USA - Medical Writer II

Description We are offering an opportunity to join our team as a Technical Writer in the healthcare industry. This remote role is based out of Milwaukee, Wisconsin and involves developing high-quality clinical documents to support regulatory submissions for our products. The role requires an understanding of global regulatory authority regulations and the ability to interpret and summarize clinical and non-clinical data. Responsibilities: Develop high-quality clinical documents ensuring scientific excellence and regulatory compliance Interpret and summarize clinical and non-clinical data, compiling information and ensuring delivery within timelines Prepare clinical documents such as investigator brochures, protocols, clinical study reports, integrated reports, clinical sections of core technical documents, and manuscripts/abstracts for publication Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and apply procedures as applicable Work closely with cross-functional team members and serve as a representative at study team meetings Prepare document timelines with guidance from manager as needed Conduct literature searches Develop deeper knowledge of specific therapeutic areas Analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner Manage multiple projects with competing priorities Proficient in Microsoft Office Suite including Word, Excel, PowerPoint, OneNote, Outlook, and Teams. Requirements Demonstrated proficiency in Office Functions Excellent skills in Documentation Proficiency in Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft PowerPoint Familiarity with Procedures Ability to maintain Quality in work Experience in creating Presentations Knowledge of Workstation Support Understanding of Medical Coverage Proficiency in English Language Familiarity with Regulations Experience in Clinical Trial Operations Knowledge of Protocols Ability to Ensure Compliance Experience with Oversight Familiarity with Submission process Knowledge in Statistics Experience in creating Briefings Ability to manage Timelines Experience in creating Summary Reports Familiarity with Brochures Experience with Templates Familiarity with conducting Trials Innovation starts with people.® Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more.All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.© 2024 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https:///www.roberthalf.com/us/en/terms) .