Medical Writer at R&Q - Regulatory and Quality Solutions
Medical Writing Talent Community – Remote
- MULTIPLE STATES
Welcome to the R&Q Solutions Talent Community! Our talent community is designed to be a network of candidates that are interested in potential future opportunities with R&Q. By joining a particular community, it lets us know your area of interest and allows you to receive targeted messages and new opportunity alerts. We remain committed to growing and engaging our talent network through these changing times and continuing our REMOTE interview process. We invite you to submit your information if you have an interest in learning more about our organization.
Providing world-class consulting services in a remote capacity is nothing new for R&Q Solutions as our consultant base is spread across 40 of our 50 beautiful states. As we navigate through uncharted territory, one thing that will remain consistent is the mission of R&Q Solutions: R&Q improves people’s lives. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities
We will be interviewing regulatory scientists/medical writers to support the development and creation of Clinical, Scientific, and Regulatory documents in accordance with procedures, European Medical Device Regulation, and US FDA requirements. This includes, conducting literature reviews, assisting and writing Clinical Evaluation Reports, analysis of product complaints and trends, collecting and analyzing feedback from various sources to support the CER.
PhD post doc candidates are encouraged to apply.
- Preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents.
- Performing literature reviews for specific medical devices.
- Strong medical and technical writing skills
- Knowledge and understanding of proposed and current global regulations and guidance and the ability to relay the impact of such regulations and guidance internally and with our clients.
- Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1 Rev. 4)
- Knowledge of clinical research and regulatory requirements
- 2+ years of experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation
- Or 3 – 5 year’s industry experience in medical writing in the healthcare industry or academia or in a related area such as quality, regulatory, clinical research, or product support.
- Experience with FDA and international regulations, requirements and guidance associated with clinical regulatory document preparations, submissions and reporting preferred
Being an industry leader in client support is just the beginning for R&Q. Providing a rewarding place to work is rooted deep in the core values of R&Q. From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the “and means more” approach to employment. At R&Q, you are not just another employee, you are a member of the R&Q family. Make your impact today!
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.
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