Medical Writer

RIVERPOINT MEDICAL LLC•Portland, OR

About The Position

Riverpoint Medical in Portland, Oregon is looking to hire a Medical Writer. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Medical Writer will possess an understanding of regulatory requirements for clinical and post market evaluations to support Riverpoint Medical product registration efforts in the EU market. The candidate will lead clinical and post market evaluation writing activities and work closely with other departments and functions to ensure the development of high-quality documents in alignment with project timelines and priorities.

Requirements

Advanced degree (Master's or PhD) in scientific or medical discipline.
2-3 years’ experience writing clinical evaluation reports, periodic safety update reports, or other EU MDR clinical and/or post market evaluations.
Experience and skill performing systematic medical/scientific literature searches (PubMed, Google Scholar, EMBASE, etc.)
Excellent writing skills and the ability to communicate correctly and persuasively in English and to use medical terminology accurately.
Ability to manage multiple projects, interact with multi-disciplinary teams, and work independently with minimal supervision.
Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users.
Knowledge of narrative and systematic literature reviews; accuracy with interpretation and ability to concisely present data is a must.

Responsibilities

Perform clinical evaluation, including planning, identification, appraisal, analysis, and reporting of clinical data. Prepare and update European Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files as required and per applicable SOPs. Ensure compliance with the applicable regulations and guidance documents.
Coordinate with various departments (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to assess and identify the necessary preclinical, clinical, and technical information.
Perform gap analyses and revise existing CERs for legacy products against the EU Medical Device Regulation.
Generate and track timelines. Follow through on all tasks and ensure quality results.
Develop or revise templates, SOPs, or guidelines for regulatory, medical, and clinical documents.
Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies.
Participate in post-market surveillance activities by leading routine systematic literature reviews (e.g., screen articles against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for specific medical device groups or sub-groups.
Organize and incorporate information, such as references, graphics, tables, and data listings, for the creation of robust and compliant technical documents.
Critically write and edit scientifically complex documents with substantial intellectual content.
Maintain knowledge of current internal and external standards, regulations, and technologies related to this function.