Medical Evidence & Project Lead (all genders)

Stellenbeschreibung

Together, we break through as Medical Evidence & Project Lead (all genders)

Make your mark :

Leadership and management :

• Provides leadership and oversight of activities related to strategic planning and execution of real-world evidence studies and projects initiated by Medical Affairs team at AbbVie Germany.
• Lead employee(s), including supervision of activities, motivation and hiring support and skill development.
• Identifies, assess and elevates to line manager, issues that impact compliance, quality, timelines, budget, resource allocation and work to develop a resolution to reduce impact and develop alternative solutions.

Strategic evidence planning and consultancy

• Gives methodological and operational advice and guidance for evidence generation to TA Leads, Affiliate Medical Director and local evidence teams.
• Delivers scientific expertise in relevant therapeutic areas to assure high quality evidence plans and launch readiness prior to launch regarding RWE, with close alignment to early pipeline teams.
• Guidance on and review of scientific concept development, study protocol writing, statistical background, assuring alignment between scientific gap, research question, objective and endpoints.

Evidence project management

• Operational project management of evidence generation projects / studies from a methodological and operational perspective
• Ensures that non-interventional Studies (NIS) are performed in compliance with German Drug Law and in accordance with the recommendations of BfArM / PEI
• Ensures timely execution of research projects and studies in accordance to defined KPIs, timelines and budget.
• Optimizes study execution and implements action plan to ensure evidence generation and business objectives are successfully met;

ensures alignment of local evidence generation activities with global initiatives.

High level oversight of external vendors and research partners

Further responsibilities

• Operational support of compassionate use programs (CUP) in compliance to German drug law and internal standards
• Project management of initiator-initiated studies (IIT)
• Support database management and IT compliance
• Initiates, monitors and manages internal projects by achieving highest quality standards and adherence to local guidelines and AbbVie SOPs.

Qualifikationen

This is how you can make a difference :

• Bachelor’s Degree or equivalent in related science field 3 years pharmaceutical industry experience; including a minimum of 2 years in pharmacovigilance quality systems.
• Affiliate experience strongly preferred Good knowledge of global pharmacovigilance regulations, including one or more countries with an excellent understanding of PV quality assurance systems
• Skilled at technical writing and authoring, including SOPs / procedural documents, corrective actions plans / exception reports Good Excel, data interrogation and interpretation skills and experience Good influencer across multiple stakeholders;

seen as a collaborative partner across the organization Able to proactively identify, assess, and effectively manage compliance risks Experienced in working in cross-functional teams

• Analytical with a high degree of attention to detail
• Very good written and spoken English plus one other language

Here's how we can move mountains together :

• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy work-life balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with top-tier, attractive development opportunities
• with a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance.

We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis.

We are committed to equality, equity, diversity and inclusion (EED&I) a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

Zusätzliche Informationen

Nur gemeinsam können wir das Beste für Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit, Vielfalt & Inklusion.

Wir gestalten ein Arbeitsumfeld, in dem alle Mitarbeiter ihr Potenzial entfalten können unabhängig von Geschlecht, Herkunft, Religion, sexueller Orientierung oder anderen Vielfaltsdimensionen.

Doch für uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu berücksichtigen : Sie bezieht sich auch auf unterschiedliche Ausbildungshintergründe, Fachkenntnisse, Persönlichkeitstypen, Denkweisen und Lebenserfahrungen.