CLINEXEL Recruitment 2026: Regulatory Medical Writer & Senior CRA Jobs in Navi Mumbai | Apply via Email

by

The clinical research industry in India continues to witness remarkable growth, creating exciting opportunities for professionals with expertise in regulatory documentation and clinical trial management. If you’re looking to take the next step in your clinical research career, CLINEXEL has announced fresh recruitment for experienced professionals in Navi Mumbai, Maharashtra.

The company is currently hiring for Regulatory Medical Writer and Senior Clinical Research Associate (Sr. CRA) positions. These roles offer the opportunity to work with global clinical development projects, international regulatory standards, and experienced professionals in a collaborative work environment.

Whether your expertise lies in medical writing or clinical operations, this recruitment drive offers an excellent opportunity to advance your career in a reputed Contract Research Organization (CRO).

🏢 About CLINEXEL

CLINEXEL is a full-service Contract Research Organization (CRO) that provides comprehensive clinical development solutions to pharmaceutical, biotechnology, and medical device companies across India and international markets.

The organization specializes in clinical trial management, regulatory support, medical writing, pharmacovigilance, and data management while maintaining high standards of quality and compliance. Employees gain exposure to global clinical research projects and internationally accepted regulatory practices.

📌 Available Positions

1️⃣ Regulatory Medical Writer

📍 Location: Navi Mumbai, Maharashtra

💼 Work Mode: Office-Based

Key Responsibilities

  • Draft and prepare Clinical Study Reports (CSRs)
  • Develop Investigator Brochures (IBs)
  • Prepare Clinical Trial Protocols and Protocol Amendments
  • Create regulatory submission documents
  • Interpret scientific and statistical data accurately
  • Conduct literature reviews
  • Ensure document consistency and scientific accuracy
  • Maintain compliance with ICH-GCP, FDA, and EMA guidelines
  • Coordinate with clinicians, statisticians, and project teams

Desired Skills

  • Excellent scientific writing abilities
  • Strong medical terminology knowledge
  • Experience with regulatory documentation
  • Good analytical and communication skills
  • High attention to detail
  • Ability to work within strict timelines

2️⃣ Senior Clinical Research Associate (Senior CRA)

📍 Location: Navi Mumbai, Maharashtra

💼 Work Mode: Office-Based with Site Coordination

Key Responsibilities

  • Manage assigned clinical trial sites
  • Conduct Site Initiation Visits (SIV)
  • Perform Interim Monitoring Visits (IMV)
  • Execute Close-Out Visits (COV)
  • Perform Source Data Verification (SDV)
  • Ensure protocol compliance
  • Maintain ICH-GCP standards
  • Resolve clinical data queries
  • Coordinate with investigators and site staff
  • Prepare monitoring reports
  • Ensure patient safety throughout study conduct

Desired Skills

  • Strong clinical monitoring experience
  • Excellent understanding of ICH-GCP guidelines
  • Good documentation skills
  • Effective communication and coordination
  • Ability to manage multiple study sites
  • Strong problem-solving abilities

🎯 Why Join CLINEXEL?

✅ Opportunity to work on global clinical trials

✅ Exposure to international regulatory standards

✅ Professional and collaborative work environment

✅ Career growth within a reputed CRO

✅ Work alongside experienced clinical research professionals

✅ Opportunity to strengthen expertise in regulatory affairs and clinical operations

✅ Corporate office located in Navi Mumbai with excellent connectivity

👨‍🎓 Preferred Qualifications

Candidates with qualifications such as:

  • B.Pharm
  • M.Pharm
  • Pharm.D
  • BSc Life Sciences
  • MSc Life Sciences
  • Biotechnology
  • Microbiology
  • Biochemistry
  • Clinical Research
  • Other Life Science disciplines

along with relevant experience in medical writing or clinical monitoring are encouraged to apply.

📍 Job Location

Navi Mumbai, Maharashtra

📧 How to Apply?

Interested candidates can send their updated resume directly to the HR team.

Primary Email IDs

📧 careers@clinexel-cro.com

OR

📧 careers@clinexel.com

📄 Documents Required

  • Updated Resume (PDF preferred)
  • Relevant Experience Details
  • Current CTC
  • Expected CTC
  • Notice Period
  • Contact Information

💡 Email Subject Examples

  • Application for Regulatory Medical Writer – Your Name
  • Application for Senior Clinical Research Associate – Your Name

✅ Tips for a Successful Application

  • Keep your resume updated with recent projects.
  • Highlight therapeutic area experience.
  • Mention ICH-GCP certification if applicable.
  • Include monitoring or medical writing experience.
  • Proofread your resume before sending.
  • Use a professional email subject line.
  • Ensure all contact details are current.

🚀 Why This Opportunity Stands Out

Working with CLINEXEL provides professionals the chance to contribute to high-quality clinical research projects while developing expertise in global regulatory standards. Both positions offer meaningful responsibilities, exposure to international clinical development practices, and opportunities for long-term professional growth in one of the fastest-growing sectors of healthcare.

If you possess the required skills and experience, this recruitment drive could be the perfect opportunity to advance your career in clinical research.

🔗 Related Job Opportunities

Leave a Comment

WhatsApp Telegram