Senior Medical Writer (Remote)
CryoLife
- Kennesaw, GA
- Permanent
- Full-time
- 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.
- 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.