Technical Medical Writer

Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas.  Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology.  Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures.  Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture.  Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

The Medical writer provides scientific/regulatory guidance and technical expertise in the writing, production, and review of regulatory and other scientific/clinical documents to suit the level of understanding of its target audience. This position provides interpretation and analysis of clinical and non-clinical data pertinent to scientific communications projects (e.g., literature reviews, Clinical Evidence Reports, and post-market clinical summaries). Serves as medical writer on clinical study or regulatory project teams, as assigned. Plans and coordinates report-writing activities with dependent staff roles to ensure satisfactory completion of assigned writing projects.

• Manage and maintain project milestones and writing activities to align with business goals.
• Coordinates with various departments (e.g., Regulatory, R&D, Post-Market Experience, and Quality) to access and identify the necessary preclinical, clinical and technical information.
• Coordinate external medical writing support/needs, as applicable.
• Manage, prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files/dossiers/registrations, as required and per applicable SOPs.
• Manage internal NPD and consultant/ vendor relationships related to completion of clinical evaluation reports.
• Ensure compliance to the applicable regulations and guidance documents.
• Perform gap analyses and revise existing CERs for legacy products against the Medical Device Regulation.
• Working with a multifunctional team, authors assigned protocols, final study reports, manuscripts for publication in peer-reviewed biomedical journals, meeting abstracts, internal reports, and presentations.
• Generate and track timelines. Follows through on all tasks and ensures quality results.
• May develop or revise templates, SOPs, or guidelines for regulatory/medical/clinical documents.
• Conduct scientific literature reviews and compile reports such as annual literature updates to global regulatory agencies, as required.
• Participates in post-market surveillance activities by leading routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
• Organizes and incorporates information, such as references, graphics, tables, and data listings for the creation of large, technical documents.
• Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
• Maintains knowledge of current internal and external standards, regulations and technologies related to this function.  

• Bachelor’s degree (advanced degree preferred) in the sciences, a medical-related field, or medical/technical writing.
• 2+ years of experience in a regulated healthcare environment (ISO 13485:2016/ and 21CFR 820), the medical device industry is preferred.
• Knowledge in narrative and systematic literature reviews required.
• Excellent understanding of scientific or clinical research and methods required.
• Proficiency in MS Outlook, Word, Excel, and PowerPoint.
• Travel may be required (up to 15%)