![]() * Interpersonal/verbal/written communication skillsĪs an eligible Merit employee, you can expect the following: * CER protocol and report development/writing * Demonstrated computer skills preferably spreadsheets, word processing, internet research and other applicable software programs. * Self-motivated, self-directing, strong attention to detail and excellent time management skills. * Strong command of medical and surgical terminology. * Effective written and verbal communication skills in the area of technical/clinical applications. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), EU Medical Device Regulation (2017/745) and ISO 13485 Quality System Standards. * Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information and complex documents. * Proficient in searching medical literature and databases for clinical and technical information. * Extensive knowledge of regulatory requirements relative to Clinical Evaluation Reports. * Education and/or experience equivalent to a Bachelor's Degree in the medical, biological, physical or engineering disciplines and five years of medical writing experience, preferably with CERs. Performs other duties and tasks, as required. May supervise or mentor other medical writers, as assigned.ġ1. Conducts training for medical writers, regulatory affairs and other functions, as needed.ġ0. Creates and manages schedule of deliverables.ĩ. Provides input to post-market surveillance and risk management activities.Ĩ. Develops and maintains in-depth therapeutic and product operation knowledge applies this knowledge to the development of well written clinical evidence documents.ħ. Collaborates with cross-functional teams to ensure high quality and successful project delivery.Ħ. Manages and maintains the procedures, systems and processes required to meet regulatory requirements for clinical evidence documents and ensures they stay up-to-date based on guidance, regulation and feedback from regulators.ĥ. Supports regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions.Ĥ. Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.ģ. ![]() Independently researches, prepares, writes, edits and reviews clinical evidence documents, e.g. The primary focus will be on Clinical Evaluation Reports (CERs) and Summaries of Safety and Clinical Performance (SSCPs).ġ. Also responsible for the maintenance of the related procedures, systems and processes. Responsible for supporting the development and creation of clinical, scientific and regulatory documents in accordance with procedures, European Medical Device Regulations, and US FDA requirements. This is a remote opportunity for candidate living anywhere in the US, east or west coast, with preference to candidates living in Cplorado or Utah. Merit Medical is lookng for a Senior Medical Writer for their Medical Affairs Division. Together, we are making a difference in the lives of patients around the world. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. At Merit Medical, our mission is to create innovative medical devices that improve lives.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |