上海市 浦东新区 Responsibilities: Involvement with the composition and production of a wide range of different types of documentation concerned with health care and medical topics. Strong skills in such areas not only as writing but also analytical and research skills; as well as some knowledge in the medical field and regulatory policies / requirements for documents used in regulatory submissions. Strong writing skills and a firm understanding of medical terms. Use diagrams, anatomical images, photogr...

上海市 浦东新区 Responsibilities: Identify, evaluate and document business risks, IT General Controls (ITGC) and Application Controls (ITAC) in the risk control matrix; Perform IT internal control (SOX) review, walkthrough and conduct testing according to SOX and Group’s audit requirement to make sure the testing deliverables up to quality standard, report identified issue or area for development to management, conduct remediation testing and provide testing status to Senior Manager on time; Develop, p...

Job Responsibilities: Support medical director in drafting clinical trial protocol and study report. Contribute to the medical/scientific input given for the development of trial-related documents such as IB, ICF etc. and processes which reside in other line functions. Establish and maintain liaisons with investigators. Serve as back-up medical monitor to provide medical support to trial sites and clinical operation team. Support regulatory filing where medical expertise is required. Support dru...

The Drug Safety Physician is responsible for monitoring and management of safety profile for the assigned projects and drugs. RESPONSIBILITIES : Proactively review and evaluate the clinical implications of safety data from different sources for assigned projects. Conduct signal detection and evaluation for assigned projects. Review and input on protocols, IBs and all safety sections of clinical and/or regulatory submission documents. Draft, review Periodic Safety Report (e.g., DSUR and PSUR). Dr...

PRIMARY FUNCTION Act as principal link between the investigator and HMP for trial management, esp. on-site monitoring MAJOR RESPONSIBILITIES AND DUTIES Site management for assigned trial Be familiar with trial execution process of assigned trial Be responsible for following activities: Site selection Prepare Site specific documents include but not limit to EC presentation slide, GCP office require documents, Inform Consent, study contract, site drug management manual, subject management matrix e...

上海市 浦东新区 RESPONSIBILITIES: Major Responsibilities/Activities: Play as one of the key brand team members Involve to develop the brand plan / product strategies Develop, review and approve promotional materials Proactively share the latest medical information including clinical trial data, new publication in international conference, treatment guideline interpretation and provide summary of product efficacy and safety profile Participate key national promotional activities Medical input in portfol...

Responsibilities Conduct research to ascertain the best products and suppliers in terms of best value, delivery schedules and quality; Liaise between suppliers, manufacturers, relevant internal departments and customers; Build and maintain good relationships with new and existing suppliers; Negotiate and agree contracts, monitoring the quality of service/goods provided; Keep contract files and use them as reference for the future; Produce reports and statistics using computer software; Evaluate ...

上海市 浦东新区 Responsibilities: Interact with managed care organizations, healthcare professionals, clinical investigators, and other healthcare organizations providing fair, balanced, and scientifically rigorous medical and clinical information. Meet with healthcare professionals who might be interested in engaging in a scientific discussion regarding a product’s medical and clinical profile in the context of approved prescribing information as well as in response to unsolicited questions or request...

上海市 浦东新区 17 Responsibilities: Manage Pre-formulation group, work closely with Process group and Formulation group to meet project timelines, departmental goals. Plan, co-ordinate and oversee the work activities of Polymorph screening, Salt screening and selection, Solid state characterization (PXRD, TGA, DSC, Microscopy, etc.), Solubility determination, Particle size analysis, Recrystallization, pKa determination. Support Process group to control particle size of API with recrystallization and m...

上海市 浦东新区 Responsibilities Social & Digital Strategy / Corporate Websites Plan and develop content, and align with wider communication messaging; Update and continuously improve the websites and social media efforts ensuring that key messages and communications are consistent; Develop our social media channels (e.g. LinkedIn, Wikipedia, Twitter, WeChat, etc.); Upload press releases, announcements and scientific presentations periodically; Search Engine Optimization (e.g. Google, Baidu, Linked...

