Senior Medical Writer

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
• 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
• Coverage 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
• 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