Regulatory and Start Up Specialist

Kurz zusammengefasst

Precision for Medicine is a global Clinical Research Organization that focuses on precision medicine. The company combines innovative clinical trial designs, expert operational and medical teams, advanced biomarker and data analytics solutions, and a strong commitment to rare diseases and oncology, along with work in other therapeutic areas. The company is looking for a Regulatory and Start Up Specialist based in Germany to join their growing team. The main day-to-day responsibilities include ensuring timely and quality site activation readiness within assigned countries and sites, and mitigating any risks. This involves preparing Clinical Trial Application Forms, submission dossiers, and handling responses from Competent Authorities and Ethics Committees. The role also includes maintaining project plans, regulatory intelligence tools, and communicating with various key functions involved in country start-up. Additionally, the specialist will support the negotiation of study budgets, investigator contracts, and site outreach for feasibility assessments. The must-have requirements for this role include a Bachelor's degree in life sciences or a related field, or being a Registered Nurse (RN), or an equivalent combination of education, training, and experience. At least two years of relevant experience is required. Fluency in English and German is essential. Previous experience working as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry is also necessary. Strong communication and organizational skills, as well as experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail, are required. Nice-to-have skills include relevant regulatory and site start-up experience, particularly in feasibility, contract negotiations, and CA/EC/IRB submissions. The role is based in Germany and covers regulatory submissions and site contract and budget negotiations in Austria and Switzerland as well. The team is growing, and the role offers opportunities for professional development. What the role asks for: - Bachelor's degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience. - At least 2 years of relevant experience. - Fluency in English and German. - Previous experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/biotech industry. - Strong communication and organizational skills. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail. - Nice-to-have: Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience.