Senior Medical Writer

🕒 August 24

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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Artivion, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1984

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

Artivion, Inc. is a medical technology company focused on developing, manufacturing, and commercializing aortic- and cardiac-centric surgical devices and biomaterial products. The company produces heart valves (On-X), aortic arch and thoracoabdominal stent graft systems, hybrid prostheses (AMDS), cryopreserved allografts and tissues, surgical adhesives (BioGlue), and ancillary vascular and cardiac surgical tools. Artivion works with cardiac and vascular surgeons and conducts clinical trials and regulatory submissions to advance device safety and efficacy, serving hospitals and surgical centers globally.

📋 Description

• Support product-line compliance with applicable US and international regulations and standards • Write clinical regulatory documents, including annual reports, study summaries, and study rationales • Support clinical requirements for regulatory submissions and product maintenance • Coordinate deliverables including CEP, CER, PMCF activities, and SSCP processes for MDR compliance • Coordinate company deliverables and hold team members accountable to project timelines • Conduct literature reviews and write product-related research summaries • Support preparation of product IFUs and assist with labeling changes and translations • Present and share clinical data • Develop and maintain applicable clinical research databases • Generate interim analyses, investigator meeting slides, and final clinical study reports • Communicate with physicians, vendors, and other medical experts • Report adverse events, complaints, and product failures identified through the writing process • Coordinate peer-reviewed projects, including publications, posters, abstracts, and marketing literature • Oversee timelines, budgets, budget change forms, accruals, and monthly reports for vendor-supported projects • Generate clinical study documents, including protocols, investigational plans, informed consent forms, handouts, SOPs, and status reports • Liaise between Artivion, investigational sites, and CROs to coordinate and document final reports and publications • Perform other assigned responsibilities, including tasks performed at a higher level than the current title

🎯 Requirements

• Minimum 3-4 years’ experience writing within the medical/biomedical industry • BS or MS degree in biological science, epidemiology, engineering, statistics, or another science-related field • Knowledge of regulatory requirements for medical devices, including Clinical Evaluation Reports and Post Market Requirements • Ability to write and edit quality medical abstracts, white papers, manuscripts, and other educational materials • Experience with literature searches and analysis • Computer skills, including spreadsheets and relational databases • Excellent written and oral communication skills • Excellent interpersonal skills • Ability to manage multiple projects

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities