Technical Medical Writer

Argon Medical Devices 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.

Outstanding opportunity for a Technical Medical Writer

What you will do:

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.
• 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.
• 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 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.

Skills for Success:

• 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.
• Must have excellent writing skills and the ability to communicate correctly and persuasively in English, and to use medical terminology accurately.
• Requires in depth working knowledge of Microsoft Office Products and ability to manage multiple projects, interact with multi-disciplinary teams, and work independently with minimal supervision.
• Ability to quickly acquire and apply understanding of therapeutic areas, medical device portfolios, business objectives, technical skills, clinical data/evidence.
• Good problem-solving and analytical skills. Proactive approach to minimize the impact to projects.
• Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
• Understanding of current regulatory and clinical requirements governing medical devices, including but not limited to: 21 CFR (e.g., 803, 812, 814, 820, 822, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; EU MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
• Experience writing CERs according to MEDDEV 2.7/1 Rev 4, highly preferred.
• Understanding of European clinical requirements, including EU MDR and MEDDEV 2.7.1, highly preferred.
• Creativity with interpretation and presentation of data an asset.

Argon Medical is an equal opportunity employer and complies with anti-discrimination laws. We believe that inclusion and diversity fosters creativity, innovation, and empowers all our employees which makes us a stronger organization overall. We promote a culture that maintains a balanced and diverse workforce.