Medical Evidence Project Lead

vor 1 Woche

Wiesbaden, Hessen, Deutschland AbbVie Vollzeit

Leadership and Management

The ideal candidate will provide 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.

Responsibilities include:

  • Leading employee(s), including supervision of activities, motivation and hiring support and skill development.
  • Identifying, assessing and elevating 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

The successful candidate will give methodological and operational advice and guidance for evidence generation to TA Leads, Affiliate Medical Director and local evidence teams.

Responsibilities include:

  • Delivering 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

The candidate will be responsible for operational project management of evidence generation projects/studies from a methodological and operational perspective.

Responsibilities include:

  • Ensuring that non-interventional Studies (NIS) are performed in compliance with German Drug Law and in accordance with the recommendations of BfArM / PEI.
  • Ensuring timely execution of research projects and studies in accordance to defined KPIs, timelines and budget.
  • Optimizing study execution and implementing action plan to ensure evidence generation and business objectives are successfully met; ensuring alignment of local evidence generation activities with global initiatives.
  • High level oversight of external vendors and research partners.

Further Responsibilities

The ideal candidate will also be responsible for:

  • 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.
  • Initiating, monitoring and managing internal projects by achieving highest quality standards and adherence to local guidelines and AbbVie SOPs.

Qualifications

The successful candidate will have:

  • 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.

What We Offer

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

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.

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