[Hiring] Medical Writer 2 @Cynet Systems

Role Description

The candidate will report to the Manager of Medical Science and will focus on supporting the in-house team with Clinical Evaluation Reports (CERs), with potential for future additional responsibility for development of other clinical evidence documents. The purpose of this role is to support CERs per Medical Device Regulation (MDR) to meet essential requirements in support of submissions for CE Mark applications to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication or labeling changes, as well as CER updates to maintain EU product conformance. Joining this team means being dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as the highest priority.

Responsibilities

• Authoring sections of clinical documentation as part of the Clinical Evaluation Reports (CER).
• Acquiring knowledge of therapeutic areas, literature review processes, and the ability to keep abreast of current literature.
• Participating in and performing comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.
• Working with the clinical librarian to assist with conducting literature searches on products and product families.
• Reviewing the scientific literature and critically appraising and writing clinical summaries for products and surgical procedures.
• Supporting internal team members by adhering to CER timelines and providing data in a timely manner to support global regulatory activities.
• Interacting with internal teams to understand the plan and strategy for development of the Clinical Evaluation Reports for new and existing products.
• Conducting proofreading, editing, document formatting, review comment integration, and document completion or approval activities.
• Assisting with the creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations, and posters based on clinical trials.
• Authoring protocols and routine clinical study progress reports.
• Ensuring compliance with corporate standard operating procedures and regulatory requirements, including GCP and US and OUS guidelines.

Requirements

• Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports.
• The candidate must have a minimum of 2+ years of medical writing experience.
• A minimum of 0-2 years of experience in clinical evaluation report writing in a medical device industry is preferred.
• Strong experience in conducting literature searches, reviews, and appraisal of scientific data.
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing.
• Excellent critical and analytical thinking skills.
• An MD, PhD, or M.S. degree in a scientific field is desired.
• High level of attention to detail and accuracy.
• Ability to work effectively with internal team members.
• Ability to manage multiple projects across numerous surgical disciplines.
• Strong communication, presentation, and interpersonal skills with high attention to detail and organization.
• Strong experience in protocol development and writing clinical sections for regulatory submissions.
• Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures.
• Dedication and a strong work ethic to help meet aggressive timelines or multiple projects when necessary.