
Sr Regulatory Affairs Consultant高級法規事務顧問

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,系協助世界各國大藥廠從事新藥開發及臨床試驗的臨床研究委托機構(Contract Research Organization)。
國際精鼎臨床試驗研究團隊是由一群具有豐富跨國性臨床試驗經驗及專業知識的精英所組成,目前已成為亞洲地區規模最大、服務項目最完整之專業CRO公司,幷已在業界建立高品質的專業形象以及良好口碑。
APEX目前擁有超過300名的專業精英,服務遍及11個國家,在CRO的領域里已是亞洲的領導先驅。預計2007年APEX服務版圖將再擴及2個國家、4個服務據點,人員也將擴增至500人。APEX重視與客戶的承諾,更重視人才的培育和養成,我們提供完整的教育訓練、職涯規劃、優于市場的薪資福利、良好工作環境,期許同仁與公司一同成長,邁向未來。
主要服務項目:
? 新藥開發策略的擬定與計劃
? 國際臨床試驗規劃及整合
? 引薦、甄選試驗計劃主持人
? 受試者同意書之設計
? 人體試驗委員會之送審
? 最高衛生主管機關之送審
? 臨床試驗護理專員
? 臨床研究數據處理
? 向亞洲地區衛生主管機關辦理新藥查驗登記事務
? 中草藥及健康食品臨床試驗、法規咨詢及查驗登記
愿景(Vision):創造一個在亞太地區具有國際競爭力的最精良CRO團隊。
發展使命(Mission):
1 爭取國際大藥廠委托,執行符合國際水準的跨國性臨床試驗。
2 協助亞太生技及制藥產業建立新藥開發模式,以提升產品研發能力,幷促使產品國際化。
3 以提升臨床試驗品質為宗旨,拓展全球市場為目標,整合計算機及通訊科技,在國際上提供客戶兼具成本效益及效率的臨床試驗數據處理中心。
4 建立一個以亞洲人種高發生率疾病的基因數據庫,以提供國際性新藥研發機構所須之基因信息,協助其縮短藥物開發時程,幷提高研發成功率。
福利制度:
.薪資:
1. 提供具競爭性之薪資(含車補及飯補)
.保險類:
1. 社會保險(依照國家規定)及住房公積金
2. 團體保險(包括壽險、意外暨醫療保險)
.制度類:
1. 學習發展計劃 (Learning & Development): 針對個別員工之專業及興趣,設計符合其個人之生涯規劃
2. 完整的教育訓練:每年公司均針對所有員工,提供完整之教育訓練
3. 順暢的升遷管道及可轉調其它部門;如有職缺,亦可申請調至海外各子公司
.請 / 休假制度:
1. 服務第一年即享有9天特休, 后續年休假天數則依據服務年資及公司制度而定
2. 一年可享4天不扣薪病假
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熱門區域招聘: 重慶 北京 上海 浙江 江蘇 廣東 山東 湖南 安徽 河北
四川招聘企業: 長春金賽藥業有限責任公司 四川綠康中藥有限公司 成都錦華藥業有限責任公司 出彩國際文化傳媒(深圳)有限公司 修正藥業 四川匯誠醫院管理有限公司 成都第一藥業 四川康寶麗健康產業投資管理有限責任公司 成都貝施美生物科技有限公司 成都健騰生物技術有限公司
職位發布日期: 2019-04-12