A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
You are reporting to the Head of Global Epidemiology. As epidemiologist, you contribute to the development of the Real-Word Data (RWD) strategy (mainly for regulatory purpose) for compounds within key strategic therapeutic areas under your responsibility, by being able to integrate global and regional development needs. You act as the Study Lead for Non-Interventional Studies (NIS) you oversee:
- Adequately and timely design, plan, initiate, and monitor standard NIS (including protocol development and study report writing) with limited or without supervision
- Ensure alignment for all functions’ needs regarding the NIS within the Study Team
- Ensure adequate oversight of all partners (e.g., statistician for the SAP, analyst for the data analysis, the potential ARO/ CRO for the study execution in close relationship with the dedicated functions), including quality oversight of deliverables
- Critically review and co-author the NIS reports and any publications, ensuring the accuracy of the results and its interpretation
- You also contribute to the critical review of assessments, expert statements, publications, and study proposals from internal and external sources, timely and appropriately develop epidemiological sections for submission relevant documents, such as the Risk Management Plan, other safety documents (e.g., DSURs…), and any regulatory documents, understand and follow all Global Epidemiology-related SOP/ WIs and relevant Standards as well as any other relevant internal documents, and contribute actively to achievement of team goals.
Who you are:
- Bachelor’s degree with 3 plus years of experience, or master’s degree in health science, epidemiology, public health, or related field minimum requirement
- Two plus years in pharmaco-epi research projects preferred
- Two plus years working with observational databases preferred
- Two plus years in pharma & good understanding of clinical development preferred
- Working in matrix organization: creative, problem solver, collaborative, organized, effective communicator
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
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