The Clinical Evaluation Scientist will be responsible for developing, writing, and/or completing clinical/regulatory documents, including Clinical Evaluation Reports (CERs), Clinical Evaluation Plans, etc on behalf of Bannick LLC for a variety of clients. The Clinical Evaluation Scientist will utilize clinical data, published literature, clinical investigation results, and field performance data in order to evaluate the product safety and performance. The Clinical Evaluation Scientist has experience and understanding in clinical research and regulatory guidelines.
Essential Duties and Responsibilities:
- Provide scientific and/or medical expertise, analytical thought processes and a robust, systematic clinical evaluation approach in order to continuously collect, analyze and assess clinical data.
- Prepare CERs and related evidence deliverables (Clinical Evaluation Plans, Post-market Clinical Follow-up (PMCF) Plans, and others) for medical devices in compliance with client SOPs, templates and applicable clinical and regulatory standards.
- Analyze pre-clinical data, risk management assessments, published literature, clinical investigation results and field performance data in order to evaluate product safety and performance.
- Analyze and document data from clinical publications.
- Work with the literature search representative to conduct literature searches on various products/product families. Use of EndNote preferred.
- Ensure compliance to Bannick LLC and client specific SOPs and all related regulatory requirements.
- Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities. Use of PerfectIt preferred.
- Ability to work independently with minimal supervision.
- Other duties as assigned by management.
- Advanced Degree in biological or medical science is required or equivalent education and experience with demonstrated ability to perform the essential functions of the job may be considered.
- Minimum 2 years technical writing or clinical evaluation reporting experience within the medical device industry is preferred.
- Familiarity with current regulatory agency guidance and regulations, including FDA, EU MDR and MEDDEV Rev 4.
- Demonstrated writing capability and critique of clinical and regulatory documentation.
- Expert level knowledge of Microsoft Office products, in particular Word.
- Proficient in citation manager software, e.g. EndNote.
- Ability to work remotely.
- Excellent communication and interpersonal skills, ability to establish and maintain effective communication with colleagues and clients.
- Previous experience in the application of in-depth therapeutic and device knowledge to development of CERs preferred.
- Proficient knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states.
- Excellent time management skills.
Job Types: Full-time, Part-time
Pay: $63,000.00 - $80,000.00 per year
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
- Referral program
- Vision insurance
- 8 hour shift
- Monday to Friday
- How many years of Microsoft Office experience do you have?
- How many years of Medical Device experience do you have?
- How many CERs have you authored?
- Do you have a non-compete in place with any employer that would impede your ability to work at Bannick?
- Can you start immediately?
- Bachelor's (Required)
- Clinical Evaluation Report writing: 2 years (Required)
- Fully Remote
Hours per week:
This Job Is:
- A job for which military experienced candidates are encouraged to apply
Company's Facebook page:
- Remote interview process
- Virtual meetings
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