Medical Writer II | Maple Grove, MN Medical Writer II Maple Grove, MN Humera is currently hiring a Medical Device Writer II, for our client based in Maple Grove, MN The Sr. Medical Writer on the Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to authoring clinical evaluation reporting documents for the Neuromodulation, CAHF and Vascular products. Experience in clinical study management and design, medical, or scientific writing, quality engineering, risk management is needed. Duties and Responsibilities + Writes and contributes to clinical evaluation reporting deliverables including clinical evaluation plan, PMS and PMCF plans, SSCPs, regulatory responses and other items + Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, and post-market surveillance + Collaborates with team members and stakeholders in planning for and supporting CER related projects + Supports additional clinical, regulatory, quality, and engineering related deliverables + Effectively communicate and collaborate with various departments + Maintains thorough knowledge of assigned products, and identifies appropriate sources of relevant data + Reviews IFUs, patient guides, risk management files, clinical evaluation reports, physical training materials, ensuring alignment of information + Responsible for compliance with applicable regulations and guidance (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1) Education and Experience Required + Bachelor's Degree or an equivalent combination of education and work experience + 4-6 years of medical writing experience in medical or pharmaceutical industry or 7+ years of technical writing experience + Experience may include writing in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination Preferred + Biomedical, sciences, medicine or similar health related disciplines + CER writing experience + Experience with collaborative, cross functional teams + Excellent analytical skills and ability to manage complex tasks and time effectively Post Date: 01.28.2025 Salary: $38.00 /hr Shift: 1st Benefits: Health care insurance benefits available first of the month following 60 days of employment. Thirty (30) hours worked per week must be averaged in order to maintain coverage. 401k enrollment is available per the Secure Act guidelines. Earned Sick and Safe time is accrued and can be used per the State of MN guidelines. Interested in this Job? You're on your way to a new career! If you would like to see more jobs Click Here Please Login, Register or you can Quick Apply Quick Apply Sign In First Name: * Last Name: * Please enter at least phone or email. Phone Number: Email Address: Tell us what your career objective is: * Are you 18 years of age or older? * Yes No Do you have reliable transportation to get to and from work each day? Yes No Select your resume to upload (acceptible files are .txt, .rtf, .pdf, .doc and .docx) * Your previously uploaded resume will be used. If you want to use a new resume click here By applying you are consenting to receive phone, email and/or SMS messaging from Humera. For further information, please consult the Privacy Policy. Apply Now Cancel Application Errors: If you would prefer to speak directly to a Humera Staffing Consultant, please call us at 612-977-1440 and reference OrderID 819039