When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are seeking a highly organized and collaborative Regulatory Affairs Generalist to support a strategic pharmaceutical partnership and its associated development and commercial programs. This role is dedicated to providing end‑to‑end regulatory affairs support for partnered assets, working closely with internal teams and external alliance stakeholders to ensure regulatory excellence across clinical, submission, and post‑approval activities. Serving as a key regulatory interface within the partnership, the Regulatory Affairs Generalist plays a critical role in regulatory planning, documentation management, submission execution, and ongoing compliance with global regulatory requirements. The ideal candidate thrives in a dynamic, cross‑company environment, effectively balances multiple priorities, and brings strong communication, problem‑solving, and collaboration skills to support successful partnership outcomes. The Regulatory Affairs Generalist provides comprehensive support across clinical, submission, and post approval regulatory activities for assigned pharmaceutical products and development programs. This role works cross functionally to ensure operational excellence in regulatory planning, documentation management, submission execution, and compliance with global regulatory requirements. The ideal candidate thrives in a dynamic environment, is highly organized, and demonstrates strong communication and problem-solving skills. Key Responsibilities 1. Regulatory Archiving & Documentation Management - Maintain U.S. regulatory archive logs, including: - Recording new submissions. - Archiving regulatory authority correspondence. - Upload and manage correspondence from global partners for assigned programs. - Ensure proper indexing, version control, and compliance using Regulatory Information Management (RIM) systems, electronic document management systems (EDMS), or other applicable archiving tools. - Ensure records are complete, audit ready, and aligned with internal SOPs and regulatory expectations. 2. Clinical Regulatory Support - Maintain and update trackers for Form FDA 1572 waiver requests and other clinical regulatory documentation. - Conduct GLP reviews of study documentation on behalf of Regulatory Affairs to support IND level compliance. - Author 1572 waiver requests and support routine regulatory submissions for clinical investigators. - Attend cross functional clinical trial team meetings as the Regulatory Affairs representative, providing regulatory interpretation, updates, and risk assessments. 3. Regulatory Submission Preparation - Draft administrative components of regulatory submissions, including: - FDA forms - Cover letters - Submission metadata and other supporting documents - Build and organize electronic submission structures using RIM systems or industry standard submission planning tools. - Manage internal workflows and approval processes to ensure timely completion of submission components. - Coordinate submission package delivery through established publishing workflows and oversee communication with submission/publishing teams. 4. Global Regulatory Team (GRT) & Cross Functional Collaboration - Prepare presentation materials and slide decks for Global Regulatory Team (GRT) meetings, governance discussions, and alliance meetings. - Serve as the Regulatory Affairs representative in partner or alliance meetings for assigned products, providing updates and tracking action items. - Support ongoing cross functional program meetings as needed, ensuring regulatory deliverables and timelines remain on track. 5. Authoring & Reviewing Regulatory Submissions - Contribute to the drafting, review, and preparation of regulatory submissions across development phases, including: - FDA meeting requests - Briefing documents - Applications for special regulatory designations (e.g., Fast Track, Orphan Drug Designation) - IND submissions, amendments, and associated documentation - Ensure content is scientifically sound, consistent, clear, and aligned with regulatory standards and internal templates. 6. Post Approval Regulatory Maintenance - Prepare, review, and submit periodic post marketing regulatory reports for assigned products, including: - PADERs (Periodic Adverse Drug Experience Reports) - NDA Annual Reports - DSURs (Development Safety Update Reports) - PBRERs (Periodic Benefit Risk Evaluation Reports) - Maintain tracking and compliance with global post approval commitments, submission deadlines, and regulatory requirements. - Support lifecycle management activities to ensure continued product compliance. Skills: - Project management knowledge - Client-focused approach to work - Results orientation - Teamwork and collaboration skills - Consulting skills - Excellent interpersonal and intercultural communication skills, both written and verbal - Critical thinking and problem-solving skills - Proficiency in local language and extensive working knowledge of the English language Knowledge and Experience: 5+ years of related regulatory affairs experience in an industry-related environment Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred. Other: Due to the client’s location, candidates located in the Eastern or Central time zones of the US or Canada are preferred. The ability to travel up to 20% may be required. #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

