Job Title: Clinical Operations Specialist with Medical Writing

Location: MTR, 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.
- Venue: Micro Therapeutic Research Labs Pvt. Ltd (MTRL).

6, Kamarajar Salai, East Tambaram, Selaiyur, Chennai, Tamil Nadu 600059

Share resume - HR - (phone hidden) (WhatsAPP) Pay: ₹35,000.00 - ₹95,000.00 per month

Advantages

- Provident Fund

Work Location: In person

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