Orthofix logo
Orthofix

Orthofix transforms patient lives worldwide through medical technologies that heal musculoskeletal pathologies.

Medical Writer

Medical writerMedical writerFull TimeRemoteMid LevelTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

18 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

Medical Writer

Orthofix

Role Description At Orthofix, we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. We seek team members who build relationships, share knowledge, challenge the status quo, and deliver results to help us achieve our vision to be the unrivaled partner in Med Tech. Job Duties: - Review medical scientific literature, analyze clinical risk and provide benefit/risk assessments. - Write, review, and edit Clinical Evaluation Reports (CERs) to comply with international regulations. - Write and update coherent and convincing CERs and Post-Market Clinical Follow-up (PMCF) Reports by organizing and evaluating large amounts of scientific/clinical/medical data. - Prepare and update Summary of Safety and Clinical Performance (SSCPs) according to the SOP, based on the CER and other sources, including the part for lay persons. - Write and update Clinical Evaluation Plans (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 Instructions for Use (IFU) and Periodic Safety Update Reports (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. Telecommuting permitted from anywhere in the U.S. Qualifications - PhD degree in Biomedical Engineering or related field. - 1 year of experience writing and developing clinical documentation. - 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. Requirements - PhD degree in Biomedical Engineering or related field. - 1 year of relevant experience. Job Location Lewisville, TX (Telecommuting permitted from anywhere in the U.S.) Disclaimer The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status. Equal Employment Opportunity We are committed to providing equal employment opportunities to all employees and applicants without regard to protected status in accordance with all applicable federal, state, and local laws.

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