POSITION DETAILS: Position Title: Adoption & Change Management Consultant (12 month FTC) Reports to (POSITION): Adoption & Change Management Lead Team: Microsoft Services Team Department: Technical Solutions Grade (If Applicable): PURPOSE OF JOB: (OVERALL DESCRIPTION OF THE POST WITHIN THE TEAM AND ORGANISATION) The Adoption & Change Management Practitioner supports the Adoption & Change Management Lead in driving the successful adoption and utilization of M365 technologies. This role involves assisting with change management initiatives, developing training materials, and providing support to end users. KEY RESPONSIBILITIES: - Assist in the development and implementation of adoption and change management strategies for M365 technologies. - Support the creation and delivery of training materials, including videos, to support user adoption. - Collaborate with stakeholders to identify and address barriers to technology adoption. - Monitor and report on adoption metrics and user feedback. - Ensure best practices are followed in the use of SharePoint, including page design, administration, and permissions management. - Adoption and Change Management for Copilot - Training sessions with customers for applications across the M365 estate. INDIVIDUAL RESPONSIBILITIES: - Conduct workshops and training sessions for power/super users. - Design and manage SharePoint pages, ensuring they meet organizational needs. - Assist end users with navigating SharePoint, finding and saving files, and managing file access. - Assist end users with tips and tricks for using Word, Excel, Teams, OneDrive - Develop and maintain documentation on best practices for M365 apps. WIDER TEAM NETWORK (WHICH TEAMS WILL THE POSITION WORK WITH DIRECTLY AND WHO WILL THEY RELATE TO EXTERNALLY) Internal - Pre-sales, Sales, Marketing and Support External - Clients, Vendors and Partners QUALIFICATIONS, EXPERIENCE, & SKILLS: (DELETE AS REQUIRED IF ESSENTIAL OR DESIRABLE, REMOVE UNNECESSARY REQUIRENENTs) Educational Qualifications: - ESSENTIAL Professional Qualifications - Strong knowledge of M365 technologies, including SharePoint and Copilot. ESSENTIAL - Excellent communication and organizational skills. ESSENTIAL Years of Experience - 2+ years of experience in change management, user adoption, or a related role. ESSENTIAL Other Requirements - Ability to work collaboratively with cross-functional teams. ESSENTIAL - Strong analytical and problem-solving skills. DESIRABLE - Experience in creating and delivering training materials. DESIRABLE CORE Competencies & SKILLS – BASED ON POSITION AND GRADE (IF APPLICABLE) (INCLUDE CORE COMPETENCIES & SKILLS REQUIRED FOR THIS POSITION BASED ON THE GRADE) - Change management expertise - Proficiency in M365 technologies (SharePoint, Teams, OneDrive, Word, Excel) - Strong presentation and training skills - Excellent organizational and project management abilities MEASURES & GOALS (HOW WILL THE SUCCESS OF THE PERSON IN THIS POSITION BE MEASURED – WHAT ARE THE EXPECTED OUTPUTS) OBJECTIVE MEASURE FREQUENCY

We are looking for SIEM & SOAR Consultant. Details: Contract: B2B Start: May 1, 2026 End: September 30, 2026 (with possible extension) Workload: full-time (100%) Location: remote (EU-based candidates only) Language: English Responsibilities: - Design, deploy, and maintain automations within XSIAM environment - Develop and manage Palo Alto XSIAM playbooks and workflows - Support security incident handling and automation of response processes - Collaborate with internal security and infrastructure teams - Assist with root cause analysis and incident investigations - Implement pre-approved operational changes within security systems - Ensure stable and compliant operation of XSIAM services Requirements: - Strong experience with Palo Alto XDR/XSIAM - Experience with Palo Alto XSOAR - Hands-on experience with SIEM technologies (advanced level) - Understanding of security incident workflows and automation Nice to have: - Experience in cloud information security - Experience with Cyber Threat Intelligence (CTI) platforms - Scripting experience (Python)

• Contactar a los comercios por medios digitales y ofrecer DEMOS de nuestro sistema POS • Resolver dudas e inquietudes sobre planes de adquisición del sistema y postventa del mismo • Vistas a comercios para levantamiento de requerimientos técnicos o comerciales y puesta en marcha de la solución • Cumplimiento de indicadores de venta (afiliaciones a POS), renovaciones, y demostraciones diarias de posibles prospectos • Asegurar el proceso de envio de cotizaciones, cierre de ventas y programación del onboarding con el agente especializado