Job Summary: Responsible for providing substantive contributions and support to the CTI Regulatory and Scientific Affairs group in all phases of regulatory development and medical writing projects in accordance with any applicable CTI Standard Operating Procedures (SOPs).What You'll DoCollaborate with project teams and assist with a broad spectrum of Regulatory and Scientific Affairs projects:Research: review and develop background information for assigned projectsWriting: with some direct supervision , write and edit scientific documents such as protocols, clinical study reports, investigator brochures, and designation requestsQuality: assist in establishing processes to ensure the quality of medical writing deliverablesProblem Solving: create of effective solutions to challenges that arise during projectsImplementation: assist in the production and finalization of quality deliverables on time and on budgetWorking knowledge of regional requirements and processesProvide project status reports to management/project leadsInteract with clients to understand their objectives and meet their needs.Assist in presenting information at internal or external meetingsInteract and collaborate effectively with multidisciplinary departmentsRely on instructions and pre-established guidelines to perform functions of the job under supervision but able to work independently with some directionAssist in the development and delivery of educational materials for staffDevelop and maintain knowledge and expertise across multiple therapeutic areas through ongoing awareness of updates to industry practices, and participation in professional activitiesWhat You'll BringAdvanced degree in allied health science fields such as nursing, pharmacy or natural science or equivalent work experienceAt least 10 years of relevant scientific or regulatory writing experienceExperience in preparation of technically complex documents intended for submission to regulatory authoritiesDirect experience working in the pharmaceutical industry (e.g., contract research organization, pharmaceutical, biotechnology, or medical device company)Experience in writing sections for NDA, BLA. CTA, MAA, 510k, PMAGlobal experience is highly desiredWhy CTI?We support career progression - 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forwardWe value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training departmentWe value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decadeOur culture is unparalleled - Click here to learn more about "The CTI Way"We think globally and act locally - We have a global philanthropic program supporting our team's efforts to improve their local communities (Click here to learn more about our "CTI Cares" program)Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( or from our verified LinkedIn page. Please NoteWe will never communicate with you via Microsoft Teams or text messageWe will never ask for your bank account information at any point during the recruitment process
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