Medical Evidence & Project Lead (all genders)

Medical Evidence & Project Lead (all genders)

AbbVie

Wiesbaden, Germany

Job Description

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.

Qualifications

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

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Germany      Clinical Research      Medical      Pharmacovigilance and Medical Information      Quality Assurance      AbbVie