Medical Writer
About The Position
Why Orthofix? Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.
Requirements
- PhD degree in Biomedical Engineering or related field
- 1 year of experience writing and developing clinical documentation
- 1 year of experience planning and developing clinical evaluation reports (CERs), clinical evaluation plans (CEPs) and summary of safety and clinical performance reports (SSCPs)
- Experience working on clinical documents for global product registrations and continued market access
- Experience conducting systematic literature searches in PubMed, EMBASE, or other relevant platforms
- Experience using citation management software
Responsibilities
- Review medical scientific literature, analyze clinical risk and provide benefit/risk assessments, write, review, and edit CERs to comply with international regulations
- Write and update coherent and convincing CERs and PMCF Reports by organizing and evaluating large amounts of scientific/clinical/medical data
- Prepare and update SSCPs, according to the SOP, based on the CER and other sources, including the part for lay persons
- Write and update CEPs and PMCF plans
- Work collaboratively with cross-functional partners
- Prepare answers to Notified Body or Regulatory Agency requests
- Assist with other clinical, marketing, and regulatory projects as assigned (including: preparation of IFU and PSUR)
- Acquire, interpret, analyze, and draw conclusions from clinical data from clinical trials, literature, and experiences for a wide variety of medical devices
- Communicate scientific content in a clear and concise manner
- Mentor and train new incoming team members about procedures and best practices
- Perform other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
