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崗位職責(zé):

?Writes, reviews, and edits scientific manuscripts, clinical study reports, plan outlines, protocols, documents for regulatory submissions, investigator brochures, posters, newsletters, or other clinical and regulatory documents

?Interprets non-clinical and clinical data in the preparation of various technical reports

?Perform literature searches and reviews

?Leads project teams in drafting individual report specifications, medical writing, and coordination of data analysis

?Schedules and conducts peer and team quality control review for assigned projects

?Serves as primary functional representative on project teams

?Provides both in-house and outside consulting services

?Reviews all relevant documents and interacts with functional leader and project manager to develop a thorough understanding of project timelines

?Contributes to clinical protocol development

?Performs other tasks as directed by the line manager

任職要求:

?A post graduate degree from an accredited institution in Life Sciences or Health-related Sciences, or equivalent

?Science or medical related writing experience required

?Familiarity with medical terminology

?Experience using computerized systems (PC-Windows and MS Word)

?Excellent written, oral communication and presentation skills

?Fluent in English reading, writing and speaking

?Pharmaceutical company or CRO experience developing pharmaceutical drugs for human use (e.g. pre-clinical science, medical related writing, clinical trials management, monitoring, or as an investigator or study coordinator for clinical trials)

?Experience in clinical study design and protocol development/writing

?Knowledge of regulatory submissions requirements, ICH clinical study report writing guidelines

【主要負責(zé)FDA遞交，英語要求流利】