Responsibilities: Understand GCP and SOP of clinical research Assist CRM/PM/ CRA to prepare and maintain study document Review in-house documents, track and review Investigational Product and other materials Assist to resolve all outstanding DCFs as applicable Assist site payment and tracking Actively implement quality control procedures. Maintain high quality standards, through accuracy and quality of work Generate regular assigned reports and prepare presentation slides Responsible for filing ...

The primary function for this position is to manage registration related daily activities for Pharmaceutical Sciences, such as China’s and US IND, NDA, IB documents writing and tracking. Responsibilities: Participate in establishing registration strategy for CMC activities. Monitor the execution of registration strategy and project progress. Supervise CMC registration activities, including tracking the updates/amendment and reviewing submission documents. Work with every functional areas in Phar...

上海市 浦东新区 Responsibility: Back-end development and front-end design development of internal/external websites Compatibility debugging of different platforms, including compatibility with mainstream PC browsers and mobile browsers Support the corporate master data architecture design and implementation Qualification: Major in Computer Science, software engineering and so on, bachelor degree or above More than 3 years of full stack development experience Familiar with one or more languages such as ...

Responsibilities: Lead a preclinical in vitro team for drug discovery and development against oncology targets, including drug screening and developing, MOA identification in preclinical setting of small molecule/biologics drug discovery. Oversee and manage oncology projects. Supervise and mentor a team including junior PhDs and associates. Collaborate with colleagues in other department, e.g. chemistry, DMPK and clinical team. Review new targets, tracking competitor landscaps, prepare and write...

Primary Function : Quality and Compliance Management in clinical product development. Responsibilities: Implement and deliver the agreed upon Quality Control plan which includes risk management. Assist Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines. Contribute to the development of and responsible for implementation and delivery of specific initiatives as defined and agreed upon. Provide advice and support to Clinical Operations, Med...

上海市 浦东新区 Key Accountabilities Responsible for executing end to end clinical data management (CDM) activities pertaining to clinical trials, including but not limited to: Oversee the process and quality of data management work contracted to a CRO, perform data integrity review. Develop data management tool and system, perform data management activities, in compliance with Hutchison Standard Operating Procedures (SOPs) and ICH-GCP guidelines. The Clinical Data Scientist is accountable to: Provides...

Responsibility: Prepare Financial Statements by entity level and consolidation for whole Group Be responsible on the monthly review Package (Management reporting) In charge on the B/S like the reasonableness and working capital analysis Business partnering on the Functional cost like G&A/RD (Variance analysis/Trend Forecast) In charge of streamlining the finance process including operational and budgeting In involve of key ERP system Projects and financial biz model setup SOX (Design control...

PRIMARY FUNCTION Be accountable for ensuring effective, high quality and efficient management of drug safety operations’ deliverables and strategic planning for functional needs, to ensure compliance with applicable global regulations and guidelines on Pharmacovigilance. MAJOR RESPONSIBILITIES, AND DUTIES Provide strategic planning, implementation, and management of Drug Safety Operations activities. Actively monitor the development and post-marketing safety requirements per ICH, China and other...

Responsibilities: Supervise and support formulation development team to develop, optimize, scale-up, and manufacture clinical trial materials in support of early and late stage clinical studies. Work with pre-clinical and CMC teams to characterize candidate compounds through pre-formulation studies and to develop toxicological formulations and clinical formulations for IND submission and first-in-human trials. Develop dissolution and performance tests to support formulation screening and optimiz...

Responsibilities: Coordinate with relevant department to perform internal control (SOX) review, walkthrough and conduct testing according to SOX and Group’s audit requirement to make sure the testing deliverables up to quality standard, report identified issue or area for development to management, conduct remediation testing and provide testing status to Senior Manager on time; Provide support to compliance or process management\streamline projects, liaise with Management team on internal contr...