Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs. RESPONSIBILITIES Acts as
solutions to projects, mentors team members, to support scope of project workPartner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support
guidance and solutions to projects, mentors team members, to support scope of project work Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement
enhancing our global network of regulatory science and strategy capabilities to support life science clients to use Real World Evidence more widely and effectively for regulatory purposes. Secondly, the
Fulltime / permanent/ non-tariff Do you want to work in a global team and support regulatory strategies of plasma-derived products in all phases of development, from preclinical to post approval phase
Daiichi Sankyo Europe GmbH sucht in eine/n Specialist Administration & Support (m/f/x) Regulatory Affairs (ID-Nummer: 12098448)
Dr. Neuberger Holding GmbH sucht in eine/n Regulatory Support Specialist (m/w/d) in Vollzeit oder Teilzeit (mind. 30 Stunden) (ID-Nummer: 11986139)
. application for new licenses for the LUNADIS (e.g. e-money license) as well as approval or approval procedures with (third-party) providers of services.You accompany and support the preparation of the risk
discussion on a protocol) Manages CTAs activities related SOPs (ie. Coordinates the creation, updates of the QDs) Identify any issues and propose resolution Provide support to Development Safety Update Report
discussion on a protocol) Manages CTAs activities related SOPs (ie. Coordinates the creation, updates of the QDs) Identify any issues and propose resolution Provide support to Development Safety Update Report
standards of patient safety and product efficacy. Today, we are setting new standards in digital urology to provide holistic care to patients seeking treatment and support the community on their road to
. Christmas and holiday bonuses Option of permanent employment with our business partner Free online courses Up to 30 days vacation per year Ihre Aufgaben Provide support to complete product dossiers, technical
. Christmas and holiday bonuses Option of permanent employment with our business partner Free online courses Up to 30 days vacation per year Ihre Aufgaben Provide support to complete product dossiers, technical
Job Overview: As Associate Director, you will liaise with cross-functional teams, to drive the quality statistical planning, analysis and reporting in support of pharmaceutical development and
vulnerabilities. Support quality management with penetration testing and system hardening.Regulatory responsibilitiesAssess regulatory requirements on their applicability on products for Dornier Implement
medical devices) Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included Qualifications: University Degree in life science
that support flexible work schedulesPrograms to help you build your therapeutic knowledgeDynamic work environments that expose you to new experiencesHome-office, company car, accident insurance and more
Saxony-Anhalt, to support clinical research projects mainly in the Eastern Germany region. When you join IQVIA as a sponsor-dedicated CRA2 or SrCRA1 (m/w/d), you’ll enjoy the stability and resources of
department.Serve as a member of the PSCS Leadership team, ensuring cross-functional collaboration to support growth plans. Qualifications: Education: Bachelor’s Degree required; advanced degree
responsibilities be? Set governance standards for Quality (for both regulated and non-regulated) across MLEMEALead the innovation agenda for Quality in support of 2020 agendaMeasure regional Service Quality versus
, Research & Development Quality Assurance (R&DQA) and Clinical.Maintains up-to-date understanding of safety profiles of registered and investigational products. Supports and collaborates with cross-functional
. The Role Lead and manage a team of event and contract administration specialists.Define goals and objectives with team members to achieve short-term operational results.Provide guidance and support
companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and
companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and
patients.Develop clinical trial supply documents and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product (IMP) Manuals, product preparation and administration
in partnership with other functional areas to achieve clinical research target.Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support
WELLPASSDiscounted Germany ticket for bus and trainFree coffee and water, company restaurants and cafésBicycle leasing and numerous employee benefitsCompany pension plan with HELLA allowanceFamily support: family
. Additional tasks: • Collaborates with CR&D staff regarding data analysis requests. • Performs additional statistical analyses including but not limited to: o support responses to regulatory agencies, o
support statistical programming activities related to the analysis of real-world data. This role involves working closely with biostatisticians, epidemiologists, clinical scientists, medical affairs, health
implements a process for data integrations between systems utilized to support clinical studies. Leads and supports projects to implement the agreed Clinical Data Standards within Clinical Development
subcontractor compliance and audit programsCommunicate EHS standards and ensure site complianceReport, record, and analyze EHS eventsAdvise on legal and EHS concerns and support Management of ChangeImplement
repercussions Support and implementation of risk analyses, certifications and audits Monitoring compliance-relevant laws, guidelines and best practices Supporting compliance investigations as required (focus on
Support activities ensuring compliance with the AI Act. Develop simple AI use cases. Train models for the developed AI use cases. Assist in communicating AI and data science-related developments within the
Support activities ensuring compliance with the AI Act. Develop simple AI use cases. Train models for the developed AI use cases. Assist in communicating AI and data science-related developments within the
management to support organizational needs, ensuring effective communication and transition strategies Support talent acquisition plans by overseeing recruitment activities in collaboration with the according
card, discounted meal at our canteen, support for commuting to work, support for sport activities Reliable and stable company Creative and dynamic working environment Flexible working time Ensuring work
financial repercussions Support and implementation of risk analyses, certifications and audits Monitoring compliance-relevant laws, guidelines and best practices Supporting compliance investigations as
, discounted meal at our canteen, support for commuting to work, support for sport activities Reliable and stable company Creative and dynamic working environment Flexible working time Ensuring work-life balance
and activities Up to 30 days of annual leave Personal support and qualified advice from the Aviation Unit offices, e.g. in Hamburg-Finkenwerder, Stade, Augsburg, Munich or Bremen Your prospective job
accumulated overtime for sabbaticals, special leave, or an early start into retirement (Marburg)Family services such as psychological support, legal advice, family care services and more for you and your direct
artificial intelligence and lead your own team for these topics.In this role, you will support the strategic direction for the division and structure and define processes and documentation for our business
datasets. 3. Develops and implements a process for data integrations between systems utilized to support clinical studies. 4. Leads and supports projects to implement the agreed Clinical Data
during the RFP/Bid Defense cycle. You’ll bridge the gap between sales, medical, and operational teams to ensure seamless project execution and support sales teams throughout the Business Development
non-IMP commercial products, to specific packaging designs and efficient distribution strategies Support investigations as Subject Matter Expert for assigned trials Unsere Anforderungen Master's degree
for New Product OpportunitiesUtilise insights from the product development pathway and global biopharmaceutical trends to guide R&D policy, support preparation of regulator packages and identify new
and develop a team comprised of process engineers and or scientistLead technical workstreams of complex projects at the site level or at the global level to support process changes, process improvements
common services b) Support the development of a comprehensive risk profile to prioritize mitigation actions 3. Work with Process Owners to Align the Cybersecurity Incident Response Plan (CSIRP) a
Weapons and Ammunition Division Extensive Employee Assistance Program to support overall health and wellbeing Career development and progress opportunities Individual and diverse training opportunities and
innovation pipeline with novel vaccine candidatesOversee multi-year, impactful projects, including planning and resource managementManage a laboratory team and support the professional growth of team
level – whether you are interested in vacancies in agile SMEs or international DAX groups. Hays masters the entire IT job spectrum, from support to software architecture or digitalisation – thanks to our