Country Study Manager / Local Quality Responsible

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La position

You are a strategic and process-oriented professional with subject matter expertise in Good Clinical Practice (GCP) with a passion for both evidence generation and quality management. This position offers the opportunity to be a key player in ensuring our evidence generation projects such as RWE and clinical trials are executed according to international standards and maintaining the high standards of our Quality Management System (QMS).

The Opportunity

As a Country Study Manager (CSM), you will :

Plan and implement clinical studies and / or other evidence generation projects : Have overall operational responsibility for the planning, initiation, and implementation of clinical studies or evidence generation projects in Norway, ensuring they align with internal and external procedures as well as the overall disease area strategies.

Provide expertise in evidence generation projects including clinical trials : Act as a resource person for internal colleagues and contribute to cross-functional teams related to clinical studies or evidence generation

Ensure Compliance : Oversee and manage evidence generation projects in compliance with applicable regulations, protocols, and timelines.

Collaborate in cross-functional teams and cross-country networks : Ensure effective collaboration with international and cross-country networks, contributing to global study initiatives.

As a Local Quality Responsible (LQR), you will :

Implement and Lead the QMS : Drive the implementation of the global Roche QMS at the affiliate level, ensuring compliance with all local and international regulatory requirements.

Lead and maintain affiliate SOP management system within GCP and GVP.

Manage Medical Compliance : Oversee and lead the affiliate's medical compliance processes, including risk management and quality monitoring strategies.

Provide Quality Oversight : Lead and act as a trusted quality partner, supporting audits and inspections, and proactively identifying and mitigating risks.

Champion Quality Culture : Promote and advocate for an enterprise-wide quality culture by acting as a Visionary, Architect, Coach, and Catalyst (VACC).

Service provider oversight : Oversight of service providers within GCP and PV.

Who You Are

You thrive in a dynamic collaborative environment which is highly regulated. In this role, you are able to transition between strategic oversight and operational hands-on execution.

Education : A university degree in a medical or science-related field is preferred. Master in Pharmacy or equivalent.

Experience :

The preference is at least 5 years of professional experience in the biopharmaceutical industry.

Experience in audits and health authority inspections is highly desirable.

Demonstrated expertise in both QMS and clinical trial management is a strength.

Experience with real world evidence is a strength, either locally or regionally.

Applied and documented knowledge of ICH GCP, GVP, and other relevant regulations.

Knowledge or experience with medical devices is a plus but not a requirement.

Skills :

Exceptional partnering and networking capabilities.

Strong quality mindset, with the ability to influence and lead without direct authority.

Risk based and pragmatic mindset with the ability to focus where it matters and simplify in highly regulated environments

Excellent verbal and written communication skills in both English and Norwegian.

Highly self-motivated and able to lead initiatives with a focus on outcome-based planning.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd\'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l\'équité en matière d\'emploi.

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