BD (Becton, Dickinson and Company) Clinical Scientist in Covington, Georgia

Job ID: 2018-12673

Career Level: experienced

Relocation: no

Location: Covington,Georgia,United States

Overview:

Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Clinical Scientist in Covington, GA.

Summary of Position with General Responsibilities:

This position reports to the Senior Clinical Scientist. The Clinical Scientist is responsible for performing, preparing, and maintaining clinical evaluations for CE technical documentation in accordance with the requirements of ISO 14155 and MEDDEV.2.7.1, and EU MDR. This primarily involves analyzing available safety and performance data for a medical device (e.g., from clinical trials, published literature, etc.) and preparing technical reports (Clinical Evaluation Reports) to demonstrate the device’s technical and clinical performance. In addition, the Clinical Scientist will participate in Post-Market Surveillance and R&D projects as the Clinical Representative.

Essential job Functions:

  1. Participate as the Clinical Representative in Post-Market Clinical Surveillance

  2. Author Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for technical documentation ensuring compliance with applicable regulations (e.g., MEDDEV 2.7.1, ISO 14155, EU MDR, etc.) and company procedures.

  3. Collaborate with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives.

  4. Responsible for ensuring that assigned plans and reports are self-checked for errors, grammar, accuracy before approval, and that documents are routed correctly in the document control process.

  5. Responsible for following up on approvals of documents and ensuring that the CERs are released in the electronic document system timely.

  6. Obtain required approvals and ensure that Clinical Evaluations remain current according to the required update schedule.

  7. Participate in work streams and or process improvement initiatives.

Education and/or Experience:

  • This position requires a minimum of a bachelor’s degree in a clinical/medical discipline (e.g., RN, PA, etc.).

  • A Master’s Degree, Medical Doctor, or Doctor of Philosophy in a clinical/medical discipline is strongly preferred.

  • Associate Clinical Scientist requires a minimum of 4 years of experience in clinical, scientific research, medical writing, or medical device industry or a combination of education and experience.

  • Clinical Scientist requires a minimum of 6 years of experience in clinical, scientific research, medical writing, or medical device industry or a combination of education and experience.

  • This position requires demonstrated experience in high quality medical/technical writing and excellent written and oral communication skills.

  • Prior experience performing clinical evaluations according to MEDDEV 2.7.1 and EU MDR, and systematic literature reviews is strongly preferred.

  • This position does not require travel.

Physical Demands:

This position requires the ability to perform activities consistent with general office/administrative work.

Work Environment:

This position is based in a general office/administrative environment. This position also requires proficiency with general office computing software (e.g., MS Outlook, MS Word, MS Excel, etc.)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status