Intern, Clinical Regulatory Writing

Job Description: • Participate in the authoring and review of clinical and regulatory documents relating to global marketing applications and clinical trials (eg, clinical study reports, protocols, safety narratives) • Learn and apply medical writing standards • Understand the process of distilling large amounts of clinical and scientific data into essential elements for tabular and graphical display • Perform literature-based research to support writing activities • Begin to understand global and regional regulatory requirements (eg. ICH E3) and how they impact clinical and regulatory writing • Liaise with clinical trial transparency colleagues to understand how data from clinical and regulatory documents is disclosed publicly Requirements: • Pursuing a Master's degree or PhD. in a scientific or medical field with minimum of first year completed • Understanding of basic biology, clinical research, and medical terminology • Enrolled as a full-time student • Able to work 40 hours/week during normal business hours • Proficient with Microsoft Office Suite • Knowledgeable regarding the use of AI tools • Detail orientated, strong organizational skills • Flexible; adapts work style to meet organizational needs • Good verbal and written communication skills; ability to write clearly and effectively • Capable of completing assigned responsibilities within timelines and providing their manager with project status updates Benefits: • Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans Apply Now Apply Now