Regulatory affairs Manager (CMC Author) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Regulatory Affairs manager (CMC author) - Homebased in UK, Poland, Spain or Germany As a Regulatory Affairs manager (CMC author) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. We are seeking a highly motivated and qualified regulatory CMC author/writer for the Global Responsible for global CMC regulatory strategies and activities for a large Pharma portfolio through clinical development, market launch and product lifecycle management. What you will be doing: - Managing routine CMC authoring and submission activities for an assigned products or product portfolio to assure the preparation of high quality and compliant global regulatory submission. - Maintains regulatory CMC dossier templates in alignment with current ICH and relevant regional regulatory requirements and standards Maintains a core source file management system to support all global plasma CMC submission activities - Keeps current on global global submission requirements, standards and formats. - Assures an effective collaboration with Global Regulatory Affairs CMC Strategists, Global Manufacturing and Global Quality SMEs for the timely preparation and review of regulatory submission documentation. - Acts as liaison with relevant regulatory operations teams (e.g, Publishing) Supports the development of efficient submission authoring and preparation procedures to assure timely completion of submission packages per business and regulatory timelines - Helps maintain relevant submission-related systems and trackers and assures that global CMC regulatory submission documentation is consistent in terms of content and alignes with the global dossier templates. - Identifies country-specific submission requirements. - Collaborates with Global Regulatory CMC Strategists to define detailed scope of submissions. - Coordinates document review sessions to collate comments and corrections of drafted documents and prepares the documents for final approval for timely submission. You are: - A minimum of an undergraduate degree in a life-sciences discipline (or be a licensed healthcare professional). - The role requires a demonstrated experience in global pharmaceutical/biotechnological drug development and knowledge of the global regulatory CMC environment. • Experience in authoring and managing components of regulatory submissions • Knowledge of global regulatory requirements. • Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve development and commercial goals. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

• Collaboratively develop and continually refine product roadmaps based on our strategy and investment priorities for the platform capabilities that enable the end-to-end product strategy • Develop a deep understanding of customer needs/pain points through regular, direct interaction with customers or analysis of feedback and translate them into clear problem statements • Develop rapport and trust with business owners, engineering, architecture, and other key stakeholders • Draft business cases with the business value and success metrics well-defined • Support quality management efforts by assuring that the aggregate results of the teams are systematically integrated (i.e. performance, security, reliability requirements and other non-functional requirements are met) • Evaluate and share via reports and/or dashboards product performance and KPIs • Communicate the product vision clearly and comprehensively so that all stakeholders understand the scope of work and intended behavior of the final product • Recognize the impact of change on others and effectively lead change management efforts • Work with our research teams to define, measure, and improve the efficacy of our digital products • Keep abreast of industry trends, technologies, and competitive analyses to identify new opportunities and initiatives which ultimately serve the long-term product strategy • Continuously update knowledge of emerging AI trends and tools that impact product work • Experiment with AI to streamline discovery, planning, and delivery processes, improving efficiency without compromising product or customer outcomes

