长沙招聘

知名医药研发公司 招聘【项目协调专员】

合同签订中智外包，续约及编制机会Open

要求：统招本科学历，2年左右外企助理经验，数据能力熟练，英文书面良好，如是医药、生物或相关行业或熟悉相关项目文档优先

Summary:

The Project Documentation Specialist (PDS) is responsible for the completeness and compliance of documentations submitted to relevant regulatory authorities in support of protocol initiation, amendment, or regulatory inspections as assigned by the Covance CLS (CCLS) Global Project Management department (GPM). The PDS is responsible to coordinate on behalf of Global Project Management with other CCLS departments involved to ensure the completeness of the documentations. The PDS is, however, only responsible for the accuracy of information and data provided by GPM, and not for those by other departments. The PDS is required to maintain awareness of current applicable regulatory documentation requirements and proactively update GPM on the latest standards. This position must be in compliance with the CCLS GPM strategy and deliver outstanding customer satisfaction and performance.

Responsibilities / Duties

Review of regulatory application form against the SOW to ensure accuracy and compliance

Coordinate with other departments for the completeness of documentations / applications

Obtain relevant internal authorization for the documents as applicable

Close collaboration with the Global Study Manager (GSM) or the Regional Study Coordinator (RSC) for all regulatory documentations aspects of the protocol.

Maintain knowledge of current regulatory documentation requirements and guidelines, and communicate with the Global Project Management team of any changes

Maintain all records related to the regulatory documentations / applications for the ease of retrieval in case of inspection

Responsible for implementing compliance monitoring of regulatory documentation practices and taking corrective and preventive actions when needed

Ensure a detailed knowledge of the SOW specifications and a good understanding of how the SOW specifications impact every operational aspect of the clinical trial, in particular those relevant to the regulatory documentations / applications

Monitor, and track the completion of all regulatory documentations / applications support requests assigned. Keep the GSM or RSC informed of the progress and follow-up with the GSM or RSC if it is pending action by the client.

Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date

Ensure compliance with departmental guidelines and company standards.

Comply with CCLS Global Project Management strategy

Support a culture of continuous improvement, quality and productivity

Other duties as assigned

Education / Qualifications

Ability to use computer and office software applications (e.g. Microsoft Word, Excel, and Outlook)

Interpersonal skills

Strong in English, and Chinese (Mandarin)

Strong administrative and organizational skills

Preferred:2 year vocational or Associate’s Degree in Life Sciences or equivalent

Experience

Preferred 2 years’ experience in applicable field

Demonstrated ability to plan and prioritize.

Demonstrated communication and organizational skills.

Demonstrated attention to detail.

Demonstrated documentation skill.

Proven ability to excel in a fast paced environment

Proven teamwork

Demonstrated ability to liaise with internal departments

Location: 浦东新区张江高科技园区李冰路

上海中智项目外包咨询服务有限公司是中智上海全资子公司，发展至今，经与几千家各个行业的企业成功合作，服务网络覆盖全国300多个城市。以服务外包的形式为企业提供“优质、高效、便捷”的灵活用工、项目管理、办公室商务服务等，其中全球500强企业占比超过50%，涉及制造、金融、化工、医药、奢侈品与消费品、进出口贸易等行业，并且与服务客户建立了良好的合作伙伴关系。
中智将以不懈追求卓越的精神，坚持传承与创新，积极探索企业发展的新方向、新路径，推动企业实现新发展，继续强化质量意识，加强质量管理，落实质量责任，提高服务质量，进而为将上海建设成“具有国际竞争力的质量高地”作出更大的贡献。