Job Description:
•Review RCR packages
•Respond to RCR reviewers/submitters on queries on essential documents
Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams
•Ensure effective management and coordination of the Regulatory Compliance Review Process
•Management of the RCR reviewer allocation process to ensure rapid package review and minimal impact on project timelines
•Tracking of RCR package status across all projects to ensure that contingency planning is in place where necessary of RCR approvals
•Analysis of package results and review of audit reports to identify trends and recurrent deficiencies – implementation of measures to address
•Preparation of RCR metrics for presentation to management
•Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
•Perform global regulatory compliance review of essential documents supporting the start of clinical studies

Candidate Profile:
Education and Experience:
Bachelor’s / Master Degree in Sciences 3-5 years of experience
English language as well as local language where applicable Attention to detail and quality of documentation
Good interpersonal skills Familiar with computers and their applications, e.g.
Word, Excel, Power Point Effective oral and written communication skills Basic organizational and planning skills
Good negotiation skills Ability to work independently with direction Proven ability to work effectively in a team environment
Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management Ability to handle multiple projects Analytical and investigative skills
Ability to interpret data

Additional Information:
Experience: 3-5 Years
Location: Asia
Education: B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job Code: 136076
End Date: 25th November., 2016

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