Back to jobsYou ensure the continuous proof of efficacy and safety for our developed products across all life‑cycle stages.
Furthermore, you also provide qualified responses to scientific and regulatory questions related to trial design, evidence requirements, and portfolio selection
In addition, you will represent our clinical development in interdisciplinary generic development teams with emphasis on clinical trials of medicinal products.
As Trial Manager, you plan, coordinate, and supervise clinical and/or pre‑clinical studies in line with regulatory guidelines and maintain quality management of the entire trial program. This also includes consultation and design of trial concepts with competent authorities and the preparation of scientific advice packages.
Part of your role will also include tasks as a Medical Writer, where you prepare and review scientific documentation on the efficacy and safety of our products. Here, you ensure the timely preparation of non‑clinical and clinical documentation for regulatory submissions, including the commissioning and review of modules 2.4 and 2.5.
In doing so, you respond to deficiency letters during registration procedures and manage corresponding customer inquiries.
Moreover, you identify, select, commission and collaborate with national and international service providers (CROs, monitors, consultants), including auditing and ensuring proper investigational medicinal product handling in line with GCP and GMP requirements.
Lastly, you collaborate with the project teams in due-diligence processes and evaluate dossiers as part of in‑licensing activities.
