
Sr Regulatory Affairs Consultant高級法規(guī)事務(wù)顧問

職位描述
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
?
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
企業(yè)簡介
公司簡介:
國際精鼎科技股份有限公司(APEX International Clinical Research Co., Ltd. ), 成立于1996年,系協(xié)助世界各國大藥廠從事新藥開發(fā)及臨床試驗(yàn)的臨床研究委托機(jī)構(gòu)(Contract Research Organization)。
國際精鼎臨床試驗(yàn)研究團(tuán)隊(duì)是由一群具有豐富跨國性臨床試驗(yàn)經(jīng)驗(yàn)及專業(yè)知識的精英所組成,目前已成為亞洲地區(qū)規(guī)模最大、服務(wù)項(xiàng)目最完整之專業(yè)CRO公司,幷已在業(yè)界建立高品質(zhì)的專業(yè)形象以及良好口碑。
APEX目前擁有超過300名的專業(yè)精英,服務(wù)遍及11個國家,在CRO的領(lǐng)域里已是亞洲的領(lǐng)導(dǎo)先驅(qū)。預(yù)計(jì)2007年APEX服務(wù)版圖將再擴(kuò)及2個國家、4個服務(wù)據(jù)點(diǎn),人員也將擴(kuò)增至500人。APEX重視與客戶的承諾,更重視人才的培育和養(yǎng)成,我們提供完整的教育訓(xùn)練、職涯規(guī)劃、優(yōu)于市場的薪資福利、良好工作環(huán)境,期許同仁與公司一同成長,邁向未來。
主要服務(wù)項(xiàng)目:
? 新藥開發(fā)策略的擬定與計(jì)劃
? 國際臨床試驗(yàn)規(guī)劃及整合
? 引薦、甄選試驗(yàn)計(jì)劃主持人
? 受試者同意書之設(shè)計(jì)
? 人體試驗(yàn)委員會之送審
? 最高衛(wèi)生主管機(jī)關(guān)之送審
? 臨床試驗(yàn)護(hù)理專員
? 臨床研究數(shù)據(jù)處理
? 向亞洲地區(qū)衛(wèi)生主管機(jī)關(guān)辦理新藥查驗(yàn)登記事務(wù)
? 中草藥及健康食品臨床試驗(yàn)、法規(guī)咨詢及查驗(yàn)登記
愿景(Vision):創(chuàng)造一個在亞太地區(qū)具有國際競爭力的最精良CRO團(tuán)隊(duì)。
發(fā)展使命(Mission):
1 爭取國際大藥廠委托,執(zhí)行符合國際水準(zhǔn)的跨國性臨床試驗(yàn)。
2 協(xié)助亞太生技及制藥產(chǎn)業(yè)建立新藥開發(fā)模式,以提升產(chǎn)品研發(fā)能力,幷促使產(chǎn)品國際化。
3 以提升臨床試驗(yàn)品質(zhì)為宗旨,拓展全球市場為目標(biāo),整合計(jì)算機(jī)及通訊科技,在國際上提供客戶兼具成本效益及效率的臨床試驗(yàn)數(shù)據(jù)處理中心。
4 建立一個以亞洲人種高發(fā)生率疾病的基因數(shù)據(jù)庫,以提供國際性新藥研發(fā)機(jī)構(gòu)所須之基因信息,協(xié)助其縮短藥物開發(fā)時程,幷提高研發(fā)成功率。
福利制度:
.薪資:
1. 提供具競爭性之薪資(含車補(bǔ)及飯補(bǔ))
.保險類:
1. 社會保險(依照國家規(guī)定)及住房公積金
2. 團(tuán)體保險(包括壽險、意外暨醫(yī)療保險)
.制度類:
1. 學(xué)習(xí)發(fā)展計(jì)劃 (Learning & Development): 針對個別員工之專業(yè)及興趣,設(shè)計(jì)符合其個人之生涯規(guī)劃
2. 完整的教育訓(xùn)練:每年公司均針對所有員工,提供完整之教育訓(xùn)練
3. 順暢的升遷管道及可轉(zhuǎn)調(diào)其它部門;如有職缺,亦可申請調(diào)至海外各子公司
.請 / 休假制度:
1. 服務(wù)第一年即享有9天特休, 后續(xù)年休假天數(shù)則依據(jù)服務(wù)年資及公司制度而定
2. 一年可享4天不扣薪病假
職位發(fā)布企業(yè)

精鼎醫(yī)藥研究開發(fā)(上海)有限公司
企業(yè)性質(zhì):民營企業(yè)
企業(yè)規(guī)模:50-99人
成立年份:1996
企業(yè)網(wǎng)址:www.apex-cro.com
企業(yè)地址:浦東新區(qū)
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職位發(fā)布日期: 2019-04-12