BDS, MBBS, M.Pharm, M.Sc
Experience: 0 to 5 yrs
documents for regulatory submissions (e.g. meeting packages, investigational new drug [INDs]
applications, sections of marketing applications [NDA/CTD]), investigator brochures,
posters, newsletters, or other clinical and regulatory documents .
2.Interprets non-clinical and clinical data in the preparation of various technical reports.
3.Performs on-line literature searches.
4.Leads project teams in drafting individual report specifications, medical writing, and coordination of data analysis.
5.Schedules and conducts peer and team quality control review for assigned projects.
6.Serves as primary functional representative on project teams.
7.Provides both in-house and outside consulting services.
8.Reviews all relevant documents and interacts with functional leader and project manager to develop a thorough understanding of project timelines.
9. Contributes to clinical protocol development.
10.Coordinates and leads project teams in drafting report specifications, medical writing, and coordination of data analysis.
11.Coordinates and leads the writing of technical documents for regulatory submissions (e.g. meeting packages, INDs, sections of NDA/CTD) .
12.Serves as an active mentor to one or more junior staff members.
13.Provides formal in-service training as requested by the project manager.
Education: BDS, MBBS, M.Pharm, M.Sc
Experience: 0 to 5 yrs
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