Medical Writer I (Junior Project Specialist) – 1 Year Contract
Location: Gurugram, India
Work Mode: Hybrid
Employment Type: 1-Year Contract
Department: Medical Writing / Regulatory Operations
Job Overview
We are seeking a detail-oriented Medical Writer I (Junior Project Specialist) to support document management, regulatory filing, and quality-controlled content handling activities within a clinical and regulatory environment. This role involves working with electronic document management systems, maintaining compliance with regulatory requirements, and ensuring the integrity, organization, and accessibility of critical project documentation.
The ideal candidate should possess strong organizational skills, a solid understanding of GxP guidelines, and the ability to manage document workflows efficiently while collaborating with cross-functional teams and client stakeholders.
Key Responsibilities
Document Management and Regulatory Filing
Support accurate and compliant document filing activities within Veeva RIM and related systems.
Perform eTMF filing activities while ensuring adherence to established filing procedures and regulatory requirements.
Manage document downloads from internal systems and upload records into Veeva with appropriate classification and storage.
Ensure all project documents meet quality, integrity, and compliance standards before filing.
Maintain accurate documentation records and support efficient document retrieval processes.
Metadata and Quality Control
Verify document metadata accuracy before filing.
Apply correct naming conventions and document classification standards.
Ensure documents are stored in appropriate locations within the electronic document management system.
Conduct quality checks to maintain document consistency and compliance.
Project Documentation Support
Track project documents and maintain up-to-date project records.
Support document lifecycle management activities.
Ensure timely completion of filing activities and project milestones.
Maintain organized repositories for efficient document access and management.
Regulatory Compliance
Follow GxP guidelines and industry best practices for document handling and record management.
Maintain awareness of FDA, EU, and other applicable regulatory requirements.
Ensure all documentation complies with sponsor expectations and regulatory standards.
Support audit readiness through proper documentation and filing practices.
Digital Archiving and Record Management
Support digital archiving activities and electronic record preservation.
Ensure secure, systematic, and long-term storage of electronic documents.
Maintain data integrity and document traceability throughout the record lifecycle.
Process Improvement and Collaboration
Contribute to the development and refinement of workflows, procedures, and Standard Operating Procedures (SOPs).
Adapt to evolving operational requirements and business processes.
Collaborate with internal teams and client stakeholders to support project objectives.
Participate in internal and client-facing meetings as required.
Scope of Work
The filing scope may include:
Early Access Programs
Individual Patient Requests
External Research Projects
Observational Studies
Non-Interventional Studies
Medical and Regulatory Documentation
Required Qualifications
Education
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Medical Sciences, or a related field.
Master's degree candidates may also apply.
Technical Knowledge
Basic understanding of clinical research documentation and regulatory processes.
Knowledge of GxP guidelines and compliance requirements.
Familiarity with electronic document management systems such as Veeva RIM or eTMF platforms is preferred.
Understanding of regulatory document handling and quality control processes.
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