R&D Reporting Specialist

 
Location: Irvine, California
Posted On: 8/21/2017
Job Code: 6094_R&D_7316
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Job Description
 
Looking for a data orientated candidate that is comfortable with ambiguity and forging ahead to find solutions and drive process.

Responsibilities:

• Contribute to the set-up, maintenance and reporting of data in the HCP Payment and Spend System (HCP PASS). Monitor performance of reporting system and provide recommendations for process or system improvements where appropriate.

• Review contracts and payments to determine what must be reported against a healthcare provider (HCP) and/or teaching institution to comply with internal and government reporting purposes.

• Gather information to ensure that all payment and transfers of value information is captured and coded and provide guidance to influence appropriate decisions regarding all payment and in-kind reporting.

• Compile gathered information and perform data review cross checks to ensure information is accurate, complete and consistent. Identify missing, inaccurate, or incomplete data and liaise with functional areas to obtain updated data. Independently trouble shoot for missing data and documentation needed to complete required reporting. Key areas of collaboration include the following:

? Liaise with Clinical study team leads to gather details and documentation about reportable study supplies and equipment used in R&D clinical studies.

? Liaise with Compliance Operations to understand company reporting needs for R&D meetings. Work with R&D meeting owners to gather information about planned R&D meetings (e.g. investigator meetings, advisory board meetings). Review meeting request documentation for completeness (details about meeting attendees and venue) and coordinate compliance review.
Category:Non-IT  code:new
 
 
Job Requirements
 
 
Requirements:

• Basic understanding of one or more of the following: clinical study costs, Sunshine Act requirements and reporting, contracts, finance, data management, databases, and compliance

• Experience working in the pharmaceutical industry, especially in research and development

• Knowledge of clinical research and drug development concepts and FDA GCP/ICH regulatory guidelines, and understands clinical terminology

• Intermediate-advanced skills with MS Excel (skilled in using pivot tables and vlookups)

• Bachelor’s degree with 6 years relevant work experience or 4 years relevant work experience with a Master’s degree. 2 years relevant experience required with a Doctorate.
 

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Contact Details
 
Recruiter
Priyanka Sharma
 
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