We are inviting two Subject Matter Experts with 5 to 10 years of experience in regulatory and medical writing, specifically with expertise in investigational applications for both drugs/biologics and medical devices, to volunteer for an important role in updating our "Intermediate Medical Writing: Investigational Applications" course.
Last updated in 2017, this course is designed to provide a comprehensive overview of the variety of investigational applications and aims to equip participants with the knowledge and skills to produce high-quality regulatory documents. The evolving nature of regulatory requirements necessitates an update to ensure the course content remains relevant and current.
Course Overview:
This course offers in-depth insights into:
- Key investigational submissions for drugs/biologics, including the Investigational New Drug Application (IND), Canadian Clinical Trial Application (CTA), and Investigational Medicinal Product Dossier (IMPD).
- Investigational applications for medical devices, such as the Investigational Device Exemption (IDE), European CTA, and Investigational Testing Authorization (ITA).
- The components of each application type and strategies to enhance document quality.
- Techniques for improving document quality to advance careers in regulatory and medical writing.
Volunteer Role Expectations:
The SMEs will:
- Review the current course material to determine its accuracy and relevance in today's regulatory environment.
- Identify areas in need of updates or overhaul to incorporate the latest regulatory changes and writing best practices.
- Update the course to cover new developments in investigational applications for drugs/biologics and medical devices.
- Ensure the course provides practical insights and actionable guidance for regulatory and medical writers aiming to improve document quality and efficacy.
Volunteer Specifications:
- Individuals with 5 to 10 years of professional experience in regulatory and medical writing, particularly with a focus on investigational applications.
- Comprehensive knowledge of investigational submissions for drugs/biologics and medical devices, including regional variations and requirements.
- Expertise in document quality improvement techniques and best practices in medical writing.
- Strong research, analytical, and content development skills.
- A commitment to contributing to the professional development of others in the field of regulatory and medical writing.
Key Details:
- Number of Volunteers Needed: Two
- Incentive: Recognition for contributions and a certificate of appreciation.
This volunteer opportunity offers a unique chance to significantly influence the development of regulatory and medical writing professionals, ensuring they have access to the most current and comprehensive information on investigational applications. By sharing your expertise, you will help ensure that the course remains an invaluable resource for those looking to advance in this critical area of the pharmaceutical and medical device industries.
Interested candidates are encouraged to apply by submitting their resume and a brief statement of interest, focusing on their experience with investigational applications and any prior contributions to educational content or regulatory projects.
Join us in this essential project to update and enhance the "Intermediate Medical Writing: Investigational Applications" course, ensuring it reflects the latest in regulatory requirements and best practices since its last update in 2017. We look forward to your expertise and enthusiasm for this initiative!
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