Senior Analyst, Medical Writing, Clinical

2 semanas atrás


Teresina, Brasil Remote Jobs Tempo inteiro

Employer Industry: Healthcare Innovation Why Consider this Job Opportunity: Salary up to $147,200 Opportunity for participation in the Company’s long-term incentive program Comprehensive benefits including medical, dental, vision, life insurance, and retirement plans Generous paid time off, including vacation, sick leave, and parental leave Work remotely anywhere within the continental U.S. Chance to contribute to innovative solutions in the field of cardiovascular health What to Expect (Job Responsibilities) Plan, prepare, and finalize regulatory documents focused on global post-market surveillance requirements Conduct literature and clinical data reviews to support regulatory document preparation Collaborate with cross-functional teams for document planning and review Ensure regulatory documents comply with FDA, EMA, and company standards Stay updated with regulatory guidelines and industry trends in medical writing What is Required (Qualifications) Minimum of Bachelor's degree (BS/BA) required; advanced degree preferred At least 4 years of relevant scientific/med tech experience required Minimum of 3 years of medical writing experience required Authoring experience with clinical evaluation reports and post-market surveillance documents required Strong knowledge of FDA and EU MDR regulations and post-market requirements How to Stand Out (Preferred Qualifications) Clinical research experience strongly preferred Experience in the cardiovascular disease area preferred Background in science or engineering preferred Exceptional ability to summarize and present complex clinical and scientific information We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer. #J-18808-Ljbffr


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