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Sr Data Architect - Patient Services (Life Sciences)

posted by: spj_bot

Tiger Analytics is pioneering what AI and analytics can do to solve some of the toughest problems faced by organizations globally. We develop bespoke solutions powered by data and technology for several Fortune 100 companies. We have offices in multiple cities across the US, UK, India, and Singapore, and a substantial remote global workforce.

We are seeking a Data Architect – Patient Services to join our Life Sciences practice. In this role, you will be responsible for ensuring the integrity and reliability of Patient Services (PS) data and be the primary bridge between external Patient Services Hub vendors and internal enterprise systems. This is a high-impact role combining technical data modeling with operational stewardship, requiring you to drive data quality, investigate complex lineage issues, and ensure that patient data is "analytics-ready" for strategic decision-making.

Responsibilities:

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Senior CMC Regulatory Technical Writer

posted by: spj_bot

About the Job

Join Excelya as a Senior CMC Regulatory Technical Writer, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements.

This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding.

Main Responsibilities:

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Quality Document Manager

posted by: spj_bot

About the Job

At Excelya, we uphold the values of Audacity, Care, and Energy in everything we do. We are seeking a dedicated Quality Document Manager to join our Quality Assurance team.

As part of the R&D Quality Assurance team, you will support the Quality Management System (QMS) dedicated to Research and Translational Medicine activities within Preclinical Data Management.

You will contribute to maintaining and improving the quality documentation framework, ensuring compliance with internal policies and applicable regulations. This role offers strong exposure to cross-functional R&D teams in a structured and scientifically driven environment.

Main Responsibilities

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Data Quality Management Consultant

posted by: spj_bot

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

The Data Quality Management role is essential in ensuring that our data meets the highest standards for quality and integrity throughout the research and pharmaceutical development process.

Main Activities:

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Project Management Officer - Digital & AI Transformation (R&D)

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data & AI. You will play a critical part in driving innovation and making an impact in the clinical research space while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

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International Regulatory Affairs Officer - Advertising & Promotion

posted by: spj_bot

About the Job

Excelya is seeking an experienced International Regulatory Affairs Officer specializing in Advertising and Promotion. In this pivotal role, you will be part of a dedicated team that embodies Audacity, Care, and Energy, contributing to our mission of ensuring compliance and excellence in promotional practices across global markets.

Your expertise will drive the development and implementation of regulatory strategies for advertising and promotional materials, ensuring adherence to regulations across various international jurisdictions while aligning with our corporate goals.

Main Responsibilities:

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Medical Affairs Lead - Medical Devices

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As the Head of Medical Affairs, you will lead our efforts in shaping the medical strategy and direction for our product portfolio, ensuring that our initiatives align with our mission of advancing patient care through innovative solutions.

This position offers an exceptional opportunity to work at the intersection of science and business, leading a dedicated team while collaborating cross-functionally to achieve our goals.

Main Responsibilities

Medical & Scientific Leadership

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Biosample manager

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The Biosample Manager is crucial in coordinating and overseeing the management of biological samples throughout clinical studies, ensuring compliance with regulatory guidelines and study protocols.

Main Responsibilities:

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CMC Dossier Preparation Specialist

posted by: spj_bot

About the Position

Excelya is seeking a CMC Dossier Preparation Specialist to join our dynamic team. In this role, you will be responsible for the preparation and management of Chemistry, Manufacturing, and Controls (CMC) documents for regulatory submissions. Your contributions will play a crucial role in ensuring compliance with regulatory requirements and supporting the development and lifecycle management of pharmaceutical products.

Your expertise will not only facilitate the timely submission of high-quality CMC documentation but will also help ensure that our products adhere to the highest standards of quality and regulatory compliance.

Main Responsibilities:

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CMC Specialist

posted by: spj_bot

About the Job

Join Excelya as a CMC Specialist and become an integral part of a dedicated team that values Audacity, Care, and Energy. In this role, you will contribute to the CMC regulatory strategy and support the development, manufacturing, and lifecycle management of pharmaceutical products.

Your expertise will help to ensure compliance with regulatory requirements while facilitating the delivery of innovative therapies to patients. You will be part of a stimulating professional environment where personal and intellectual growth is encouraged.

Main Responsibilities:

  • Support the preparation, review, and submission of regulatory documentation related to Chemistry, Manufacturing, and Controls (CMC) for drug development and marketed products.
  • Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing to develop and implement CMC strategies.
  • Assess regulatory impact of changes in manufacturing processes and provide recommendations for compliance.
  • Assist in responding to regulatory inquiries and follow up with health agencies on CMC matters.
  • Monitor industry trends and regulatory updates to ensure compliance with evolving guidelines.
  • Support continuous improvement initiatives within the CMC function.

Requirements

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