PhD Medical Writers

RQM+ is the largest medical device and diagnostics focused full-service regulatory and quality consulting firm in the world. 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. Being an industry leader in regulatory and quality consulting is just the beginning for RQM+. We consider our Associates our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! PhD Medical Writer We have a unique opportunity for PhD candidates who are wanting industry experience. Our consulting services team offers a training program for PhDs who are looking to get industry experience. These positions are REMOTE BASED, candidates must reside in the U.S. We have a training program especially geared for PhDs and currently have a large team of those who have successfully completed the program. This role will start as a Contract position, for a 6-12 month duration. This is an opportunity to break into a very high demand field without experience and be trained by subject matter experts. Our CER Writers work with a dedicated team serving Medical Device company clients. Responsibilities: • 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 Requirements: • Fellowship or working experience in clinical research. • Must have extensive experience in state of the art literature reviews. • Must have a current publications list to share. • Have had exposure with the FDA and international regulations, requirements and guidance associated with clinical regulatory document preparations, submissions and reporting preferred. We are interested in every qualified candidate who is eligible to work in the United States as a permanent resident. However, we are not able to sponsor visas.