RWD/ RWE Manager (f/m/d)
PAUL HARTMANN AG Heidenheim an der Brenz Vollzeit
Responsibilities
- Design and implement RWD and RWE strategies to generate clinical, safety, and economic evidence for medtech products
- Collaborate with cross-functional teams within Evidence Generation Department (Clinical Trials, Evidence Synthesis, Health Economics, and Diagnostic/Prognostic Research), and beyond, including regulatory, clinical affairs, market access, marketing, and sales to integrate RWE into product development and lifecycle management
- Develop study protocols, including observational studies, registries, and post-market surveillance, to gather and analyze real-world data
- Lead data extraction, cleaning, analysis, and interpretation from diverse real-world data sources such as electronic health records (EHR), claims data, patient registries, and wearables
- Communicate RWE findings through reports, scientific publications, white papers, and presentations to internal stakeholders, regulatory authorities, and external audiences
- Ensure compliance with applicable regulatory guidelines and industry standards for data privacy, security, and ethical use of patient data
- Stay up to date with emerging trends and technologies in real-world data and evidence generation, and apply innovative methods to optimize RWD and RWE strategies
- Advanced degree in epidemiology, biostatistics, health economics, public health, data science, or related fields
- 3+ years of experience in generating real-world data (RWD) and evidence (RWE), preferably in medtech, pharma, or healthcare
- Proven experience with real-world data sources (EHR, claims, registry data) and RWE studies for regulatory or HTA purposes
- Proficiency in statistical programming and data analysis tools (SAS, R, Python) and familiarity with RWD platforms (e.g., Flatiron, IQVIA)
- Strong knowledge of real-world study designs (retrospective cohort, case-control, registry-based) and global regulatory requirements (FDA, EMA)
- Expertise in GDPR, data privacy laws, and health economic models with evidence synthesis
- Strong project management, communication skills, and experience in medtech or digital health solutions
- Flexible working conditions, such as flexible working hours and mobile working
- Attractive ways of combining work and family life, e.g. childcare subsidy
- 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
- Company pension plan with attractive employer contribution incl. matching model for deferred compensation
- Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
- Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
- Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc
- Job Bike Leasing
- Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform
PAUL HARTMANN AGHeidenheim an der Brenz
Responsibilities
• Provide expert advice on Health, Safety, and Environmental (HSE) matters, including conducting audits and compliance monitoring
• Develop, implement, and maintain environmental management systems to ensure regulatory compliance...
PAUL HARTMANN AGHeidenheim an der Brenz
Responsibilities
• Provide expert advice on Health, Safety, and Environmental (HSE) matters, including conducting audits and compliance monitoring
• Develop, implement, and maintain environmental management systems to ensure regulatory compliance...
PAUL HARTMANN AGHeidenheim an der Brenz
Aufgaben
• Verantwortung übernehmen: Inhaltliche und kommerzielle Verantwortung für die zugeordneten Einkaufsgemeinschaften (Markt-, Kunden-, Stakeholdermanagement, Preis- und Konditionengestaltung)
• Aktive Steuerung: Management der relevanten...
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