職位描述
生物醫(yī)學(xué)編輯臨床醫(yī)學(xué)編輯MEDICAL WRITERCTDS
Key accountabilities:
? Leads the Medical Writing effort for local requirements in a global, priority program
? Independently leads the MW deliverables for complex global programs
? Acts as the Lead Writer/oversight for clinical sections of eCTDs for Chinese market approval
? Oversees work of internal and/or external writers (consultants, contractors and vendors, depending on operating model)
? Attends governance meetings e.g. for protocols
? No direct people management
? Leads the Medical Writing effort for local requirements in a global, priority program
? Independently leads the MW deliverables for complex global programs
? Acts as the Lead Writer/oversight for clinical sections of eCTDs for Chinese market approval
? Oversees work of internal and/or external writers (consultants, contractors and vendors, depending on operating model)
? Attends governance meetings e.g. for protocols
? No direct people management
Profile requirements
? Minimum requirement of a bachelor’s degree in a scientific or writing discipline; Master’s degree or Ph.D. preferred.
? Minimum of 5-8 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge
? Fluent in English (oral and written).
? Ability to lead discussions on document strategy and alignment across a program
? Strong CTD knowledge and experience in generating clinical CTD documents
? Strong communication skills (verbal, written, and listening) with the ability to interpret and summarize complex data
? Excellent time and priority management; ability to work efficiently under pressure
? Minimum requirement of a bachelor’s degree in a scientific or writing discipline; Master’s degree or Ph.D. preferred.
? Minimum of 5-8 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge
? Fluent in English (oral and written).
? Ability to lead discussions on document strategy and alignment across a program
? Strong CTD knowledge and experience in generating clinical CTD documents
? Strong communication skills (verbal, written, and listening) with the ability to interpret and summarize complex data
? Excellent time and priority management; ability to work efficiently under pressure
工作地點(diǎn)
上海靜安區(qū)南京西路1601號(hào)(靜安寺地鐵站10號(hào)口步行120米)
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職位發(fā)布者
劉女士/SrRecruiter
立即溝通
愛恩康臨床醫(yī)學(xué)研究(北京)有限公司At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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