Medical Writer

Location

Burlington, MA | United States

Job description

The Medical writer will need to be able to write scientific and regulatory documents of different types. The primary focus will be on writing and updating Clinical Evaluation Reports and the supporting documents. Other writing will focus on regulatory and research-related documents, disease or device-related promotional literature, publication articles like journal manuscripts and abstracts. The scientific information in these documents needs to be presented to suit the level of understanding of the target audience, namely, patients or general public, physicians or the regulators. The position requires someone with an understanding of the medical concepts and terminology surrounding peripheral vascular conditions and cardiac repair. Knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills is also required. The candidate should also be familiar with searching medical literature, understanding and presenting research data, the document review process, and editing and publishing requirements.

• Update Clinical Evaluation Plans and Reports for all medical devices MEDDEV 2.7/1 rev 3 (2009), rev 4 (2016), AIMD(2017), and MDR (EU) 2017/745 (2020).
• Support in updating regulatory documents such as Summary of Safety and Clinical Performance, Periodic Safety Update Report, PMCF Plan/Report
• Transitioning CERs from MDD to MDR
• Support protocol writing

• Masters degree in relevant field. Ph.D. preferred 
• At least 9-years experience in writing Clinical Evaluation Reports, including updating and writing literature search protocols and Clinical Evaluation Protocols
• Extensive knowledge in Peripheral - Vascular conditions and treatments
• Knowledge Cardiology Endovascular - AAA/TAA Repair
• Experience in protocol writing

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.

This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.

Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at [email protected].

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