Medical Scientist Ophthalmogy Needed (Long Term Contract)

[BioPoint]

.BioPoint is currently seeking a Safety Scientist Consultant with medical device experience for a 12 month (40+ hour) contract assignment. Primarily responsible for supporting study planning, conduct, and reporting activities. These include the development of safety-related sections in protocols, IB's, informed consent documents, risk management plans, CRF's, and CSR's. Assist with processing and reporting of incoming safety events and related data supporting studies in corneal refractive surgery..

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.We also offer a $1000 referral bonus should you refer someone else.
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.Client has sites in Florida, Texas, and NY,.
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ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:.
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• .Represent Medical Safety on various project teams.
• .Support Medical Device clinical trials phases and regulatory submissions reporting.
• .Assist with study planning and data evaluation of investigational surgical devices .
• .Review clinical safety data and create individual/aggregate case narratives..
• .Responsible for authoring IDE/PMA sections..
• .Risk management input/planning for pre-market products.
• .Must be very strong multitakser and able to deliver high quality work independently.
• .Reviewing incoming safety information for completeness and accuracy.
• .Generating queries.
• .QC of cases.

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.SKILL SET REQUIRED:.
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• .Ophthalmology / Optometry degree with 2-5 years progressive scientific research experience. Ophthalmology safety surveillance is highly desired. .
• .Able to develop knowledge of protocol, regulatory requirements and company SOPs..
• .Familiar with matrix team structure and phases of medical device research..
• .Strong Regulatory Experience.
• .Able to identify and document regulatory non-compliance and any issues involving subject safety..
• .Corneal refractive surgery experience is highly desired.

Contact [email protected] to learn more.

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