Clinical Start-Up & Regulatory Analyst

Novo Nordisk A/S; Partido de Vicente López; Presencial; ARS 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Novo Nordisk A/S in Argentina is seeking a Study Start Up Analyst to help clinical trials get started on time and the right way. You will prepare and submit the documents that Health Authorities and Ethics Committees need to approve a trial.

When your work is accurate and fast, sites can start sooner, keeping research moving for people living with serious chronic diseases. You will own start-up and submission activities from the first plan to green light.

Formación

• University degree in Life Sciences, Pharmacy or related field.
• Experience in regulatory work for clinical trials at a CRO or pharma company and hands-on ICH GCP experience.
• Experience with trial systems such as CTMS and eTMF.
• Knowledge of regulatory submissions: local rules, dossier requirements and clinical trial applications.
• Advanced English.
• Sharp eye for detail and ability to organise and prioritise work.
• Team player mindset.

Responsabilidades

• Lead and coordinate preparation, review and submission of Health Authority and Ethics Committee dossiers for assigned trials, in line with ICH GCP, local regulations and Novo Nordisk processes.
• Co-develop the start-up plan with Trial Managers and plan and track regulatory milestones at country and site level.
• Adapt, translate and validate key documents – informed consent forms, patient materials, labels and CTA documents – including authority updates.
• Drive green light activities: collect essential documents, perform quality control, file in eTMF and keep local trial registries and safety submissions up to date.
• Identify site-level and compliance risks early, mitigate them, and support inspection readiness and audits.
• Share local regulatory insights with trial teams and regional/global colleagues, contributing to start-up improvements.

Conocimientos

Regulatory work experience

CTMS/eTMF knowledge

Documentation submission

Advanced English

Attention to detail

Team player mindset

Educación

University degree in Life Sciences/Pharmacy

Herramientas

CTMS

eTMF

Descripción del empleo

Novo Nordisk A/S in Argentina is seeking a Study Start Up Analyst to help clinical trials get started on time and the right way. You will prepare and submit the documents that Health Authorities and Ethics Committees need to approve a trial.

When your work is accurate and fast, sites can start sooner, keeping research moving for people living with serious chronic diseases. You will own start-up and submission activities from the first plan to green light.