Position Title:Medical Writer - EU/MDR
Location: Lewisville
Position Type: Full time
Req ID: OFX25490

Description:

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.

Medical Writer

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; and, perform other duties as assigned.

PhD degree in Biomedical Engineering or related field and 1 year of experience writing and developing clinical documentation, planning and developing clinical evaluation reports (CERs), clinical evaluation plans (CEPs) and summary of safety and clinical performance reports (SSCPs); working on clinical documents for global product registrations and continued market access; conducting systematic literature searches in PubMed, EMBASE, or other relevant platforms; and using citation management software.

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.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.

Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.

Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.

Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.

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