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Title
Text copied to clipboard!Junior DTX Documentation Specialist
Description
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We are looking for a Junior DTX Documentation Specialist to join our dynamic team. The ideal candidate will be responsible for managing, organizing, and maintaining accurate documentation related to digital therapeutic (DTX) products and services. This role involves collaborating closely with cross-functional teams, including product development, regulatory affairs, quality assurance, and clinical research, to ensure all documentation meets regulatory standards and internal guidelines.
The Junior DTX Documentation Specialist will play a critical role in supporting the documentation lifecycle, from creation and revision to approval and archival. You will be expected to maintain meticulous records, ensuring compliance with industry standards and regulatory requirements. Attention to detail, strong organizational skills, and the ability to manage multiple tasks simultaneously are essential for success in this role.
In this position, you will assist in the preparation and review of technical documents, user manuals, standard operating procedures (SOPs), and regulatory submissions. You will also support the documentation of clinical trials, ensuring accuracy, completeness, and compliance with applicable regulations. Additionally, you will be responsible for maintaining document control systems, tracking document revisions, and ensuring timely distribution of updated materials to relevant stakeholders.
The successful candidate will have excellent communication skills, both written and verbal, and the ability to work effectively in a collaborative environment. You will be proactive in identifying documentation gaps and proposing solutions to improve documentation processes and workflows. Familiarity with digital therapeutic products, regulatory requirements, and quality management systems will be advantageous.
This role offers an excellent opportunity for professional growth and development within the rapidly evolving field of digital therapeutics. You will gain valuable experience working with innovative technologies designed to improve patient outcomes and healthcare delivery. We are committed to providing ongoing training and support to help you succeed and advance your career.
If you are detail-oriented, organized, and passionate about contributing to the advancement of digital healthcare solutions, we encourage you to apply for this exciting opportunity. Join our team and help us make a meaningful impact on patient care through effective documentation management and compliance.
Responsibilities
Text copied to clipboard!- Manage and maintain accurate documentation related to digital therapeutic products.
- Assist in preparing and reviewing technical documents, user manuals, and SOPs.
- Support documentation processes for clinical trials and regulatory submissions.
- Maintain document control systems and track document revisions.
- Collaborate with cross-functional teams to ensure documentation compliance.
- Identify documentation gaps and propose improvements to documentation workflows.
- Ensure timely distribution of updated documentation to relevant stakeholders.
Requirements
Text copied to clipboard!- Bachelor's degree in healthcare, life sciences, or related field.
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
- Ability to manage multiple tasks and prioritize effectively.
- Familiarity with regulatory requirements and quality management systems preferred.
- Proficiency in document management software and Microsoft Office Suite.
- Previous experience in healthcare documentation or clinical research is advantageous.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with document management systems?
- How do you ensure accuracy and compliance in your documentation work?
- Have you previously worked with regulatory submissions or clinical trial documentation?
- What strategies do you use to manage multiple documentation tasks simultaneously?
- Can you provide an example of how you identified and resolved a documentation gap?
