• 无工作经验
  • 招若干人
  • 11-09 发布

职位描述

职位描述: One of the world’s largest CROs, PRA HealthSciences is transforming clinical trials through our people, innovation and operational transparency. Our 10,000+ employees operate in more than 80 countries, delivering a broad spectrum of clinical trial solutions that meet the demands of a diverse marketplace. It is our philosophy that the way in which we grow our business is to focus on our employees. As such, we recognize that successful careers are found within organizations that provide the support that employees need at work, the benefits they require outside the office as well as a good work / life balance.Strategies and Medical affair activities and Leadership1.Proactive contribute to Local IPS plan and/or LRR cross functionally (MA, SMA).2.Develops, drive and Lead medical plans under the scope of IPS on behalf of whole medical affairs function (MA/SMA).3.Medical governance for both promotional (as such but not limited to the followings Strategic Imperatives, Key messages, Detailing Aids, launch pad materials) and non-promotional materials as a faculty member of materials clearance committee (MCC) to ensure full alignment with NP4 guideline and compliance requirement. (AMA/MA/SMA)4.Lead and develop (medical) product pre-launch and launch strategy and execution.5.Ensure compliance with safety reporting requirements and RMP execution by working with DS&E. (AMA/MA/SMA)6.Review patients compensation claims by suspected AE for assigned products. (AMA/MA/SMA)7.Actively participate cross functional actions, provide an appropriate updates (KA, MA, Development ...)8.May serve as representatives in GMAT (Global Medical Affairs Team) and CPT (China Project team sponsored by development) on behalf of China Medical team. (MA/SMA)Medical Material management1.Generate Key scientific messages for assigned product(s)2.Transfer scientific studying results to key brand message through proper analysis and interpretation. (AMA/MA/SMA)3.Provide comprehensive Medical presentations and training to internal and external customers, for the accurate delivery of messages. (AMA/MA/SMA)4.Build strong relationship with scientific associations through advisory board meetings, Steering committees. (AMA/MA/SMA)5.Contribute scientific/medical content development (small meeting kits, DAP material, etc.), may be required to serve as a speaker in scientific event, i.e. deliver a high quality educational session on behalf of NovartisEvidence generation and Medical Affairs Studies Management (MAS)1.Design, initiate, coordinate and manage local PMS /Observational studies, Phase IIIb / IV studies in line with GCP, Local regulations and Global IPS Strategy and plan. (AMA/MA/SMA)2.Define IIT Strategies and responsible for the whole process of execution of IIT in align with GCP, Local regulations, including contract, payment and publication. (MA/SMA)3.Ensures GCP compliance and adherence to Novartis Standard Operating Procedures (SOPs) for conduct of trial activities. (AMA/MA/SMA)4.Be responsible for approval process (Local/Global approval) . (AMA/MA/SMA)5.Lead and oversee the Budget of medical affairs studies, database management, CSR and publication process and results. (MA/SMA)6.Be responsible for Documents Preparation (Study Concept Sheet, Protocol and final study reports and publications) of Medical affairs studies. (AMA/MA/SMA)7.Be responsible for design and implementation of other researches such as RWE, Chart review, Registries and meta-analysis (MA/SMA)8.By request, oversight and management of third party studies, animal/in vitro studies. (AMA/MA/SMA)9.Oversight study Management (Database, review and CSR completion) and coordinate with MACO or designated clinical operation team to manage clinical contract in IIT. (MA/SMA)10.Responsible for clinical study feasibility review.Qualifications:–Preferred Master Degree in clinical medicine with 2+ years’ experience in clinical practice and/or clinical research (can work in Beijing and Shanghai).–Work experience within the pharmaceutical industry and proven knowledge on Global and Local regulations, Code of industry and drug development process.–Fluent in Chinese and English writing and speaking–Well-developed planning and time management skills;–Strong communication and interpersonal skills;–Customer orientation;–Advanced Knowledge of allocated therapeutic area including patient’s treatment status and unmet needs, society and KOLs.–Strong scientific writing skills and data interpretation skills in scientific publications in national and international journals 职能类别: 医药学术推广

联系方式

北京市朝阳区建国路91号金地中心B座917

公司信息

RPS Inc. is a next generation global CRO, headquartered in the United States with the operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions. RPS provides comprehensive global Phase 1-4 clinical development solutions to the pharmaceutical, biotechnology and medical device industries. By combining an experienced clinical research operations infrastructure with the industry’s largest resourcing engines, RPS is uniquely positioned to offer our Clients both integrated and full service global outsourcing solutions. These solutions are powered by highly experienced and seasoned study teams providing innovative, cost-effective and high quality services. RPS Asia Pacific Headquarters is located in Beijing, China and we have operations in 11 Countries in Asia Pacific region. With the rapid organic expansion of RPS in China & Asia Pacific, we are continuously looking for the experienced industry talents to join us. Our specialized staff of consultants is eager to discuss your career plans. Tell us about yourself experience, so the appropriate consultant can contact you. RPS is sensitive to your daily responsibilities. Tell us EXACTLY how to contact you and we will. For your convenience, you can also submit your resume. We look forward to discussing the opportunities and benefits of employment with RPS! For more information, please visit our website www.rpsweb.com.

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