Unser Kunde ist ein weltweit operierender Full Service-Logistikdienstleister. Innovationskraft, flache Hierarchien und neue Technologien zeichnen das moderne Unternehmen aus. Zur Erweiterung des Teams suchen wir deutschlandweit (Remote oder an einem Standort unseres Kunden) den IT Expert WMS (m/w/d) Aufgaben - Zentrale Drehscheibe: Sie agieren als kompetente Schnittstelle zwischen den operativen Einheiten (Key Usern), dem IT-Plattformbetrieb sowie externen IT-Partnern. - Release-Management: Sie verantworten die fachgerechte Auslieferung und Implementierung von Softwarereleases auf Test- und Produktivsystemen. - Systemverantwortung: Sie betreuen und optimieren die WMS IT-Plattform und stellen deren Ver- fügbarkeit im Logistikalltag sicher. - Beratung: Sie beraten die Standorte bei der Umsetzung neuer Anforderungen und unterstützen bei Bedarf bei der Überführung in präzise User Stories und Testpläne. - Expert Support: Als fachliche Ansprechperson lösen Sie komplexe Problemstellungen im WMS-Umfeld. - Hands-on Troubleshooting: Gemeinsam mit den Key Usern analysieren Sie Fehlermeldungen, füh- ren Konfigurationen durch und beheben Störungen nachhaltig. - Enabling: Sie unterstützen und befähigen die Key User an den Standorten durch gezieltes Coaching und Support im Tagesgeschäft. - Qualitätssicherung: Sie erstellen verständliche Systemdokumentationen, um ein einheitliches Wissensniveau sicherzustellen. Qualifikation - Studium oder Ausbildung im Logistikumfeld oder eine vergleichbare praktische Qualifikation. - Fundierte Berufserfahrung in einer vergleichbaren Funktion und sehr gutes Verständnis der logisti- schen Geschäftsprozesse, insbesondere im Warehouse-Umfeld. Idealerweise Kenntnisse von PSIwms. - Erfahrung mit WMS-Systemen, vor allem in Bezug auf deren Konfiguration und Betreuung. - Hohe IT-Affinität sowie ausgeprägte analytische Fähigkeiten. - Starke Kommunikationsfähigkeiten, insbesondere als Schnittstelle zwischen Fachbereich und IT. - Gute Deutsch- und Englischkenntnisse in Wort und Schrift. Für Fragen steht Ihnen Herr Kothmann telefonisch gerne unter 0201 8945 364 zur Verfügung. Logistik-Consultants ist ein führender Anbieter im Bereich der Personalvermittlung in und um die Logistik. Die entsprechende Expertise, gepaart mit einem hervorragenden Netzwerk und einer entsprechenden Erfahrung der Mitarbeiter und Partner ermöglicht es uns, geeignete Kandidaten zu identifizieren und mit den passenden Unternehmen zusammenzuführen.

Management Level: 9 – Specialist/Team Lead- Program Management Location: Hyderabad, Bangalore Must have skills: Program Planning & Execution, Stakeholder & Team Management, Curriculum Development Coordination, Learning Platform (LMS) Management, Data-Driven Decision Making, Budgeting & Resource Allocation, Process & Quality Management, Performance Tracking (KPIs, OKRs), Cross-Functional Collaboration and Excellent Communication & Presentation Skills. Good to have skills: Leadership, Experience in EdTech Operations, Knowledge of Instructional Design & Learning Pedagogy Experience: 6+ years of experience is required Educational Qualification: Graduate (MBA Preferred) Job Overview: We are seeking a detail-oriented and proactive Specialist /Team Lead - Program Management to support the planning, execution, and delivery of learning programs. The ideal candidate will work closely with cross-functional teams to ensure smooth program operations, high participant engagement, and strong stakeholder satisfaction. Key Responsibilities Support end-to-end program management, ensuring timely and high-quality delivery of learning programs Assist in program planning, scheduling, resource coordination, and execution Track program progress, monitor key performance metrics, and generate reports for stakeholders Identify operational gaps and support implementation of process improvements Coordinate with internal teams, academic partners, and learners to ensure seamless program delivery Help maintain high program completion rates and participant satisfaction Support stakeholder communication and ensure alignment with program objectives Assist in managing program budgets and optimizing resource utilization Contribute to enhancing the learning experience through feedback analysis and continuous improvement initiatives Required Experience, Skills, and Qualifications Graduate with 6+ years of relevant experience in program management, operations, or a related field Prior experience in the EdTech industry is preferred Excellent communication skills (written and verbal) Strong organizational and coordination skills with attention to detail Good stakeholder management and relationship-building abilities Strong analytical skills with the ability to track and interpret performance metrics Ability to work in a fast-paced environment and manage multiple priorities Proficiency in tools such as Excel, project management platforms, and reporting dashboards About us Backed by a $1 billion investment over three years, Accenture launched its LearnVantage business in March 2024, providing comprehensive learning and training services to help organizations reskill and upskill their people and achieve greater business results in the AI economy. Powered by an AI-native platform, Accenture LearnVantage offers learning strategy and design, personalized learning experiences, learning managed services and certifications, all supported by a robust partner network and access to more than 2,000 mentors around the world. For more information, please visit www.accenture.com/learnvantage About Accenture Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.Visit us at www.accenture.com Equal Employment Opportunity Statement We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, military veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicable law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.