以下信息是拜耳,辉瑞,西安杨森等几家公司的职位招聘信息,有意向着可尽快投简历。
(1)Position: Global Submissions Assistant (12 persons) Report to: Deputy Director, Head of Global Regulatory Affairs Compliance and Operation Asia Location: Beijing Responsibilities • Performs quality control of PDF documents with respect to technical compliance and updates documents to meet eCTD standards including technical format according to current ICH, FDA and EMEA as well as internal company guidance. This includes quality control and creation of bookmarks and hyperlinks as well as margins and legibility along with other advanced Adobe Acrobat editing functions. • Performs quality control on Word documents and updates Word documents to ensure that technical formatting requirements are met. Uses advanced Word features in lengthy and structurally complex documents. • Prepares Case Report Forms according to FDA guidance, introducing advanced navigation features. • Performs a technical review on regulatory relevant documents including the usage of various software tools and advises all disciplines of any corrections to be made regarding the format of these submission documents • Performs the compilation of Clinical Study Reports (CSR) including an internal technical review of the published result according to the current regulatory requirements • Uses technical computer know-how/experience to work independently and apply problem-solving skills to address issues with software functionality and/or publishing output. Tests hypothesis, proposes solutions and shares learning experiences with other Global Submissions staff. Accountable for thorough quality assurance validation and release of dossiers prior to submission. • The incumbent assists in the implementation and maintenance of electronic submission/document management standards, processes, and procedures which apply internationally and across disciplines. • Assists in the evaluation and validation of new software functionality or IT-systems used in the electronic submission process in order to keep up with evolving Health Authority guidelines/regulations as well as for process improvement and productivity/efficiency initiatives. Qualifications Education: • The incumbent is required to have a Bachelor’s Degree or equivalent, preferably in computer science or English Personal characteristics • Very careful and patient • Good at logical thinking and problem solving • Courteous interaction with professional staff at all levels within BSP worldwide • Intermediate written and oral English communication skills are necessary
(2) Position : Regulatory Database Operator 2 persons (contractor) Report to: Deputy Director, Head of Global Regulatory Affairs Compliance and Operation Asia Location: Beijing
Responsibilities Administration and organization of documents in the Documentum™-based electronic document management system (GlobeDoc) according to the needs of the regulatory affairs department • Adaptation of folder structures • Re-sorting of documents • Ensure that the attributes of documents in the current system are filled with correct values to ensure that documents can be migrated smoothly to a new system in the scope of the BSP R&D eDMS Project • Regular quality control checks together with the respective document / process owners within the regulatory affairs department Qualifications • Degree from a technical college or university of applied sciences or equivalent. • Very good knowledge of MS Word and experience with other software such as databases • Good knowledge of document management • Good command of English, especially reading and writing Personal characteristics • Very responsible and careful • Good at organizing own work • Good ability to deal with deadlines under pressure • Good communication skills • Ability to work in global virtual teams • Creative thinking and analytical skills
3 Pfizer JOB DESCRIPTION JOB TITLE: Regional Product Physician (RPP)/Regional Medical Research Specialist (RMRS), Oncology Pfizer Pharmaceutica REPORT TO: Shi Yang –Product physician, Oncology New Product Chen Jie–Senior Product physician/Teamleader, Oncology Medical NAME: Location Beijing , Shanghai ,Guangzhou JOB SUMMARY Regional product physician/Regional Medical Research Specialist (RPP/RMRS) –is the medical professional representing Pfizer in communicating with regional KOLs and academia for the defined therapeutic areas to serve the medical information need of regional key customers and the enhance the partnership with regional academia. RPP/RMRS – is required to enhance medical communication between Pfizer and therapeutic experts and researchers in the region, timely communicate medical updates and product information, support medical program development, facilitate research proposal screening and study placement. RPP/RMRS– serves as local medical resource for field force training to in defined therapeutic areas to improve the internal medical capability. As such, good understanding and comprehensive knowledge of the defined therapeutic area, proactive attitude and professional behavior are mandatory. KEY RESULT AREAS & JOB ACTIVITIES /TASKS i) Field based medical to medical communication a) Communicate complex cutting edge technical information, and product update to health care decision makers as aligned with Pfizer Chinas corporate goals and objectives. b) Collaborate with Pfizer colleagues to actively support medical and scientific meetings by collecting and interpreting insights / presentations / results. c) To speak at medical communication meeting. d) Meet customer needs and expectations with regards to assigned Brand(s) for delivery of Product messages to key influencers (KOLs)
ii) Field based KOL Management a) Contributes to mapping/ profiling of KOLs in line with segmentation (national, regional). b) Work with product physician, product manager and sales manager proactively to ensure market preparation pre- and post-launch. c) May function as the medical product champion. Work as strategic partner with Local Marketing for Pfizer China development project(s) and marketed product(s). d) Support local medical association to standardize medical practice, facilitate doctor and patient’s education e) Support publication plan- Follow up the implementation and timely publication of post marketing clinical activities including local profiling programs when applicable.
iii) Investigator Initiated Research Discussion and implementation a) Discuss research concept with interested researcher, and communicated the nature and requirement of Pfizer’s IIR b) Facilitate submission of investigator initiated pre-clinical and clinical proposals, and act as a Liason between Pfizer and IIR researcher c) Facilitate research proposal screening and study placement, and follow up activities d) Support Pfizer sponsored Non interventional study if applicable
iv) Medical Input in product commercial Activity a) Collect, analyze and report local customer medical insights to assist business decision making b) Report local competitive intelligence in clinical research and medical positioning to share internally and externally as post-meeting deliverables.
v) Medical Training a) Provide internal therapeutic area or product training to Pfizer colleagues (i.e. sale force ongoing and new hire training programs). b) Present at regional sales cycle meeting c) Resolve medical questions related assigned products at field BACKGROUND REQUIREMENTS 1. Education Oncology Medical Background, Master Degree or above in the defined therapeutic area is preferred 2. Working Experiences i. At least 3 years clinical practice or medical affairs experience in other multinational pharmaceutical companies ii. Good medical knowledge for the defined therapeutic area iii. Good understanding about pharmaceutical business iv. Proficiency in English and good computer usage
COMPETENCIES REQUIREMENTS 1. Technical Competencies Strong and continuous learning capability and adaptability good interpersonal communication skills Customer focus Proactive planning and result oriented Excellent Teamwork/Collaboration
2. Cultural Competencies (Leader Behaviors) Sustain Focus on Performance Align Across Pfizer Create an Inclusive Environment Manage Change Model openness and innovation through words, actions, and decisions. Demonstrate tact and organizational savvy when communicating and interacting with others. Share learning, including entrepreneurial and innovative ideas, with others. Hold self accountable for performance and encourages others to achieve and be accountable for performance.
Career International Inc. Tel:+8610 59271344 Add: Rm. 13, China Life Tower, No. 16 Chaoyangmenwai Street , 100020 Web:www.careerintlinc.com Email: kellyguo@chinacareer.com
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