3-4 years of writing experience in the medical/biomedical industries.
BS or MS in biological science, epidemiology, engineering, statistics, or similar field.
Knowledge of medical device regulatory requirements, including Clinical Evaluation Reports and Post Market Requirements.
Skilled in writing and editing medical abstracts, white papers, and manuscripts.
Experienced in performing literature searches and analyses.
Proficient in computer skills including spreadsheets and databases.
Strong written and verbal communication abilities.
Outstanding interpersonal skills and capability to manage multiple projects.
Responsibilities
Support compliance with US and international product regulations and standards.
Write clinical regulatory documents such as annual reports and study rationales.
Assist with clinical requirements for regulatory submissions.
Coordinate deliverables for MDR compliance including CEP and CER activities.
Collaborate with teams across departments to achieve tasks.
Communicate project timelines and ensure accountability among team members.
Conduct literature reviews and produce research summaries on product lines.
Prepare product Instructions for Use (IFUs) and assist with labeling changes.
Present clinical data effectively and concisely.
Maintain clinical research databases as necessary.
Generate interim analyses and final clinical study reports.
Engage with physicians, vendors, and medical experts for insights.
Report on adverse events and failures related to product lines.
Oversee peer-reviewed projects and marketing literature execution.
Manage project timelines, budgets, and reporting for vendor-supported projects.
Benefits
Health, dental, and vision insurance offerings.
401k with company match for retirement savings.
Generous paid time off including holidays and vacation.
Professional development opportunities including training and certifications.
Flexible work environment promoting work-life balance.
Full Job Description
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.
