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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. As a Site Investigational Product Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What You Will Be Doing You will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it. The Site Investigational Product Specialist will serve as a key contact point between the sponsor and the investigational site for Investigational Product Preparation Instructions (IPPI) training of studies with a complex IP preparation process. This role will focus on IPPI review and training/implementation of IP preparation steps for all compounds deemed requiring training plans. The Site Investigational Product Specialist will be the key internal and external interface to ensure overall IPPI adherence . He/she will contribute to continuous process improvement, training and mentoring for IPPI. The Tasks Undertaken Are Varied And Can Include • Play a key role in the safe, efficient and effective Investigational Product preparation and administration in clinical trials., • Review and provide input on Investigational Product Preparation Instructions Site Investigational Product Procedures Manual, monitoring guidelines and all specific forms related to Investigational Product preparation and dosing before finalization as applicable., • Process risk assessment review where applicable., • Close collaboration with the Drug Product Development team and the Drug Preparation Administration Team., • Early connection with investigational site pharmacy and nursing staff to review site IP process and equipment., • Close collaboration with (Global Trial Lead) GTL, (Study Manager) SM, (Trial Manager) TM, Independent Drug Monitor (IDM) and Pharmacy Investigational Product Specialist (PIPS) for all IPPI related topics., • Evaluate and support process for IP ancillary supplies/administration kits are compatible with the site equipment/practice in the country/investigational site., • Review of site's dispensing and accountability records to ensure key information is captured to confirm dose delivery and administration is documented e.g. infusion rates/volumes., • Collaboration on Investigational Product training material development with key stakeholders., • Observe first dosing on site and/or support SM/IDM/PIPS if allowed according to local guidelines and blinding requirements., • Point of contact for the internal study team in the country for questions related to the IP administration., • Review any modification of IPPI, SIPPM manual, specific forms related to IP administration and dosing during the applicable phases of the trial., • Establish and maintain good and productive working relationships with internal and external stakeholders (e.g. nurses, investigators,…). You Are • A degree in general nursing is required., • 3- 4 years of recent clinical/hospital experience is required;, • Experience in antibody treatment, (Oncology (hematology and solid tumor) and / or Immunology Therapeutic Area), • Min. 3 years’ experience with various IP administration routes (IV, SC, IM), • Clinical trial research experience., • Minimum of 5+ years of recent clinical/hospital experience is required; however, other relevant experience may be considered by the hiring manager when considering the candidate’s eligibility., • Minimum of 5+ years’ experience with various IP administration routes (IV, SC, IM, intravesical, intraperitoneal, blood- and cell products) and priming and flushing procedures required., • Extensive knowledge on Administration related requirements (background of anatomy and physiology, metabolism of drugs and IP, hygienic requirements, how to handle hazardous drugs) 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our ___ 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 ___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 ___ to apply

Senior Clinical Research Associate – England Chloe O’Shea is proud to partner with a leading global CRO renowned for delivering innovative, high-quality solutions in clinical development. We are seeking an experienced Senior Clinical Research Associate (Senior CRA) to join a dedicated single-sponsor team in England. This is an exciting opportunity to work on cutting-edge studies, with a particular focus on advanced therapy areas such as CAR-T and gene therapy. While prior experience in these fields is highly valued, it is not essential - full training and support will be provided. The Role As a Senior CRA, you will be a key contributor to the successful delivery of clinical trials across England. You will oversee site management activities, act as a primary liaison with investigative sites, and ensure strict compliance with protocols, ICH-GCP, and UK regulatory requirements (MHRA/REC). This role is well-suited to ambitious CRAs ready to step up or established Senior CRAs seeking to deepen their expertise in innovative therapy areas. Key Responsibilities • Independently manage qualification, initiation, monitoring, and close-out visits across England., • Ensure high standards of compliance with ICH-GCP, MHRA, REC requirements, and sponsor SOPs., • Perform source data verification, investigational product accountability, and ensure accurate site documentation., • Serve as a trusted partner to site personnel, offering training, guidance, and ongoing support., • Identify site-level challenges proactively and drive timely resolution., • Contribute to mentorship of junior CRAs and share best practices within the monitoring team., • Maintain complete and accurate trial documentation in CTMS, eTMF, and EDC systems. Requirements • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related discipline., • Minimum 3 years of independent UK monitoring experience, ideally with exposure to complex studies., • Experience in CAR-T and/or gene therapy is highly desirable but not required., • Strong knowledge of ICH-GCP and UK clinical trial regulations (MHRA/REC)., • Excellent communication, relationship-building, and organisational skills. What’s in It for You? This role offers a competitive salary and benefits package, flexible working arrangements, and clear opportunities for career progression within one of the world’s largest CROs. You’ll gain exposure to innovative therapies shaping the future of healthcare, while working in a collaborative culture that values professional development, work-life balance, and wellbeing. If you are a driven Senior CRA — or an experienced CRA ready to take the next step — we’d love to hear from you. Apply today to join a global team making a meaningful difference in patients’ lives.

