R&D Project Reporting Specialist – temporary in Irvine CA
This is estimated to be a one year temporary R&D Project Reporting Specialist position in Irvine CA. We cover 65% of health insurance.
- 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.
- 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 Microsoft Excel (skilled in using pivot tables and vlookups)
The R&D Project Reporting Specialist is a data-orientated candidate that is comfortable with ambiguity and forging ahead to find solutions and drive process. Someone that is comfortable analyzing and translating data from different sources and have the technical skills to handle and manipulate large amounts of data. Candidate should have a continuous improvement mindset and should be able to demonstrate practical examples of past successes. A basic understanding of clinical study costs, contracts, finance, data management, databases, and compliance would all be advantageous along with a knowledge of the pharmaceutical industry.
- 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.
The R&D Project Reporting Specialist will report daily in Irvine, CA
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