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Ssu & Regulatory Specialist II

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Ssu & Regulatory Specialist II

Salary/rate

$ 6000 to $ 6800 per month

Location

Beijing, CHINA

Posted

November 18 2017

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Description


This job has minimal travel of 25%

Main responsibilities:

- Assuming the responsibility for quality deliverables at the country level
- Following the requirements of the projects and the applicable country rules
- Forecasting the timeliness of submission and ensuring they are complied with
- Providing a clear rationale for delays, providing a contingency plan to mitigate impact, and escalating the issues as soon as they are identified, if the forecasted timelines are not reached
- Monitoring the basic financial aspects of the project and the available number of hours per contract escalating discrepancies on time
- Reviewing the Standard Operating Procedures (SOPs) and Work Instructions (WI) on time
- Keeping the records of training accordingly updated
- Ensuring the continuous improvement of the quality of all the components of the Site Start-up (SSU) at the country level where assigned, such as submissions, essential document collection, communication to Competent Authorities and ECs, etc.
- Following the direction of project and expertise provided by the country Start-up Advisor (CSA) designated and SSUL

- Reviewing the essential document packages required for activation of site
- Involving in essential collection of document from the site
- Preparing and submitting the Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as needed
- Preparing ongoing submissions, amendments, periodic notifications needed by the central and local EC and RA, and other local regulatory authorities needed within the country including safety notifications as needed by the local rules
- Acting as the Subject Matter Advisor for in-country performance within the Site Start-Up. Providing intelligence at the country level on start-Up (SU) and clinical trial regulatory (CTR)
- Ensuring that the local country regulatory intelligence is maintained in the central repository as it is pertaining to the activities of the local SU and CTR team, such as Competent Authority submissions, EC submissions, notifications to the data protection authorities, notifications to any other local, federal or national body, and importing or exporting the license applications where these are obtained with RA applications
- Protecting the data at the country in the absence of a legal advisor or dedicated staff
- Providing a clear data protection compliance guidance at the country level on statements of data protection that are to be included on those documents in which the Sponsor contracted to the start-up group of the Company to adapt to the local requirements
- Including the Principal Investigator Consent and the Confidential Disclosure Agreement template
- Providing inputs in local SOPs and WI
- Supporting the creation of internal training materials on the requirements of the local legislation
- Providing input to the team to assist with the resolution of the EC or CA issue at the country level
- Working with the site selection lead and PM or SSUL to ensure the selection of the appropriate sites for individual studies based on the requirements of the clinical trial
- Producing contracts that are site-specific from a country template
- Submitting proposed contracts and budgets for sites
- Working with the contracts lead to agree on a site-specific country template contract and budget
- Producing contracts that are site-specific from a country template
- Submitting proposed contracts and budgets for the site
- Negotiating budgets and contracts with the site and through the contracts lead with the sponsor until issues are resolved, and contracts are executed
- Performing other responsibilities as assigned

Requirements:

- A B.A or B.S Degree in the science or health care field, a legal degree, or any equivalent combination of education and field
- Experience of clinical research or any related field
- A sound knowledge and a good understanding of the overall drug development process
- A good knowledge of the local regulatory requirements, such as the Code of Federal Regulations and the European Union Directive
- A demonstrated knowledge of clinical development and clinical research
- Fluent written and oral communication skills in both the local and English language, and a good interpersonal skill
- A good retention of record and customer service skills
- Proficiency in computer and software systems use, such as Excel
- Ability to support the internal and external customers successfully
- Ability to develop, organize, and manage multiple tasks, with the ability to work independently

Job Type

Permanent

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