Senior Medical Writer
About The Position
Artivion, Inc., headquartered in suburban Atlanta, Georgia, is a medical device company dedicated to creating simple, elegant solutions for complex challenges faced by cardiac and vascular surgeons in treating aortic diseases. Our product portfolio includes aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. With over 1,600 employees globally and sales in over 100 countries, Artivion operates manufacturing facilities in Atlanta, Georgia; Austin, Texas; and Hechingen, Germany, supported by sales and distribution offices across Europe, Asia, and South America. More information is available at www.artivion.com.
Requirements
- Minimum 3-4 years of 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 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.
- Demonstrated computer skills (spreadsheet, relational databases).
- Excellent written and oral communication skills.
- Excellent interpersonal skills.
- Ability to manage multiple projects.
Responsibilities
- Support product line compliance with applicable US and International regulations and standards.
- 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 CEP, CER, PMCF activities, and the SSCP process for MDR compliance.
- Collaborate with other departments to achieve team goals.
- Effectively communicate timelines and ensure team members adhere to agreed-upon project schedules.
- Conduct literature reviews and write research summaries related to the product line.
- Support the preparation of product IFUs and assist with labeling and labeling changes, including obtaining necessary translations.
- Effectively 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 on adverse events, complaints, and product failures identified during 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 for vendor-supported projects.
- Generate clinical study documents, including but not limited to: protocols, investigational plans, informed consent forms, handouts, SOPs, and status reports.
- Act as a liaison between Artivion, investigational sites, and CROs (as applicable) to coordinate and document final reports and publications.
- Perform other assigned responsibilities, including executing previously identified tasks at a higher level.
- Support the development of clinical regulatory documents for product maintenance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
