Senior Medical Writer, Regulatory & Scientific Affairs (RSA)

What You'll Do

• Collaborate with project teams and assist with a broad spectrum of Regulatory and Scientific Affairs projects:
  • Research: review and develop background information for assigned projects
  • Writing: with some direct supervision , write and edit scientific documents such as protocols, clinical study reports, investigator brochures, and designation requests
  • Quality: assist in establishing processes to ensure the quality of medical writing deliverables
  • Problem Solving: create of effective solutions to challenges that arise during projects
  • Implementation: assist in the production and finalization of quality deliverables on time and on budget
• Working knowledge of regional requirements and processes
• Provide project status reports to management/project leads
• Interact with clients to understand their objectives and meet their needs.
• Assist in presenting information at internal or external meetings
• Interact and collaborate effectively with multidisciplinary departments
• Rely on instructions and pre-established guidelines to perform functions of the job under supervision but able to work independently with some direction
• Assist in the development and delivery of educational materials for staff
• Develop and maintain knowledge and expertise across multiple therapeutic areas through ongoing awareness of updates to industry practices, and participation in professional activities

What You'll Bring

• Advanced degree in allied health science fields such as nursing, pharmacy or natural science or equivalent work experience
• At least 10 years of relevant scientific or regulatory writing experience
• Experience in preparation of technically complex documents intended for submission to regulatory authorities
• Direct 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, PMA
• Global experience is highly desired

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.