- 工作地点：北京
- 职位：注册专员/助理|临床试验助理|质量标准专员
- 信息来源：中国协和医科大学
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辉瑞制药三个职位招聘09应届硕士毕业生 职位一：注册专员/助理，简历收集邮箱：talent.china@ Position: Registration Officer/Associate 注册专员/助理 Working Location: Beijing JOB SUMMARY The Registration Officer /Associate (RO/RA) assists with the regulatory maintenance of a portfolio of products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. The RO/RA will assist the Registration Managers on specific projects, and in some instances will be responsible for their own projects. The RO/RA ensures that each project operates within the set timeframes, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Pfizer Standard Operating Procedures. The RO/RA may also be required to assist on special projects for the Regulatory Affairs Group. KEY RESULT AREAS & JOB ACTIVITIES /TASKS 1． Responsibilities - Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications where required - Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data - Develop an overall perspective of registration projects - Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes - Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals - Maintain and update the Local Product Document (labeling) in accordance with relevant regulations and PPG SOPs - Maintain an up to date knowledge of the relevant legislation in China - Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products - Provide regulatory advice to company personnel as required 2. Special Projects - Be required to participate on special projects for the Regulatory Affairs Group 3. Market Support - Attend Regulatory Affairs, Medical Department and other internal meetings as required - Provide a resource for other sections of the company for specified therapeutic areas 4. Personal Development - Complete the Pfizer PRE Safety Reporting Process: Overview training module in the set timeframe - Complete GDMS Training - Attend and actively participate in personal development courses as required - Attend training in specific therapeutic areas as required. - Participate in Regulatory Affairs and Medical Department projects and workshops BACKGROUND REQUIREMENTS - Tertiary qualifications in pharmacy or a science degree with a pharmacology major - Good working knowledge of international and local regulatory guidelines and codes - Proficiency in Basic Microsoft Word, PowerPoint and Excel COMPETENCIES REQUIREMENTS - Experience in more than one therapeutic area - Previous industry experience - Familiarity with the use of databases - Sustain Focus on Performance - Create an Inclusive Environment - Encourage Open Discussion and Debate - Manage Change - Develop People - Align Across Pfizer 职位二：临床试验助理，简历收集邮箱：job-c2.china@ Position: Clinical Trial Assistant Working Location: Beijing JOB SUMMARY The Clinical Trial Assistant (CTA) provides full support in clinical trial documents management to study teams during the preparation, conduction and close-out of clinical trials. This includes scanning, uploading essential documents into Electronic Library and Records Archive (ELARA), conducing Index QC, scanning Case Report Forms (CRFs), Trial Master File (TMF) Library Management, and other tasks as assigned by the Clinical Operations Manager (COM). The CTA will also support clinical supply coordinator in clincal supply management, such as drugroom management, clinical supply distribution to sites, etc. The CTA is an in-house position and reports to the Clinical Operations Manager (COM). She/he must be able to work independently, as well as in a collaborative team setting, on assigned responsibilities. KEY RESULT AREAS & JOB ACTIVITIES/TASKS 1. Clinical Trial Documents Management - Process clinical trial documents, including scanning, image QC, uploading documents to ELARA and conducting Index QC where necessary - Assist Clinical Research Associates(CRAs) in setting up investigator Site Master File (SMF) - Trial Master File Library Management 2. Clinical Supply Management during Trial Conduct Phase - Select appropriate couriers and ship clinical drugs to institutional sites. - Perform and coordinate clinical supply site-to-site transfer when necessary. - Work with CRAs on drug return and perform final drug reconciliation at the protocol level. - Work with Dalian PGM and coordinate drug destruction. 