Document Specialist I Position at PAREXEL- Apply before  30th March 2025

Join PAREXEL – A Global Leader in Biopharmaceutical Services

Location: Mumbai, India
Job ID: R0000031065
Category: Medical Writing
Application Deadline: 30th March 2025

About PAREXEL

PAREXEL is a trusted partner in the biopharmaceutical industry, supporting global drug development and medical advancements. As a leading provider of contract research, medical communications, and consulting services, we contribute to the success of pharmaceutical, biotechnology, and medical device companies worldwide.

Position Overview

We are looking for a Document Specialist I to support clinical document compilation, publishing, and quality control. The role requires expertise in regulatory submission formats, document publishing software, and project coordination.

Key Responsibilities

1. Compilation & Publishing

• Compile appendices for clinical study reports, ensuring compliance with regulatory requirements.
• Collaborate with internal teams and project leads to ensure completeness and accuracy.
• Utilize publishing software to create electronic deliverables with appropriate navigability and hyperlinks.
• Format clinical documents in MS Word, incorporating tables and regulatory-compliant styles.
• Manage the production and distribution of draft and final documents.

2. Quality Control

• Review all deliverables to ensure they meet regulatory and company standards.
• Verify submission readiness and adherence to industry guidelines.
• Conduct internal reviews of documents before distribution.

3. Document Project Management

• Serve as the primary contact for document compilation and publishing projects.
• Coordinate deliverable timelines and resolve project-related issues.
• Attend project meetings to ensure alignment with client expectations and regulatory requirements.
• Oversee document distribution and maintain proper filing of project documentation.

4. Training & Compliance

• Participate in corporate, project-specific, and departmental training sessions.
• Assist in mentoring new team members as required.

5. General Administrative Support

• Maintain project assignment and workload tracking systems.
• Provide administrative support as needed.

Qualifications & Skills

• Experience in document management, regulatory publishing, or medical writing support.
• Proficiency in MS Word formatting, electronic document publishing, and hyperlinking.
• Strong understanding of global regulatory submission guidelines.
• Excellent attention to detail and ability to manage multiple projects.
• Effective communication and teamwork skills.

Why Join PAREXEL?

• Work with a globally recognized leader in biopharmaceutical services.
• Contribute to impactful drug development projects.
• Gain valuable experience in medical writing and regulatory submissions.
• Collaborate with a dynamic team in a supportive environment.

Apply Now!

Be a part of groundbreaking advancements in healthcare. Submit your application before 30th March 2025 to join our team in Mumbai, India.