Indero is a Contract Research Organization (CRO) specializing in dermatology and rheumatology clinical trials. Since 2000, we’ve built a strong reputation for high-quality research and exceeding client expectations. With offices in Montreal, North America, and Europe, we continue to expand globally.
At Indero, we value collaboration, innovation, reliability, and responsiveness. Our team thrives in a dynamic, supportive work environment with opportunities for career growth and skill development.
Job Title: Regulatory Documents Assistant (India)
Location: Remote/Office-Based (India)
Employment Type: Permanent, Full-Time
Industry: Clinical Research Organization (CRO) – Regulatory Affairs
Key Responsibilities:
As a Regulatory Documents Assistant, you will ensure the accuracy and compliance of clinical trial documentation. Your role includes:
✔ Trial Master File (TMF) Management – Setting up and maintaining electronic/paper TMFs.
✔ Document Review – Ensuring all essential documents meet ICH-GCP and company SOPs.
✔ eTMF Oversight – Assisting in eTMF setup, metadata tracking, and quality reviews.
✔ Regulatory Compliance – Reviewing site regulatory documents for accuracy.
✔ Collaboration – Working with CRAs, project teams, and sites to resolve TMF issues.
✔ Administrative Support – Assisting in study material shipments and tracking tools.
Eligibility & Requirements:
- Education: College degree (Life Sciences, Pharmacy, or related field preferred).
- Experience:
- Knowledge of clinical trial operations.
- Prior experience in pharma, biotech, or CRO industry (preferred).
- Skills:
- Proficiency in Microsoft Word & Excel.
- Strong organizational skills with attention to detail.
- Ability to multitask and meet deadlines.
- Language: English (Intermediate), French (an asset).
Benefits & Perks:
✅ Flexible work schedule (work-life balance).
✅ Permanent full-time position with job security.
✅ Company benefits package (health, insurance, etc.).
✅ Ongoing learning & development opportunities.
✅ Collaborative & innovative work culture.
How to Apply?
