Senior Redaction and Public Disclosure Specialist

0 years

0 Lacs

Posted:1 week ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

About the Job

Audacity, Care, and Energy

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Writing department. 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

  • Perform redaction and anonymisation of clinical documents (CSRs, Protocols, IBs) and ensure consistency, quality, and auditability.
  • Prepare, format, and submit documents for public disclosure portals (EMA, Health Canada).
  • Coordinate timelines and deliverables across multiple projects; ensure on-time completion.
  • Collaborate with cross-functional teams (Medical Writing, QA, Regulatory, Biostats, Data Management, Clinical) and interact with clients as needed.
  • Train, mentor, and provide backup support to RPDS team members; review and approve their redaction work.
  • Support project management, sponsor communication, and contribute to SOPs, processes, and financial offer preparation.

Requirements

About You

At Excelya, we value curiosity, rigor, and a collaborative mindset. We're looking for someone who is ready to grow with us and contribute to high-quality disclosure and redaction activities.

Experience: Experience in redaction, disclosure, or regulatory roles. For senior profiles, the ability to lead, mentor, and manage complex disclosure activities is essential

Skills: Strong understanding of EMA Policy 0070, Health Canada PRCI, and GDPR, Excellent attention to detail and strong analytical thinking, Comfortable working in fast-paced, collaborative environments, Familiarity with anonymisation tools and techniques Strong organizational and communication abilities, Leadership and mentoring capabilities for senior roles, Advanced proficiency in English

Education: University degree in life sciences or a related field

Languages: Professional English is mandatory, both written and verbal

Benefits

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique

leading mid-size CRO

Excelling with care


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