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Senior Medical Writer
Artivion, Inc.Senior Medical Writer at Artivion developing clinical regulatory documents for medical devices. Collaborating across departments and ensuring compliance with regulations for product maintenance.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Evaluation ReportsPost Market RequirementsMedical Abstract WritingStatistical AnalysisDatabase Management
Soft Skills
Interpersonal SkillsProject ManagementTeam Collaboration