The medical writer is primarily responsible for preparing Clinical Evaluation Reports (CERs) and associated documents for regulatory submissions and Post-market Surveillance for analysis of existing product clinical performance, while working in a cross-functional team. This includes conducting searches of peer-reviewed publications, risk management files and post market quality tabulations to compile relevant data. Report preparation involves summarizing data and writing risk versus benefit analyses for products in a format defined to satisfy regulatory requirements. The medical writer may also prepare technical documents, study protocols, investigational plans, manuscripts for publication, or white papers. The scope includes AirLife anesthesia and respiratory medical devices.

Principal Duties and Responsibilities:

• Develop Clinical Development Plan as part of design validation for new medical devices to support product registrations internationally
• Prepare Clinical Evaluation Plan (CEP) & Clinical Evaluation Report (CER) documents in accordance with European Union guidance using relevant information compiled from clinical research, peer reviewed publications, risk management files and post market data. This will also include project management of CER or Post Market Surveillance (PMS) activities in collaboration with quality and regulatory organization
• Maintain periodic updates, perform gap analysis, and revise existing CERs to meet current international regulations
• Collaborate with the Quality, Engineering & Regulatory Affairs organization and perform Clinical Risk Benefit Analysis (CRBAs) to support risk management activities
• Collaborate with Regulatory Affairs and provide support to respond to clinical questions from regulatory agencies
• For all documents, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers
• Conduct scientific literature searches and clinical evidence mapping, manage the literature database, and prepare literature reviews for external and internal stake holders
• Participate in the periodic reviews of recent scientific publications and online content relevant to the business, draft article summaries for distribution to key stakeholders
• Develop and maintain SOPs and writing tools, such as templates and style manuals

• May attend conferences to keep current with advancements in the field; contribute to the development of conference coverage reports for internal distribution
• Develop and create clinical study protocols, protocol amendments, informed consent forms, case report forms, and study reports (e.g., human factors testing, user preference evaluations, performance bench studies.) in support of the Clinical Affairs department and in coordination with Regulatory Affairs and Engineering
• Performs other duties and task for Clinical Affairs, as required

 Skills

• Strong verbal, written, and interpersonal communication skills
• Demonstrated bibliographic research and editorial skills
• Strong organizational skills, attention to detail and proofreading skills
• Strong ability to interpret and disseminate results of published literature and clinical studies, working knowledge of statistics
• Basic understanding of regulatory compliance for medical device
• Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
• Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) 
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment
• Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases
• Project management skills

Education/Experience Requirements:

• BS/BA in respiratory therapy, nursing or a similar technical discipline preferred.
• Three or more years of experience as a medical or clinical research writer, or an equivalent combination of education and experience.
• Minimum of one-year experience of authoring Clinical Evaluation Reports to the EU MDR Regulation 2017/745.
• Clinical background in the medical device industry desired, with a strong preference to those with experience in the respiratory and anesthesia products

Experience:

• 3 years of medical writing required
• 3 years working in the medical device industry 
• 3 years of literature search required
• Bachelor's Degree required, Master preferred

Travel: up to 20%