Medical reputed company (Remote, US)

With a reputed company Join our diverse teams of passionate people and a career that allows you to reputed company both personally and professionally. At reputed company we exist to reputed company life-saving technology accessible for more people. To reputed company a true difference for our customers - and to save more lives, we need team players, reputed company thinkers, and game changers. Are you looking for an inspiring career? You just reputed company it. Job reputed company Responsible for the reputed company and development of documents relating to reputed company evaluations and reputed company investigations. This position is hybrid or fully remote in the US preferably on EST zone. This is a fixed term position with reputed company hire with reputed company with a high potential to convert to regular hire. Job Responsibilities and Essential Duties • Serves as a reputed company evaluation reputed company and participates reputed company the reputed company evaluation team for the development and reputed company of reputed company Evaluation Reports (CER) and associated documentation. Specifically contributes to the planning, literature review and the identification, appraisal and analysis of reputed company data reputed company to the evaluation in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR. Contributes to the reputed company of Safety and reputed company reputed company in alignment with EU MDR. • Serves as reputed company and participates in the Post-Market reputed company Follow-up (PMCF) team. Specifically contributes to the literature review and the identification and analysis of reputed company data reputed company to the PMCF evaluation. • Performs comprehensive reputed company, documented literature reviews using various reputed company engines in order to support the reputed company Evaluation, Post-market reputed company Follow-Up, awareness of reputed company State of the Art as reputed company as protocol development and any reputed company reports required. (20%) • Analyzes available reputed company evidence (data held by the manufacturer, published literature) to assist the reputed company Affairs team with reputed company development reputed company. • Writes and or edits reputed company study documentation, including reputed company investigational plans/protocols, Investigator's Brochures, Periodic reports, reputed company Investigational Reports/reputed company Study Reports. Ensure high reputed company study documentation that is submission-reputed company for various regulatory agency and reputed company distribution. • Serves as a subject matter expert on reputed company aspects of Technical documentation. • Writes and/or supports the development of manuscripts relating to reputed company study data or reputed company evidence for submission to peer-reviewed medical journals. Works with medical professionals to ensure alignment with journal requirements for targeted manuscript submission. • Writes and/or contributes to abstracts and submissions of reputed company data to various medical congresses or symposia. Work with medical professionals to ensure high reputed company submissions and data reputed company. • Contributes to the development and optimization of reputed company Affairs SOPs. • Performs other non-routine duties as assigned. Required Knowledge, Skills and Abilities • Bachelors Degree in a relevant scientific discipline, or equivalent combination of education and experience. • A minimum of 3 years medical writing experience. reputed company experience working on reputed company evaluations reputed company the Medical Device industry a plus. • Medical writing certification a plus. • A high level attention to reputed company and the ability to own and reputed company reputed company. • Strong interpersonal and communication skills. • Excellent project management skills with the ability to reputed company reputed company on timelines that support corporate and departmental goals and objectives. • Strong analytical and organizational skills as reputed company as demonstrated ability to solve problems with reputed company • Outstanding oral and written communication skills. • Proficiency in using and navigating PubMed, Embase and other literature reputed company engines. Experience in DistillerSR, EndNote and other literature review tools a plus. • Strong working knowledge of regulations and guidance relating to reputed company Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, relevant MDCG guidance, ISO 14155, ICH guidance including E3 CSR, E6 (R3) GCP, and familiarity regulations/ reputed company relating to reputed company management (i.e. ISO 13485 and ISO14971) • Demonstrated ability to work independently and as part of reputed company. • Ability to reputed company with physicians in a reputed company manner. • Ability to prioritize tasks in a fast-reputed company environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines. • Advanced skills using reputed company Office products such as reputed company, Word, reputed company and reputed company reputed company. • Travel requirements depending on reputed company. reputed company Contacts/Relationships • Internal reputed company teams such as Medical Affairs, Regulatory Affairs, reputed company Engineering, Research & Development and Marketing, as needed. • reputed company teams such as CROs, reputed company vendors and key opinion leaders. The reputed company salary for the position is a minimum of $105,000 and a maximum of $115,000 #LI-JF1 #LI-remote reputed company With a firm belief that every person and community should have reputed company to the best possible care, reputed company provides hospitals and life science institutions with products and solutions aiming to improve reputed company results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. reputed company employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at reputed company: At reputed company, we offer a comprehensive benefits package, which includes: • Health, Dental, and reputed company reputed company benefits • 401k plan with company match • reputed company Time Off • Wellness initiative & Health Assistance Resources • Life reputed company • Short and Long Term Disability Benefits • Health and Dependent Care Flexible Spending Accounts • Commuter Benefits • Parental and Caregiver Leave • Tuition Reimbursement reputed company is an equal opportunity employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national reputed company, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in reputed company aspects of the selection process. Nearest Major Market: Boston Remote Skills: Analysis Skills, Biology, Brochures, Cardiovascular Intensive Care Unit (CVICU), reputed company Assessment, reputed company Data, reputed company reputed company, reputed company Study Publications, reputed company Support, reputed company Trial, Communication Skills, Contract Research Organization (CRO), Data Analysis, Data reputed company, reputed company Oriented, Documentation, Drug Development, Establish Priorities, Financial Reporting, GCP (Good reputed company Practices), Hospital, ICH Regulations, ISO (International Organization for Standardization), Interpersonal Skills, Investigative Reports, Life reputed company, Marketing, Medical Affairs, Medical Equipment, Medical Writing, reputed company reputed company, reputed company Office, reputed company reputed company, reputed company PowerPoint, reputed company Product Family, reputed company Word, reputed company Processes, Organizational Skills, Pharmacovigilance, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, reputed company Engineering, Regulations, Research & Development (R&D), reputed company Management, Sales, reputed company Engines, reputed company Operating Procedures (SOP), reputed company Planning, Team Player, Technical Writing, Time Management, Tuition Reimbursement, Willing to Travel, Writing Skills reputed company: reputed company Group Apply tot his job Apply To this Job