Freshers Pharm D Documentation Specialist Clinical Research at Forward Life, Apply on Rasayanika

Location: Hyderabad

Company Name: Forward Life

Department: Regulatory Affairs / Quality Assurance / Ethics Committees

Reporting To: Head of Department

Employment Type: Full-Time

Gender Preference: Male

Experience Level: 2–3 years

Salary: ₹18,883.04 – ₹21,319.24 per month

Organization Overview

We are a leading Clinical Research Organization (CRO) committed to excellence in clinical trials, regulatory affairs, and quality compliance. Our mission is to deliver quality-driven research support while adhering to global standards including GCP, ICH, and national regulatory requirements.

Job Summary

The Documentation Specialist plays a critical role in managing and organizing regulatory, clinical, and operational documents in compliance with applicable regulatory guidelines, SOPs, and license conditions. The role supports audit readiness, inspection preparedness, and ensures timely, accurate documentation to facilitate smooth CRO operations.

Key Responsibilities

• Create, format, and maintain controlled documents such as SOPs, study protocols, reports, and investigator manuals.
• Ensure document version control and secure archival practices.
• Coordinate with cross-functional teams for document approvals and updates.
• Manage document workflows using Electronic Document Management Systems (EDMS).
• Assist in compiling regulatory submissions (e.g., for CDSCO, DCGI, USFDA, EMA) and maintain submission records.
• Maintain and organize master files for clinical studies and Ethics Committees (EC/IRB).
• Support internal and external audits with accurate, on-time document retrieval.
• Monitor SOP revision cycles and update associated training records.
• Uphold strict confidentiality and data integrity across documentation systems.

Qualifications

Educational Requirement: Pharm.D or Postgraduate with Clinical Research Certification.

Experience:

• 2–3 years in a documentation role (CRO, pharmaceutical, or healthcare domain preferred).
• Freshers with strong coordination skills may also apply.

Preferred Skills

• Familiarity with GCP, ICH guidelines, and regulatory standards.
• Working knowledge of EDMS platforms (e.g., MasterControl, Veeva Vault).
• Experience handling submissions through SUGAM Portal, SAE reporting.
• Competence in coordinating Ethics Committee documentation and regulatory submissions.
• Experience managing varied clinical research proposals and client interactions.
• Strong organizational and communication skills.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Ability to multitask, prioritize, and meet deadlines consistently.
• Skilled in conducting meetings, client communication, and maintaining detailed records.