Sr Regulatory Affairs Consultant高级法规事务顾问
职位描述
JD:
High-level consulting skills
Accountability Supporting Activities
Project Execution ? Works within a team environment or individually based on the project needs
? Works within broad project guidelines and facilitates issue and conflict resolutions
? Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope
? Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
? Leverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisions
? Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
? Manages small projects and may manage larger project engagements
? Interacts with the assigned Project Specialist (PS) to ensure accurate financial management and for general project support
? Provides guidance to project team members, and acts as a mentor to junior staff
Consulting Activities and Relationship Management ? Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
? Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
? Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
? Facilitates client decision making by framing issues, presenting options and providing objective business advice
? Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
? Acts as a trusted advisor to clients and/or project team on technical and/or process issues
? Develops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
? Interacts professionally at multiple levels including senior management within a client organization
? Successfully penetrates executive management levels or other business units within a client organization
? Facilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
? Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
? Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management
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Business Development ? Maintain and continue to grow a network of industry colleagues through relationships formed during project engagements or through other industry experience
? Actively participates in project scoping calls and proposal preparation
? May deliver sales presentations and participate in bid defense meetings when needed
? Contributes information to support the account planning process and integrated marketing programs
? Contributes ideas for approaches to new clients or new service offerings
PAREXEL-related Responsibilities ? Meets established metrics as specified in scorecard on an annual basis
? Completes basic job related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management
? Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)
? May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and/or author articles.)
? Analize and interpret local guidelines and specifications for internal and external audiences
JQ:
Project management skills and experience
? Critical thinking and problem-solving skills
? Excellent interpersonal and intercultural communication skills, both written and verbal
? Client-focused approach to work
? Results orientation
? Teamwork and collaboration skills
? Proficiency in local language and extensive working knowledge of the English language
? Networking
? Business analysis
? Self-confidence and control
Knowledge and Experience:
? Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as CFDA,) is a plus
? Knowledge of the Chinese Regulatory environment essential
? ICH eCTD/CTD Experience is a plus
? Ability to interpret complex regulatory documentation and advise on adoption of guidelines
企业简介
公司简介:
国际精鼎科技股份有限公司(APEX International Clinical Research Co., Ltd. ), 成立于1996年,系协助世界各国大药厂从事新药开发及临床试验的临床研究委托机构(Contract Research Organization)。
国际精鼎临床试验研究团队是由一群具有丰富跨国性临床试验经验及专业知识的精英所组成,目前已成为亚洲地区规模最大、服务项目最完整之专业CRO公司,幷已在业界建立高品质的专业形象以及良好口碑。
APEX目前拥有超过300名的专业精英,服务遍及11个国家,在CRO的领域里已是亚洲的领导先驱。预计2007年APEX服务版图将再扩及2个国家、4个服务据点,人员也将扩增至500人。APEX重视与客户的承诺,更重视人才的培育和养成,我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境,期许同仁与公司一同成长,迈向未来。
主要服务项目:
新药开发策略的拟定与计划
国际临床试验规划及整合
引荐、甄选试验计划主持人
受试者同意书之设计
人体试验委员会之送审
最高卫生主管机关之送审
临床试验护理专员
临床研究数据处理
向亚洲地区卫生主管机关办理新药查验登记事务
中草药及健康食品临床试验、法规咨询及查验登记
愿景(Vision):创造一个在亚太地区具有国际竞争力的最精良CRO团队。
发展使命(Mission):
1 争取国际大药厂委托,执行符合国际水准的跨国性临床试验。
2 协助亚太生技及制药产业建立新药开发模式,以提升产品研发能力,幷促使产品国际化。
3 以提升临床试验品质为宗旨,拓展全球市场为目标,整合计算机及通讯科技,在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。
4 建立一个以亚洲人种高发生率疾病的基因数据库,以提供国际性新药研发机构所须之基因信息,协助其缩短药物开发时程,幷提高研发成功率。
福利制度:
.薪资:
1. 提供具竞争性之薪资(含车补及饭补)
.保险类:
1. 社会保险(依照国家规定)及住房公积金
2. 团体保险(包括寿险、意外暨医疗保险)
.制度类:
1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣,设计符合其个人之生涯规划
2. 完整的教育训练:每年公司均针对所有员工,提供完整之教育训练
3. 顺畅的升迁管道及可转调其它部门;如有职缺,亦可申请调至海外各子公司
.请 / 休假制度:
1. 服务第一年即享有9天特休, 后续年休假天数则依据服务年资及公司制度而定
2. 一年可享4天不扣薪病假
热门区域招聘: 重庆 北京 上海 浙江 江苏 广东 山东 湖南 安徽 河北
四川招聘企业: 长春金赛药业有限责任公司 四川绿康中药有限公司 成都锦华药业有限责任公司 出彩国际文化传媒(深圳)有限公司 修正药业 四川汇诚医院管理有限公司 成都第一药业 四川康宝丽健康产业投资管理有限责任公司 成都贝施美生物科技有限公司 成都健腾生物技术有限公司
职位发布日期: 2019-04-12