Clinical Regulatory Writing Specialist

Cardinal Health; Ireland; In loco; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Cardinal Health Ireland seeks an experienced regulatory writer to join our first medical writing team in Ireland, supporting client partnerships on clinical study reports, regulatory submissions, and CTD modules. You will collaborate with cross-functional teams and manage timelines.

The role requires a life science degree, 2–3 years in pharmaceutical writing, strong writing/editing skills, and the ability to work independently in a fast-paced environment.

Competenze

• Bachelor's or Master's degree in life sciences (biology, pharmacology, biochemistry) required.
• 2–3 years of clinical regulatory writing experience in pharma/biotech/CRO.
• Experience authoring and reviewing regulatory documents and CSRs.
• Ability to interpret clinical trial data and complex methodologies.
• Excellent writing, editing and proofreading skills; able to work under pressure.
• Ability to work independently and within a team; meets tight deadlines.
• English proficiency is mandatory; strong interpersonal skills essential.
• Proficiency with document management tools such as Veeva and MS Office.

Mansioni

• Author, review, and edit regulatory documents including CSRs and study protocols.
• Support development of CTD Module 2 summaries and regulatory submissions.
• Ensure deliverables meet regulatory requirements 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

Editing & proofreading

Independent worker

Deadline management

English proficiency

Interpersonal skills

Veeva

MS Office

Formazione

Bachelor's or Master's in life sciences

Strumenti

Veeva

MS Office

Descrizione del lavoro

Cardinal Health Ireland seeks an experienced regulatory writer to join our first medical writing team in Ireland, supporting client partnerships on clinical study reports, regulatory submissions, and CTD modules. You will collaborate with cross-functional teams and manage timelines.

The role requires a life science degree, 2–3 years in pharmaceutical writing, strong writing/editing skills, and the ability to work independently in a fast-paced environment.