Gena Monroy

Job Title: Diagnostics Post Performance Follow Analyst 

Pay Range: $45 

Work Schedule: M-F start 7-9 flex and end 4-6

We are seeking a Diagnostics Post Market Performance Follow Analyst  for a 1yr term temporary position supporting our client, a global life sciences and clinical diagnostics organization! The Diagnostics Post Market Performance will be responsible to perform an array of functions that may include  analyzing clinical studies, marketing evaluations, and published experiences to assess product benefit-risk and draft report conclusions. You will also participate in new product development and sustaining projects, executing studies in the laboratory as required.   Diagnostics Post Performance Follow Analyst  job duties: 

• Execute PMPF process and assures tasks are carried out by overseeing the generation and scheduling of Post Market Performance Follow up reports.
• Coordinates PMPFR inputs among cross-functional teams (R&D, Clinical Affairs, Marketing, RA/QA) in order to obtain deliverables responsible for revision of PMPF Plans and PER, as needed.
• Review and analyze scientific literature and summarize findings in applicable protocol reports.
• Guarantee all PMPF deliverables are prioritized, executed and aligned according to the Periodic Safety Update Report Publication timeline.
• Participate in new product development and sustaining projects as required, ensuring all tasks are completed accurately and on schedule.

The Diagnostics Post Performance Follow Analyst requirements:

• BS in science related field (Biochemistry, Biotechnology, Chemistry or related field)
• 1-3 years of experience
• Skill in addressing situations that need a logical, analytical, and methodical approach
• Knowledge of immunoassays, infectious diseases, bacteriology and related diagnostic techniques/instruments with a minimum of 1 year laboratory experience
• Experience in the in-vitro diagnostics industry preferred with familiarity IVDR regulation 2017/746
• Advance English level: able to communicate effectively in English and in writing
• Proficient use of applications: Word, Excel, Power Point, OneDrive, SharePoint, Teams

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