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 500强猎头职位-知名CRO诚聘：Medical Writing（医学报告撰写） |
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Morie
头衔: 海归上士
性别: 
加入时间: 2012/05/29
文章: 10
海归分: 1881
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作者：Morie 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
企业介绍：公司是全球医药服务行业的领导者，通过提供创新、优质的专业技术、市场信息和合作方案，适应临床医药、生物科技，医疗卫生事业的需要，提高世界医疗水平。公司为多个医疗领域提供临床研究、中心实验室、数据统计等多项专业服务，服务范围涵盖中枢神经系统、肿瘤治疗、心血管疾病、血栓病、呼吸道疾病、泌尿系统疾病、自体免疫疾病，内分泌疾病和各类感染性疾病等。同时帮助完成了全球最畅销30种药品及最畅销9种生物制剂的研发或者商业化工作，为提高全人类的健康水平做出了贡献。
PURPOSE
Manages and supports a team of Medical Writing (MW) staff to efficiently produce documents that meet customer requirements. Participates in project teams and may provide service as an independent expert. May serve as writing lead and project manager for MW projects.
RESPONSIBILITIES
• Line manager of staff, typically below Senior Medical Writer level and probably ba<x>sed at one site. Responsible for performance of direct reports (quality, profitability, utilisation). May be responsible for performance of a small MW site.
• Works with senior management to understand and interpret SBU strategy and effectively communicates strategy to direct reports. Ensures ob<x>jectives of individual staff are in line with the overall MW ob<x>jectives.
• Acts as Lead Medical Writer on any type of writing project, with limited guidance from senior staff, and consistent high quality and efficiency. Can use experience and initiative to tackle new/unusual document types and customer requirements.
• Reviews and monitors budget for own projects and those of direct reports, including out of scope activities, and ensures that revenue is recognised as appropriate. Can provide independent review of budgets and costings for routine projects. Proposes costings for less routine projects, out of scope activities, and potential budget efficiencies, with guidance from manager. May present on project-specific MW proposals at a full-service bid defense meeting (e.g. managing a series of projects to ensure consistency), with management input to slides as required.
• May provide senior review and guidance for most documents prepared by junior staff. May design training materials and input into generic training plans. May plan and deliver general training on MW to other Quintiles groups and externally, as appropriate.
• May act as Project Manager for a small series of stand-alone MW projects (e.g. series of related CSRs). May coordinate MW activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
• May represent region or site on a MW initiative or cross-functional initiative.
• Keeps abreast of current data, trends, MW/regulatory knowledge, developments and advances in area of drug development/MW.
• May propose revisions to SOPs or suggest process improvements for consideration. May draft new MW SOPs for review and act as reviewer for MW SOPs, as assigned and appropriate.
• Sets SMART goals and ob<x>jectives for staff.
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Excellent standard of written English. Ability to communicate fluently and effectively with colleagues and customers in English, both in writing and verbally
Ability to see the "bigger picture" and promote this to staff Developing abilities to deal with personnel issues, staff expectations, conflict management
Ability to provide fair, timely, appropriate and constructive feedback and guidance to staff
Confidence and appropriate communication in representing staff issues or concerns to senior management
Confidential and sensitive approach to earn trust of staff
Acts as a positive role model to staff in attitude to, and dealings with, colleagues and customers
In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance
Good understanding of common statistical methods used in clinical trials and interpretation of their results
Understanding of the time needed to perform routine MW tasks, agree appropriate timelines, and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions
Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority
Ability to identify deficiencies, errors, and inconsistencies in documents
Ability to effectively review a statistical analysis plan
Ability to identify deficiencies, errors, and inconsistencies in statistical output
Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and direct reports
Confidence in raising and discussing more sensitive topics without management intervention
Confident and effective chairing of small to medium-sized meetings
Ability to understand the customer's point of view and proactively address customer concerns
Ability to work on several projects at once while balancing multiple and overlapping timelines
Ability to assess and prioritize workload
Demonstrated abilities in collaboration with others and independent thought
Knowledge of regulations relevant to MW
Careful attention to detail and accuracy
Must be computer literate
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in a life science-related discipline, with at least 5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including extensive experience in preparing clinical study protocols and reports, with consistently positive customer feedback; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Occasional travel
Approvals
Job Family Management
Mark Dudley – Senior Director and Head, Global Medical Writing
Human Resources
Janet Jones – Exec Director, Compensation
Approvals are
工作地点：北京
作者：Morie 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
标签: 药品安全,
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 500强猎头职位-知名CRO诚聘：Medical Writing（医学报告撰写） -- Morie - (6637 Byte) 2012-6-05 周二, 13:40 (1873 reads)
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