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Sr. Specialist(HGRA Compliance)

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Job Description


·     Under Functional Manager’s supervision, act as the key contact person for China Human Genetic Resource Administration Office (HGRAO) required regulatory and compliance activities to primarily contribute to business centralized support and operational process optimization for translational biomarker studies and Phase 0 trials in China

1)     Responsible for supporting study teams on timely preparation of HGRAO submission dossier, and assurance of smooth HGRAO application to be in line with regulatory requirements

2)     Proactively negotiate with HGRAO and collaborating hospitals to maximize the success of approval for each permit application.  

3)     Proactively work with study teams to address HGRAO regulations related issues and concerns to respond to internal/external environment changes, and to actively provide solutions as supported by Functional Manager and relevant stakeholders

4)     Ensure full compliance of HGRAO regulation for studies post HGRAO approval via appropriate document tracking system.

5)     Where applicable, provide training, updates and interpretation on HGRAO related policy and regulations to local study teams and cross functions

 

·     Act as the functional Training Coordinator role

1)     Develop functional annual training plan

2)     Ensure timely assignment and coordination of functional trainings for onboarding staff and ad hoc trainings for existing staff

3)     Proactively monitor and follow up on mandatory training completion and CV/JD readiness in J&J online compliance system

4)     Organize and archive functional training records for inspection readiness

 

·     Act as the functional Records Coordinator role

1)     Maintain and update J&J WWRIM required records retention information, including but not limited to Vital Records Inventory, Retention Schedules

2)     Facilitate archiving of local SOPs, Work Instructions, Guidance, etc.

3)     Manage and archive Handover Checklist for terminating and long-term leave staff

 

·     Support the functional contracting process

1)     Facilitate contracting process managed by the Scientific Operation team on essential system submissions required for contracting initiation and completion

2)     Support contract sign off procedures

Coordinate department external translation service requests especially for contracts
Qualifications

·     B.S., M.S., B.A. or M.A. degree

·     Sensitive to aspects and requirements on compliance and quality in the drug discovery and development field

·     Preferentially having relevant clinical trial experience or equivalent, but not required

·     Ability to manage multiple projects and handle priorities, and work within a matrix environment under minimal supervisions

·     Perform activities in a timely and accurate manner

·     Good organizational and strong interpersonal and negotiation skills with teamwork spirit

·     Excellent computer skills in Microsoft Office application tools (e.g., Word, Excel, Outlook, PowerPoint, etc.) and knowledge and use of database tools

·     Good attributes of attention to details

Fluent in English and Chinese
Primary Location
China-Shanghai-Shanghai-
Organization
J&J (China) Investments Ltd (7046)
Job Function
R&D
Requisition ID
1905782628W