Artivion, Inc.

Medical writer

• Support product line compliance to US and International regulations and standards as applicable
• Writing clinical regulatory documents including annual reports, study summaries, and other study rationales.
• Support clinical requirements for regulatory submissions and maintenance.
• Coordinating company deliverables such as but not limited to the CEP, CER, PMCF activities and SSCP process for MDR compliance
• Collaborate with other departments to work as a team to accomplish tasks
• Effectively communicate timelines and hold team members accountable to agreed upon timelines required for project dates.
• Conduct literature reviews and write research summaries related to product line.
• Support preparation of product IFUs and assist with labeling and labeling changes (including receipt of applicable translations).
• Effectively present and share clinical data.
• Develop and maintain any applicable 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 but not limited to: protocols, investigational plans, informed consent forms, handouts, SOPs, and status reports.
• Liaison between Artivion, investigational sites, and CROs (as applicable) to coordinate and document final reports and publications.
• Other assigned responsibilities (including previously identified tasks being performed at a higher level than one's current title).
• Support the development of clinical regulatory documents to support product maintenance.

Senior Medical Writer

Data Scientist

• Lead, manage, execute end-to-end data management activities for clinical trials conducted inhouse or outsourced to CRO’s.
• Develop and maintain Data Management Plans (DMPs), CRFs, edit check specifications, and other essential documents.
• Oversee database build. Testing, validation, and UAT processes in EDC systems.
• Ensure timely and high-quality data collection, cleaning, reconciliation, and database lock activities.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendors.
• Ensure data integrity and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standards.
• Participate in and contribute to protocol development, case report form design, and data flow diagrams.
• Conduct and oversee data reconciliation, external data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD).
• Provide study specific reports and data listings on regular basis and for ad-hoc requests.
• Support audit readiness and participate in regulatory inspections when required.
• Mentor junior team members and provide strategic input into department process improvements and SOP development.

Senior Clinical Data Manager

Therapist

• Provide on-call technical and clinical support to investigators at assigned sites during patient screening, case planning, and device selection
• Coordinate and support investigator meetings and on-site training of study sites
• Ensure adequate investigational device inventory and facilitate device orders throughout enrollment
• Complete any required clinical reports and documentation in a timely manner
• Support any required CT imaging evaluation (via EndoSize) for aortic arch technologies
• Gather investigator feedback on device performance after procedures and immediately report any applicable product failures, performance issues, or customer complaints
• Design, develop, and execute national and local education strategies for the US sales team
• Design, develop, and execute surgeon training and engagement programs in the US

Senior Medical Writer

Senior Clinical Data Manager

Manager, Therapy Development