Senior Medical Writer

Medical Writer IVDuration: 6-12 months from the start date of the worker with possibility to extend contractLocation: St. Paul, MN; Santa Clara, CA; or remoteOnsite or Remote Role-Schedule: 8 to 5 in respective time zone; if not in PST time zone, occasional meetings after 5 pm might be required.Top 3 Skills or Any Specific type of Experience you are looking for:* Experience writing Medical Device MDR compliant CERs, CEPs and SSCPs*Microsoft Office proficiency*Vascular or other medical device experience such as Clinical StudyManagement*Education: A bachelor's degree is required along with 6-8 years ofexperience. Excellent analytical abilities with strong organizational and time management skillsRole Overview:We are currently seeking a Clinical Evaluation Reporting (CER) / Medical Writer specializing in vascular medical devices. This role is part of the Regulatory Clinical Evaluation team and involves providing both technical and strategic writing support throughout the product development lifecycle.The primary responsibility is the development of Clinical Evaluation Reports and related documentation for vascular products. The ideal candidate will have experience in clinical study design and management, scientific or medical writing, and/or quality engineering or risk management, along with strong communication skills.Key Responsibilities:Author and contribute to Clinical Evaluation documentation, including Plans/Reports (CER/CEP), PMS and PMCF Plans/Reports, SSCPs, and regulatory responsesReview, evaluate, and summarize clinical data from sources such as clinical trials, published literature, post-market surveillance, and risk assessmentsAnalyze data to support regulatory submissions and product approvalsCollaborate with internal teams and stakeholders to plan and execute CER-related projectsSupport additional deliverables across clinical, regulatory, quality, and engineering functions as neededWork closely with cross-functional teams including Sales & Marketing, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, Risk Management, and Medical AffairsMaintain in-depth knowledge of assigned products and identify relevant data sources for evaluationReview and ensure alignment across documents such as IFUs, patient guides, risk management files, and training materialsContribute to responses for regulatory queries and notified body questionsPrepare documentation for regulatory submissions, risk assessments, and compliance processesEnsure high-quality, accurate, and consistent documentation aligned with internal standards and regulatory requirementsMaintain compliance with applicable regulations and standards such as ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, and FDA/EU guidelinesEducation and Experience:Required:Bachelor's degree or equivalent practical experience6–8 years of medical writing experience in healthcare/pharmaceutical industries or 8+ years in technical writingExperience across medical, pharmaceutical, medical device, or clinical research domainsPreferred:Degree in biomedical sciences, medicine, or a related fieldCER writing experienceStrong communication and interpersonal skillsExperience working in cross-functional teamsStrong analytical and multitasking capabilities with effective time managementProficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook