长沙招聘

职位描述：
此职位外派至顶尖外资药厂Medical Writing 全球化团队，限有海外留学背景者。
Tasks:
? Uses project management skills to track, review and ensure timely completion of high quality documents.
? Provides to the medical writer (located either locally or remotely) assigned to a writing project, all source documentation from the electronic archive needed to author the document (e.g. statistical table sets, reference documents, subject data listings, etc.).
? Act as a central resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners.
? Maintain departmentaland project-specific style guides to reflect new agreements and changes due to SOPs, WPs, and regulatory guidelines. Provide updates to all medical writers (internal and external) regarding style, format, and content decisions.
? Work with key interface partners to facilitate the completion of clinical study reports and their appendices. Ensure clinical documents adhere to global standards and are in accordance with electronic publishing Standards. Checks that study file components (eg, Investigator CV’s, protocol and amendments, sample case report form) needed for the writing of clinical research reports (CSRs) are checked into the electronic archive (eg, eDMS) on a timely basis (i.e. based on agreed upon timelines for a writing project) and meet all global standards and regulatory requirements for format (eg, heading styles,language, accuracy).
? Proofreads, reformats and edits document text, as required, to ensure that all documents for a writing project meet all requirements for formatting (e.g. styles, fonts, etc.) prior to final QC, compilation and publishing. Reviews and performs QC checks of all documents and appendices to ensure consistency between and within documents.
? Assist scientific medical writers in the review of protocols and clinical study reports to ensure that methods are clearly presented, data categories are clear, and terminology is consistent.
? Manages the review and approval of documents in the document management system using standard procedures. Transfers clinical study documents from the individual study files into the electronic archive used to compile the final medical documents.
? Ensures that all team members have the required document management and review tool training required to review, approve and sign documents and trains them if necessary.

Requires:
?Master’s degree or equivalent, Bio-related (Biochemistry for example), Pharmacy, Nutrition, Chemical engineering, information management, library management related in Oversees education
?The incumbent should have familiarity with clinical research, statistics, and regulatory guidances, standards and requirements pertaining to regulatory medical writing world wide (eg ICH, FDA,
EMEA).
?The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards.
?The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.
?The incumbent must be a skilled user of word processing applications
？Good English proficiency, as it is going to be a truly global team environment 举报 分享

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