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
• 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