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CMC Dossier Preparation

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:

Job Skills

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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

Candidate Profile:

Job Skills

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Clinical Operations Lead (USA)

posted by: spj_bot

About the Job

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead (USA), you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies in the vibrant U.S. market.

This position offers a unique opportunity to lead a dedicated team while collaborating with various stakeholders to uphold the highest standards of quality in clinical operations. You will be instrumental in driving innovation and contributing to cutting-edge research initiatives that shape the future of healthcare.

Main Responsibilities

Job Skills

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Clinical Project 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.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. 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

  • Coordinate the local clinical team involved in national and international oncology trials.
  • Participate in the development of study documents (protocols, ICFs, CRFs, etc.).
  • Manage the study budget and timeline to ensure efficient execution.
  • Oversee site and vendor selection, activation, and performance throughout the study.
  • Ensure successful patient recruitment through coordinated clinical activities.
  • Deliver study results with high quality, on time and within budget.
  • Manage regulatory submissions and administrative follow-up in compliance with ICH-GCP and local regulations.
  • Lead feasibility assessments and investigator selection.
  • Provide transversal management and operational oversight of CRAs.

Requirements

Job Skills

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Regulatory Affairs Officer

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 within Regulatory Affairs. You will play a key part in ensuring compliance, supporting regulatory strategies, and enabling the successful development and maintenance of innovative health products. You’ll evolve in a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

Job Skills

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Clinical Operations Lead

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 Clinical Operations. 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

Job Skills

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Manager - Market Access (Pharma & Life sciences)

posted by: spj_bot

Tiger Analytics is an advanced analytics consulting firm. We are the trusted analytics partner for several Fortune 100 companies, enabling them to generate business value from data. Our consultants bring deep expertise in Data Science, Machine Learning, and AI. Various market research firms, including Forrester and Gartner, have recognized our business value and leadership. We solve complex analytical problems at scale and have built a reputation for delivering valuable data-driven solutions across various industries, including Pharma and Life Sciences.

We are seeking an experienced Business Analyst & Team Lead with strong domain expertise in Life Sciences and Pharma, particularly in Market Access and Speciality Pharma. The ideal candidate will combine deep domain knowledge with strong analytics and leadership skills to deliver high-quality, client-facing solutions

Job Skills

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(Senior) Talent Acquisition Partner

posted by: spj_bot

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 Talent Acquisition. 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.

As a Talent Acquisition Partner, you’ll join a collaborative and forward-thinking team that plays a pivotal role in shaping Excelya’s growth across the globe. Working closely with hiring managers and operational teams, you’ll lead high-volume and fast-paced recruitment efforts for critical roles in clinical research. This is a unique opportunity to bring your expertise to a fast-paced, mission-driven environment where your ideas are valued, your development is supported, and your work directly contributes to advancing healthcare innovation.

Main Responsibilities

Job Skills

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(Senior) Talent Acquisition Partner BeNe

posted by: spj_bot

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 Talent Acquisition. 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.

As a Talent Acquisition Partner, you’ll join a collaborative and forward-thinking team that plays a pivotal role in shaping Excelya’s growth across the globe. Working closely with hiring managers and operational teams, you’ll lead high-volume and fast-paced recruitment efforts for critical roles in clinical research. This is a unique opportunity to bring your expertise to a fast-paced, mission-driven environment where your ideas are valued, your development is supported, and your work directly contributes to advancing healthcare innovation.

Main Responsibilities

Job Skills

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Senior Quality Assurance & Vendor 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. This role is an exciting managerial opportunity to contribute to Excelya’s Quality Assurance team.

In this hands-on and highly autonomous operational position, you will lead your team while actively shaping the organization’s quality culture. You will collaborate across functions and oversee critical QA processes, including vendor management, audits, CAPAs, and continuous improvement initiatives. This position offers a dynamic career path within a stimulating and expanding QA environment.

Key Responsibilities

In this role you are expected to:

Job Skills

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