职位描述

职位描述： Primary Responsibilities? Accurately identify and generate prose narratives for regulatory submissions according to the narrative plan by proactively monitoring the safety database and initiate narrative writing, as needed, to keep within study deadlines? Ensure narratives conform to regulatory and agreed internal standards? Ensure documents are generated in accordance with agreed internal processes and standards (eg Pfizer Global Document Style Guide), are submission ready and appropriately stored in an agreed document management system? Provide thorough QC support of documents prepared by others, as needed? Actively manage workload and track narrative progress during clinical team reviews and QC? Prepare documents for internal audit and address any audit findings accurately and in a timely fashion? Develop and maintain knowledge of all applicable global regulations and guidelines, standard operating procedures and practices? Understand the functions and roles within the study team and the Safety lines (Worldwide Safety Strategy and Worldwide Regulatory and Safety Operations) and communicate and align with them in the delivery of narratives to meet project-related goals? Ensure own work processes are constantly improved to reflect lessons learnt from previous experiences? Assist with special projects, as requested? May participate in CRDC initiatives to increase efficiency and productivityTechnical Skill Requirements? Excellent grasp English, both written and verbal, able to communicate effectively.? Extensive clinical knowledge? Demonstrable ability to communicate clinical data succinctly, clearly and accurately in writing, in English? Knowledge of International Conference on Harmonisation (ICH) guidelines and regulatory requirements and demonstrable ability to interpret and apply these guidelines in a report writing setting? Knowledge of the safety database and other narrative generation tools? Basic experience of working in electronic document management systems? Basic knowledge of using Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook)Qualifications? At least bachelor degree or equivalent in medical-related or life sciences.? Knowledge/experience of preparing safety narratives or medical regulatory documents as a medical writer within or for the pharmaceutical / healthcare / regulatory industry? Clinical experience required? Ability to manage multiple priorities within timeframe? Ability to work effectively under pressure? Must be accurate and have an excellent attention to detail? A balanced approach to problems, using flexibility and persistence as appropriate? Ability to deliver within agreed timelines and monitor / communicate progress against agreed milestones? Demonstrable excellent interpersonal and team-working skills exhibiting active listening skills and professional behavior, assertive? Ability to work in a matrix organization with people in cross-functional lines and scientific staff from a range of disciplines? Ability to work effectively in a multicultural context and with colleagues in different country operationsPreferred Additional Experience? Post-graduate degree (Masters or above) or overseas university education? Ability to present with similar ease to both scientific and non-scientific audiences? Expertise in interacting with cross functional study teams? Experience in writing Phase 1 to 4 clinical study reports as a medical writer in the pharmaceutical/healthcare industry for at least 2 years.? Demonstrable communication skills in a variety of media settings (e.g. teleconference) 职能类别： 其他 英语翻译

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