Senior Medical Writer

Regulatory Toolkit; Kennesaw (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

Artivion, Inc. in the Atlanta area seeks an experienced Clinical Regulatory Writer to prepare and maintain regulatory documents for medical devices, including CRs, CERs, PMCF, and SSCPs.

You will collaborate with physicians, CROs, and cross-functional teams to ensure timely submissions and compliant reporting. Requirements include 3–4 years in medical writing, a life science degree, and knowledge of clinical evaluation reports and post-market requirements.

Qualifications

• 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.
• Demonstrate computer skills (spreadsheet, relational databases).
• Excellent written and oral communication skills.
• Excellent interpersonal skills.
• Ability to manage multiple projects.

Responsibilities

• 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.

Skills

Regulatory writing

Clinical evaluation knowledge

Post-market requirements

Literature reviews

Excellent communication

Team collaboration

Project management

Education

Bachelor's or Master's in life sciences

Tools

Spreadsheets

Relational databases

Job description

Company Overview

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 four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 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. For additional information about Artivion, visit our website, www.artivion.com.

Responsibilities:

• 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.

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.
• Demonstrate computer skills (spreadsheet, relational databases).
• Excellent written and oral communication skills.
• Excellent interpersonal skills.
• Ability to manage multiple projects.