Job Description

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 has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America.

The role involves working cross-functionally with internal stakeholdersincluding Clinical, Regulatory, R&D, and Quality teamsto ensure timely and compliant documentation in line with global regulatory requirements. Manage assigned departmental project tasks/systems in principal areas or responsibilities identified below.

Responsibilities include:

• Writing regulatory documents supporting clinical deliverables for product lines.
• Ensuring product line compliance with US and International regulations and standards, as applicable to clinical regulatory requirements, including document preparation and submissions.
• Coordinating deliverables for the CER, PMCF, and SSCP process for product lines.
• Collaborating with Clinical, R&D, Quality, Regulatory, Risk Management, Field Assurance, and Marketing.
• Effectively communicating timelines and assisting teammates in keeping them.
• Conducting literature reviews and writing research summaries related to product lines.
• Preparing product IFUs and assisting with labeling and labeling changes (including receipt of applicable translations).
• Collecting, querying, analyzing, distributing, and presenting clinical and pre-clinical data. Developing and maintaining any applicable clinical research databases, as necessary.
• Interfacing with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns.
• Generating interim and final clinical study reports.
• Communicating with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence.
• Coordinating the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature.
• Developing clinical protocols and/or investigational plans, informed consent forms, case report forms, handouts, SOPs, analyses, etc. as needed. Preparing status reports, as required.
• Performing literature reviews and reference management using tools such as PubMed and EndNote.
• Other assigned responsibilities (including previously identified tasks being performed at a higher level than one's current title).

Qualifications include:

• Bachelor's degree in life sciences, biomedical engineering, medical writing, or related field (advanced degree preferred: MS, PhD, PharmD, or MD).
• 25 years of medical writing experience in the medical device, pharmaceutical, or healthcare industry.
• Familiarity with regulatory documentation for medical devices and understanding of applicable regulations (EU MDR, FDA 510(k), etc.).
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to interpret complex scientific and clinical data.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and reference management software.

Preferred Qualifications:

• Experience with Class II or III medical devices.
• Familiarity with document management systems.
• Knowledge of systematic literature review methodology.
• Certification or training in medical writing (e.g., AMWA, EMWA) is a plus.

Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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