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Since these are all work from home, freelance, contract and telecommute jobs, you can be based anywhere and still apply, providing you meet the employer's requirements. However, there are times when the employer will ask for applicants from a specific location, this will be clearly stated in the job posting below.

Title: Medical Scientific Writers - Medical Device Industry
Date Posted: 2018-01-02
Location: Not mentioned
Job Summary:

Make your impact today and join the R&Q Team. We are looking for Medical Writers with CER experience. These positions can be remote - and we are seeking talent nation-wide.

We are seeking 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.

Responsibilities include:

- 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 ablity 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)
- Knowledge of clinical research and regulatory requirement

Key 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.


Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Work Environment/Physical Demands

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.

We currently have a variety of options available (full time roles; freelance roles; remote work and onsite work).

Apply via this link only:

keywords: medical scientific writer, writer, full time


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Company: Regulatory and Quality Solutions LLC (R&Q)
Contact person: Not mentioned
Contact information: info@rqteam.com (DO NOT APPLY VIA THIS EMAIL ADDRESS)