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无工作经验 -
本科 -
招1人 -
11-09 发布
职位描述
职位描述： Position Purpose:?The resource is responsible for supporting Labeling Managers by maintaining documentation in labeling systems so that SOP requirements are fulfilled. Maintenance of workflow management tools and mailboxes and associated technical support are also an essential part of the role.Primary Responsibilities:?Supports Labeling Managers by maintaining documentation in GDMS, PfLEET and other systems so that SOP requirements are fulfilled. Maintenance of workflow management tools and mailboxes.?Ad hoc support for labeling deliverables.?Proof-reading of labeling text.?System data integrity and quality checks.Technical Skill Requirements:?Knowledge of the principles and concepts of labeling.?Basic knowledge of key regulatory and labeling principles and local regulations?Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures?Fluency in English language important however multi-language skills are advantageous?Clear and effective written and verbal communications?Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverables?Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS AccessQualifications (i.e., preferred education, experience, attributes)?Life sciences, pharmacy graduate or equivalent (desirable); or equivalent relevant professional experience.?Some ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products)is preferred.?Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.?Demonstration of attention to detail and problem solving skills required.?Proven technical aptitude and ability to quickly learn new systems and tools. 职能类别： 医药技术研发管理人员
联系方式
上海浦东张江高科技园区科苑路88号，德国中心
公司信息
Indegene is a leading integrated scientific partner to global pharmaceutical and life sciences companies delivering a spectrum of marketing, medical, regulatory, training, and research & analytics services. Through an innovative and game changing business model, Indegene is growing rapidly across USA, Europe and the Emerging Markets. Indegene has a proven track record of delivery with 15 of the Top 20 global biopharmaceutical companies and has routinely won prestigious industry awards including Hermes, RX club, Marcom and Webby for medical marketing and training initiatives. Leveraging the depth of our scientific expertise, scale of operations, hybrid delivery model, global footprint and intellectual property, we deliver value across multiple dimensions including cost-effectiveness, ability to work with global teams and their local affiliates, and the ability to deploy cutting edge innovative platforms for R&D and marketing Our services include Promotional Medical Education and allied marketing services, MedComm, Medical affairs, Regulatory Writing, Training Solutions, Digital Strategy, Research and Analytics, Creative Production Services and Pack Management. We also have proprietary platforms and products called Phynx in the area of alternate channel for physician engagement, Optimax, in the area of patient adherence & compliance, MedEngage online platform for KOL engagements and TrialPedia a clinical trial analytics and benchmarking platforms.
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