Medical Evidence & Project Lead

Company DescriptionPeople.
Passion.
Possibilities.
Three words that make a world of difference.More than a job.
It's a chance to make a real difference.Welcome to AbbVie! As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrow's unmet medical needs in close collaboration with your colleagues.
Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities for developing and increasing your own skills? You've come to the right place!People.
It's who we are, what we do, and what we stand for.In our Medical Affairs team at the Wiesbaden site, you will be working in a team of talented people and experienced management experts.
Through valuable analyses and research efforts, you will support improving patient care by leading and implementing real-world evidence studies and projects. 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 the Medical Affairs team at AbbVie Germany.Lead employee(s), including supervision of activities, motivation, hiring support, and skill development.Identifies, assesses, and elevates to line manager, issues that impact compliance, quality, timelines, budget, resource allocation and works to develop a resolution to reduce impact and develop alternative solutions.Strategic evidence planning and consultancyGives 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 managementOperational 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 with defined KPIs, timelines, and budget.Optimizes study execution and implements action plans 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 responsibilitiesOperational support of compassionate use programs (CUP) in compliance with 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 the highest quality standards and adherence to local guidelines and AbbVie SOPs.QualificationsThis is how you can make a difference:
Bachelor's Degree or equivalent in a related science field with 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.Additional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visit ***/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
***/join-us/reasonable-accommodations.html
•