莆田招聘

Reports To(ADM02):Lead TMF Document Specialist
Assignment Duration(ADM02): Contracted resource
Zone / Line:Development Operations, WRDC

Position Purpose(ADM02):
The TMF Document Specialist is responsible for supporting TMF completeness through the review, coding, tracking/validation of paper and electronic documents. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any mis-indexed or incomplete documents with the Document Owner. Upon direction, the TMF Document Specialist will create and activate the TMF repository and process corresponding templates and program level documents into the repository.

Organizational Relationships(ADM02):
· Reports directly to the Lead TMF Document Specialist
·Liaise with TMF Study Owners, Document Owners, and Document Submitters, as needed

Major Duties (ADM02):
General
• Upon direction, create and activate the initial TMF repository according to finalized study TMF specifications.
• Associate existing templates and program level documents to the TMF repository.
• Upon receipt of paper documents, review documents to for completeness (i.e. missing pages) and ensures criticality assignments and indexing terms are accurate on all documents received.
• Prepare and process/upload documents including application of full indexing terms within the TMF system within specified departmental timelines, based on document criticality. Review uploaded documents for readability and verify indexing terms were transferred correctly from the document into the TMF system.
• Prepare processed paper documents for archival
• Upon notification, archive documents as needed, per the archival process
• Retrieve electronic documents for processing per study assignment/criticality.
• Perform document completeness QC on all received documents per TMF Readiness Criteria including readability.
• Review documents for indexing accuracy; check submitted indexing terms and index document with full attributes as needed.
• Follow-up with Document Owner for discrepancies and log errors.
• Review TMF repository to verify an exact duplicate of the document has not previously been activated.
• Activate document into the repository and inform Document Owner, as applicable

Training & Education Preferred(ADM02):
In general, candidates for this job would have the following levels of experience:
Minimum of Bachelor’s degree or equivalent required.
Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical records preferred

Experience with the following applications types is preferred:
• Electronic documentation management systems
• Web based data management systems, as required
• Database utilization
Excellent English verbal and written communications skills, combined with outstanding listening skills are required.
History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
History of achievement in building strong customer relationships.

Prior Experience Preferred(ADM02):
• Hands-on experience with electronic documentation management systems.
• Experience in management of medical/clinical study records and documentation
• Experience/knowledge of ICH/GCP documentation requirements

Technical Competencies(ADM02):
Competency
• Computer savvy with widely used systems e.g. MicroSoft Office
• Understanding of a Trial Master File and it’s components
• Organizational skills
• Communication skills
• Administrative excellence
• Clinical/Scientific aptitude
• Technology management
• Decision Making
• Problem solving

Detail / Comments (specific skills, etc.)
• Working knowledge of electronic document management systems.
• Knowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industry
• Ability to work independently. Ability to organize tasks, time and priorities of self ; ability to multi-task.
• Ability to communicate effectively and appropriately with internal & external colleagues, locally and globally
• Attention to detail evident in a disciplined approach to document maintenance and management
• Understanding of scientific/clinical principles, and ability to work across different therapeutic areas
• Understanding of technologies to support document collection and archiving, awareness of CFR 21 part 11
• Ability to make routine decisions based on following set guidelines and procedures
• Ability to recognize incorrect document information and work within the team to resolve problems.


Behavioral Competencies(ADM02):
Competency
• Quality Awareness
• Collaborative, supportive
• Innovation
• Networking and Alliance Building
• Learning Organization
• Flexibility
• Teamwork
• Initiating and Implementing change
• Customer Focus

Detail / Comments (specific skills, etc.)
• Ability to develop and carry out plans to improve one’s work.
• Work successfully with others to ensure team effectiveness and demonstrate Pfizer values
• Recommend continuous process improvements
• Look for opportunities for collaboration to help deliver study goals and acts upon them
• Contribute to a learning environment by sharing knowledge and best practice within and across study teams. Assists with mentoring other team members in core discipline.
• Ability to take on new projects and adapt to new processes and procedures
• Respond positively and constructively to changing situations
• Assist other team members to ensure timelines are met
• Ability to work independently and within a team; show respect and support for all team members.
• Work collaboratively with group members and contribute to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line
• Advocate and encourage actions that improve existing approaches and systems.
• Proactively manage change by identifying opportunities and coaching self and others through the change
• Identify and build effective relationships with customers and other stakeholders.

简历收集邮箱：job-c2.china@pfizer.com

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.