Job Title: Clinical Operations Specialist with Medical Writing
Location: selaiyur, East Tambaram
Position Overview:
We are seeking a highly motivated and detail-oriented Clinical Operations Specialist with expertise in Medical Writing to join our dynamic team. The successful candidate will play a crucial role in managing clinical research projects and ensuring the accurate and timely documentation of clinical study reports, protocols, and other regulatory documents.
**Key Responsibilities:**
- Oversee and manage clinical research projects from initiation to completion, ensuring compliance with regulatory requirements and company standards.
- Develop, review, and edit clinical study protocols, informed consent forms, clinical study reports, and other essential documents.
- Collaborate with cross-functional teams, including clinical research associates, data managers, and biostatisticians, to ensure the integrity and quality of clinical data.
- Maintain up-to-date knowledge of regulatory guidelines and industry best practices related to clinical research and medical writing.
- Coordinate with external vendors and stakeholders to ensure timely delivery of project milestones.
- Provide training and mentorship to junior staff on clinical operations and medical writing best practices.
- Participate in the preparation and submission of regulatory documents to health authorities.
- Ensure proper documentation and archiving of all clinical study materials.
**Qualifications:**
- Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degree (Master's or Ph.D.) preferred.
- Minimum of 4-10 years of experience in clinical operations and medical writing within the pharmaceutical or CRO industry.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements
About Us:
Micro Therapeutic Research Labs Pvt Ltd (MTR) is a quality-driven, full-service Contract Research Organization (CRO) that provides a broad range of bio research services to global pharmaceutical, biotechnology, nutraceutical, and cosmetic industries. We specialize in bioavailability and bioequivalence testing, offering comprehensive clinical research services to our clients worldwide.
Job Type: Full-time
Pay: ₹35,000.00 - ₹80,000.00 per month
Benefits:
Work Location: In person