3. Drug Room Management - Perform administrative check of the air temperature and humidity of the drug room at regular intervals as instructed. - Coordinate with Human Resource department and company security to prevent fire and infestation by insects or vermin. - Inform relevant supply owners of any temperature deviations from the required condition recorded on the Storage Condition Required Form. - File and archive all supply-related forms in the drug room. - Continuously review the procedures and forms related to supply management and make amendment /update whenever required. BACKGROUND REQUIREMENTS 1. Education - College Degree or above - Medical, or Pharmacy, or other life science education background preferred 2. Working Experiences - Prefer to have had experience in assisting with clinical trial and regulatory filings documents - Preferably at least 1 year experience as a clinical trial assistant or secretary - Understanding of medical and clinical trial documents terms - Proficiency in Basic Microsoft Word, PowerPoint and Excel - Familiar with use of databases, knowledge of Access is a plus - Good English skills in speaking, reading, and writing 职位三：质量标准专员，简历收集邮箱为：recruitment.china@ Position: Quality Standards Officer Working Location: Beijing Job Summary The Quality Standards Officer (QSO) works in QS team to provide support on global SOP, policy and system implementation and ensure the compliance at WPO. The QSO is responsible for communicating WPO medical staff with global SOP, policy and system information and associated training requirement, as well as tracking local training compliance status. In case of audit by Worldwide Regulatory Affairs and Quality Assurance (WRAQA QA), the QSO acts as WPO contact in providing support on audit activities as required. In addition to above duties, the QSO may also be assigned to coordinate special projects or tasks and will contribute to the achievement of QS team and Medical Objectives. KEY RESULT AREAS & JOB ACTIVITIES /TASKS 1. Assist in Development and Implementation of Procedures, Systems and Training - Assist QS team in tracking local Implementation Guideline (IG) status in accordance with SOP revision or as business need - Maintain the current and historical version of IGs on Pfizer P drive - Process the uploading of IGs to eSOP Portal when locally approved - Assist QS team in providing QS perspective review comments on local IG development and revision, and ensure it is in compliance with global SOP, Policy and local regulatory requirement - Assist QS team in preparing of training materials of local IG as appropriate and facilitate the training courses running at WPO 2. Collaboration with QRAQA QA Audit Groups and Support of Audit/Regulatory Inspections - Attend the preparation meeting with functional teams at WPO when audit is proposed, support QS team on audit readiness activities as required - Coordinate between WPO and Corporate audit groups to support on audit logistics, report distribution, communication of local processes, updates and communication of final results - Making meeting minutes/records for audit exit meeting and support QS team on tracking audit report follow up activities with functional teams - Maintain WPO audit related documents - Support regulatory inspections as per the Global SOP on “Good Clinical Practice and Pharmacovigilance Inspections” and respective Local Site Action Plan 3. Training System Management - Process the ‘smart request’ on Power-2-Learn (P2L) system for medical new staff or staff whose position changed, based on the job role confirmation from his/her supervisor - Generate monthly tracking form on job role assignment - Assist QS team in learning activity management on P2L, namely register learning event, monitor event registration, prepare sign-in roster and submit completed roster for P2L entry. - Assist QS team in participating in local CRA workshop organized by clinical research operation team and tracking the CRA certificate status - Assist QS team in generating kinds of training analysis reports and to track training compliance of functional lines. 4. Others - Assist QS team in Induction/Orientation of New Hires of Medical Department - Assist QS team in preparing and tracking quality review activities - Daily check QS mailbox for any of queries raised from medical staff and forward to team member for response - Update and maintain the QS website with quality related document, information etc EDUCATION & EXPERIENCE REQUIREMENTS 1. Educational /Training - Educational：Bachelor's Degree 2. Working Experiences - 1 year administrative experience in medial department in pharmaceutical industry demonstrating the following: - Thorough knowledge of ICH GCP and related local regulations - Understanding of the processes associated with clinical development and regulatory operations COMPETENCIES REQUIREMENTS 1. Ability Functional - Conscientious, good team player - Must be independent, pro-active, self-motivated with strong organizational, interpersonal and communication skills - Excellent follow-up skills. - Excellent verbal and written communication skills for interaction with manager and colleagues - Proficient in both verbal and written Chinese and English - Demonstrated proficiency with all software including Outlook, Word, Excel, and PowerPoint as well as internet applications with ability to learn new applications. 2. Cultural Competencies (Leadership Behaviors) - Sustain Focus on Performance - Create an Inclusive Environment - Encourage Open Discussion and Debate - Manage Change - Develop People - Align Across Pfizer |
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