Job Description

Primary Function of Position This position reports to the Manager, Medical Science and requires a strong candidate with experience in medical writing of clinical regulatory documents. The position will mainly focus on supporting the in‑house team with the Clinical Evaluation Reports (CERs), with potential for future additional responsibility for development of other clinical evidence documents. The purpose of this job is to support clinical evaluation reports (CERs) per Medical Device Regulation (MDR) in order to meet essential requirements for CE Mark application, Declaration of Conformity and EU market clearance, recertification, proposed indication/labeling changes, and CER updates to maintain EU product conformance. Roles and Responsibilities Author sections of Clinical documentation as part of the Clinical Evaluation Reports (CER). Acquire knowledge of therapeutic areas, literature review processes, and remain current on the latest scientific literature. Participate in and/or perform comprehensive literature searches to develop in‑depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies. Work with the clinical librarian to help conduct literature searches on products and product families. Review the scientific literature, critically appraise it, and write clinical summaries for products and surgical procedures. Support internal team members by adhering to CER timelines and providing data in a timely manner to support global regulatory activities. Interact with internal teams to understand the plan and strategy for development of the Clinical Evaluation Reports for new and existing products. Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities. Assist with the creation of clinical content, including manuscripts, scientific abstracts, conference presentations, and posters based on Intuitive clinical trials. Author protocols and/or routine Clinical Study Progress Reports. Ensure compliance with corporate SOPs and regulatory requirements (e.g., Google Cloud Platform, US and OUS guidelines). Skill/Job Requirements – Competency Requirements Competency is based on: education, training, skills and experience. In order to adequately perform the responsibilities of this position the individual must: Possess previous experience applying therapeutic and device knowledge to support the development of clinical evaluation reports. Have a minimum of 2–4 years of medical writing experience. Have 0–2 years of experience in clinical evaluation report writing in a medical device industry (preferred). Have strong experience conducting literature searches, reviews, and appraisal of scientific data. Demonstrate the ability to communicate clearly and effectively, both verbally and in technical or scientific writing, with strong scientific writing skills. Exhibit excellent critical and analytical thinking skills. Hold an MD, PhD, or M.S. degree in a scientific field (desired). Maintain a high level of attention to detail and accuracy. Work effectively with internal team members. Manage multiple projects across numerous surgical disciplines. Display strong communication, presentation, and interpersonal skills with high attention to detail and organization. Have strong experience in protocol development and writing clinical sections for regulatory submission. Show the ability to learn quickly and self‑educate on different surgical specialties as applicable to medical products and procedures (self‑starter attitude). Consistently demonstrate dedication and a strong work ethic to meet aggressive timelines or handle multiple projects when necessary. We are an AA/EEO/Veteran/Disabled employer. #J-18808-Ljbffr DGN Technologies

Job Tags

Similar Jobs