Remote Clinical Regulatory Writer II: CSR & Protocols

Cardinal Health; Ennis Municipal District; Remoto; EUR 55.000 - 90.000; Tempo pieno

Descrizione del lavoro

Cardinal Health Regulatory Sciences Ireland is expanding its first medical writing team. This permanent role offers long-term growth potential and remote work flexibility for a life science professional.

Your responsibilities include authoring and reviewing Clinical Study Reports and protocols, managing timelines, and collaborating with cross-functional teams to deliver high-quality regulatory documents on schedule.

Competenze

• 2–3 years of clinical regulatory writing experience in pharma/biotech/CRO.
• Experience authoring and reviewing Regulatory documents and CSRs.
• Experience with protocols and clinical study documents.
• Ability to understand clinical trial data, methodologies and complex research.
• Excellent writing, editing and proofreading skills.
• Ability to work independently and in a team.
• Ability to work under pressure and meet deadlines.
• English proficiency required.
• Proficiency with document management tools (Veeva, MS Office).

Mansioni

• Author, review and edit regulatory documents with a focus on CSRs and protocols, ensuring regulatory compliance and client expectations.
• Ensure documents meet regulatory requirements, quality standards and timelines.
• Incorporate reviewer feedback and manage version control across stakeholders.
• Document timelines and ensure on-time, on-budget project delivery.

Conoscenze

Regulatory writing

CSR writing

Protocols writing

Independent work

Team collaboration

Editing/writing quality

English proficiency

Formazione

Bachelor's or Master's degree in life science

Strumenti

Veeva

MS Office

Descrizione del lavoro

Cardinal Health Regulatory Sciences Ireland is expanding its first medical writing team. This permanent role offers long-term growth potential and remote work flexibility for a life science professional.

Your responsibilities include authoring and reviewing Clinical Study Reports and protocols, managing timelines, and collaborating with cross-functional teams to deliver high-quality regulatory documents on schedule.