job description
Are you a skilled Regulatory Writer with expertise in eCOA (Electronic Clinical Outcome Assessments)? Join One CoreDev IT in beautiful Bali and play a pivotal role in shaping high-quality regulatory content for the healthcare and medical industry. This is a unique opportunity to combine your writing prowess with technical knowledge in a dynamic, remote-friendly environment.
As a Content Manager with eCOA experience, you will collaborate with cross-functional teams to develop, review, and finalize regulatory documents that meet global compliance standards. Your work will directly impact clinical trials, patient-reported outcomes, and digital health solutions. If you thrive in a detail-oriented, fast-paced setting and have a passion for healthcare innovation, we’d love to hear from you!
Why Bali? Enjoy a work-life balance in one of the world’s most inspiring locations, with the flexibility of remote or hybrid work arrangements. One CoreDev IT offers competitive compensation, professional growth opportunities, and a supportive team culture.
Responsibility
- Develop, write, and edit regulatory documents, including clinical study reports, protocols, and patient-reported outcome (PRO) measures, with a focus on eCOA integration.
- Ensure all content adheres to ICH-GCP, FDA, EMA, and other global regulatory guidelines.
- Collaborate with clinical teams, data managers, and IT specialists to align eCOA content with study objectives and digital platforms.
- Manage the review and approval process for regulatory submissions, ensuring accuracy, clarity, and compliance.
- Stay updated on industry trends, eCOA technologies, and regulatory changes to continuously improve content strategies.
- Train and mentor junior writers or team members on regulatory writing best practices and eCOA standards.
- Coordinate with vendors and external partners to integrate eCOA solutions into clinical trial documentation.
- Maintain organized documentation systems and version control for all regulatory content.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Medical Writing, or a related field; advanced degree preferred.
- Minimum 3+ years of experience in regulatory writing, with specific expertise in eCOA/ePRO (Electronic Patient-Reported Outcomes).
- Proven track record of authoring clinical trial documents, protocols, or submission dossiers for regulatory agencies.
- Familiarity with CDISC standards, EDC systems, and eCOA platforms (e.g., Medidata Rave, ClinCapture, or similar).
- Strong understanding of GCP, FDA 21 CFR Part 11, and EU Annex 11 compliance requirements.
- Excellent written and verbal communication skills, with meticulous attention to detail.
- Ability to work independently in a remote setting while collaborating effectively with global teams.
- Certification in regulatory affairs or medical writing (e.g., RAC, AMWA) is a plus.