New job Clinical Affairs Associate Medical Writer – Clinical Evaluation Report (CER in Quebec

Clinical Affairs Associate Medical Writer – Clinical Evaluation Report (CER) Writer

Clinical Affairs Associate Medical Writer – Clinical Evaluation Report (CER) Writer
REMOTE OPPORTUNITY!

About US
At Vyaire, we help the world breathe easier. As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are a young company with a long history of revolutionary products. We devise extraordinary solutions that allow patients to lead ordinary lives. We believe the best way to create value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, building lasting relationships and making it a priority to listen. We are dedicated to anticipating what’s next and get it done. We thrive on contributing and making a difference.

To learn more, visit our website: www.vyaire.com
Watch our video: https://www.youtube.com/watch?v=ZDrQoMbMRrI&feature=youtu.be

About this role
Vyaire teams are dedicated to connecting clinicians and patients with the highest quality respiratory healthcare solutions in the market. At Vyaire, you will find a company that puts the customer at the center of all we do. Our culture is one that rewards performance and each interaction we have with a customer furthers our mission to be the global leader in respiratory care.
As a Clinical Affairs, Associate CER writer, you will be responsible for creating Clinical Evaluation documentation including CEP, CER and Literature review matrix. Your documentation will support regulatory submissions to obtain CE mark and maintain CE mark compliant to globally applicable regulations and standards, including MDD/MDR requirements.

Essential Functions:

• Responsible to author high quality, compliant documentation, edit, review, and format documents that conform to Vyaire process and procedure (Clinical Evaluation Reports [CER], Clinical Evaluation Protocols [CEP]) and internal document standards, while meeting project timelines.

• Assuming primary responsibility for the following tasks: create sorting spreadsheets from raw search data; perform initial screening to identify article type and perform inclusion/exclusion screening; review and summarize relevant medical articles for the State of the Art and Clinical Literature sections of the CER; perform searches on the Maude database for study and/or comparator devices; review raw post-market surveillance data and create tables and/or explanation; prepare literature search protocols and methodologies; and perform additional tasks as required to support Clinical Affairs deliverables.

• Attending meetings about document(s) in development and providing document status reports as needed.

• Collaborating with other CER writers to ensure continuous improvements to writing processes and for professional training.

• Support internal and external audits for CER compliance to MDD/MDR requirements.

• Required to attend PMS data review meetings, when applicable, to identify potential safety and/or performance risks or trends requiring consideration into the CER process.

• Analyses and evaluates results of literature reviews, product surveys, state-of-the-art determinations, product life-cycle clinical evidence gathering.

• Develop a strong working relationship with internal stakeholders to ensure compliance to global regulations and standards for source documents for clinical evaluation are met.

• Other duties as required.

Qualifications:
The ideal candidate will have the following qualifications and experience:

• Advanced degree in science, engineering, or medical field preferred.

• Basic understanding of regulations, standards, and guidelines related to medical devices clinical studies, and quality systems, including: 21 CFR (e.g., 803,812, 814, 820, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; MDR 2017/’745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485 preferred.

• Strong command of medical and surgical terminology.

• Strong computer skills, project management skills, problem solving skills and a high attention to detail.

• Excellent written English skills, able to accurately interpret data and express findings in a clear and concise written manner.

• Attention to detail—style, consistency, grammar, syntax, scientific accuracy.

• Knowledge and experience in internet research.

• Excellent project/time management and organizational skills and ability to work on own initiative.

• Comprehensive Microsoft Office skills, especially Word but also PowerPoint and Excel, and internet skills.

• Comfortable working in a regulated industry that demands tracking changes to regulatory requirements.

• Proficiency in IT application for centralized databases to track and monitor metrics.

• Effectively interface with the Quality Assurance, RA, and R&D partners.

• Experience dealing with government regulatory bodies, Competent Authorities, and Notified Bodies.

Atlanta, GA, Dallas, TX, Hartford, CT, Indianapolis, IN, Irvine, CA, Madison, WI, Mettawa, IL, Milwaukee, WI, Minneapolis, MN, Philadelphia, PA, Phoenix, AZ
Full time

Job Type: Full-time