Document Life Cycle Management

2 weeks ago

Hyderabad, India Ritsa Full time

Company Overview

Ritsa Pharma is a global pharmaceutical contract development and manufacturing organization headquartered in Hyderabad. We specialize in the commercialization of drug products, ensuring they meet the highest quality standards and regulatory requirements. Our operations integrate scientific principles and process controls to deliver cost-effective and timely solutions. With a team of 51-200 employees, Ritsa Pharma is a key player in the Pharmaceutical Manufacturing industry. Visit our website at ritsapharma.com for more information.


Job Overview

We are seeking a qualified Document Life Cycle Management professional with a minimum of 4 to 6 years of work experience. This is a full-time, mid-level position based in our Hyderabad office. The selected candidate will play a crucial role in ensuring efficient management of documents throughout their lifecycle in compliance with regulatory standards.


Qualifications and Skills

  • Experience in regulatory compliance is mandatory for ensuring all documents adhere to needed standards.
  • Proficiency in clinical trial management is mandatory to oversee and document clinical trial processes efficiently.
  • Expertise in project management software is mandatory for organizing, controlling, and executing project documentation.
  • Proven ability to utilize pharmacovigilance systems to monitor, assess, and prevent adverse effects.
  • Understanding of market access strategy to facilitate successful document management for product distribution.
  • Knowledge of biostatistics to accurately manage and interpret data-related documents.
  • Competence in supply chain optimization for effective documentation in managing supply logistics.
  • Familiarity with health economics to document the economic evaluation of healthcare services.


Roles and Responsibilities

  • Manage the full lifecycle of documents from creation to disposal while ensuring compliance with regulatory requirements.
  • Coordinate with cross-functional teams to ensure the accuracy and completeness of document content.
  • Implement and maintain effective document version control processes.
  • Ensure timely access to documents for stakeholders to support business operations and decision-making.
  • Maintain a document management system that supports efficient storage, retrieval, and sharing of documents.
  • Collaborate with the project management and clinical trial teams to support documentation related to trial management.
  • Prepare and present reports on document status, ensuring management is informed of any risks or issues.
  • Stay updated with industry regulations and best practices to continuously improve document management procedures.

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