Senior Medical Writer

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s products include aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. With over 1,600 employees worldwide, Artivion has sales representation in over 100 countries and manufacturing facilities in Atlanta, Georgia; Austin, Texas; and Hechingen, Germany.

Responsibilities

• Support product line compliance to US and International regulations and standards as applicable.
• Write clinical regulatory documents including annual reports, study summaries, and other study rationales.
• Support clinical requirements for regulatory submissions and maintenance.
• Coordinate company deliverables such as the CEP, CER, PMCF activities, and SSCP process for MDR compliance.
• Collaborate with other departments to accomplish tasks and effectively communicate timelines.
• Hold team members accountable to agreed-upon timelines required for project dates.
• Conduct literature reviews and write research summaries related to the product line.
• Support preparation of product IFUs and assist with labeling and labeling changes (including translations).
• Effectively present and share clinical data.
• Develop and maintain clinical research databases as necessary.
• Generate interim analysis, investigator meeting slides, and final clinical study reports.
• Communicate with physicians, vendors, and other medical experts.
• Report on adverse events, complaints, and failures associated with the product line identified through the writing process.
• Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature.
• Oversee project timelines, budgets, budget change forms, accruals, and monthly reports associated with 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 at a higher level than one’s current title.
• Support the development of clinical regulatory documents to support product maintenance.

Qualifications

• Minimum 3-4 years’ experience writing within the medical/biomedical industry.
• BS or MS degree in biological science, epidemiology, engineering, statistics, or other science-related field.
• Knowledge of regulatory requirements relative to 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.
• Demonstrated computer skills (spreadsheet, relational databases).
• Excellent written and oral communication skills.
• Excellent interpersonal skills.
• Ability to manage multiple projects.