Precision Medicine Group - Regulatory and Start Up Specialist

• contracts and budgeting negotiation experience • for Germany. • Apart from Germany, this position will be also covering  regulatory submissions and site contract and budget negotiation in Austria and Switzerland. • Essential functions of the job include but are not limited to: • Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site • Review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits. • Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. • A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. • At least 2 years of relevant experience. • Previous experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. • Strong communication and organizational skills. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Fluency in English and German • Preferred: • Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. • Experience in site contract and budget negotiation. • Experience using milestone tracking tools/systems. • Ability to prioritize workload to meet deadlines • Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science. • Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.