About BridgeBio Pharma, Inc. BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to late-stage clinical trials, across multiple therapeutic areas including precision oncology, cardiology, endocrinology, neurology, and renal disease. We have already achieved regulatory approval for three therapies and continue to advance promising science from academia into meaningful treatments for patients worldwide. Who We Are BridgeBio is a global biotechnology company with our Global Headquarters located in San Francisco, USA, and our International HQ located in Zug, Switzerland. Since establishing our European presence in 2021, we’ve been building empowered, high-performing teams across countries — with experienced colleagues who move quickly, take ownership, and are fueling the company’s international growth. At BridgeBio, you’ll find an energetic and collaborative culture where pragmatism meets bold decision-making. We embrace uncertainty with confidence, guided by our commitment to making a meaningful impact for patients. Our people are trusted and empowered, united by urgency, purpose, and the drive to advance science for patients around the world. To learn more about our story and company culture, visit us at ___What You'll Do You will report to the VP, Regulatory Affairs, International, and work closely with the EU Regulatory Lead, the International team, and relevant cross functional stakeholders in the US to drive strategic initiatives that support BridgeBio’s mission of delivering transformative medicines to patients with genetic diseases and genetically driven cancers. Your primary purpose will be to support the preparation, compilation and submission of an EU Marketing Authorization Application (MAA) for a small molecule orphan medicinal product. Working closely with the EU Regulatory Lead and cross-functional teams, the focus will be on critical submission activities with primary responsibility for eCTD module 1 preparation, EU label development and handling of all aspects of regulatory information management in Veeva RIM. This role requires effective collaboration with cross-functional colleagues and external stakeholders to ensure high-quality execution and impact. The ideal candidate combines deep expertise in major EU regulatory submissions, including hands-on preparation and filing responsibilities of an EU MAA with strong communication skills, adaptability, and the ability to thrive in a fast-paced, hands-on environment. Where You'll Work • If you are UK or Netherlands based: This is a fully remote role with occasional travel to our Switzerland Office Responsibilities • Support preparation, compilation, and submission of EU regulatory filings across multiple products and procedures., • execute eCTD Module 1 authoring, compilation, and QC, including:, • – eAF creation and validation, • – ensuring QRD compliance of SmPC/PL/labelling, • – Manufacturing authorisations, QP declarations, ODD documentation, • Manage regulatory data, metadata, records, and workflows in Veeva RIM, ensuring accuracy, compliance, and inspection readiness, • Coordinate timely submissions via EMA portals (IRIS, SPOR, OMS, Eudralink, etc.), • Compile, review, and perform quality checks for Module 1 components, including creation and validation of eAFs, • Ensure all submission packages meet regional requirements and internal quality standards prior to dispatch, • Collaborate with cross-functional teams (Regulatory, CMC, Clinical, Quality) to gather and verify required documentation, • Maintain submission records and monitor timelines to support efficient regulatory lifecycle management Who You Are • 5–8 years of experience supporting EU regulatory submissions, including hands-on preparation and filing responsibilities of major EU submissions (EU MAA preferred), • Strong proficiency with Veeva RIM for managing submissions, regulatory information and document workflows, • Working knowledge of EMA systems (IRIS, SPOR, and other submission portals), • Demonstrated expertise in compiling and reviewing eCTD Module 1 documentation and completing eAFs, • Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field (Master’s preferred), • Excellent attention to detail with the ability to manage multiple priorities under tight timelines, • Strong communication and collaboration skills, with experience working in cross-functional regulatory environments, • Willingness to travel to the Zug, Switzerland office quarterly or as needed Rewarding Those Who Make The Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. • Market leading compensation, • Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community, • We provide career development through regular feedback, continuous education and professional development programs, • We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Benefit Risk and Risk Management Lead Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Job Description Job Title: Benefit Risk and Risk Management Lead Employment Type: Contract About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Summary The Benefit Risk and Risk Management Lead is accountable for the global medical safety management of products and informs a robust understanding of the benefit-risk profile portfolio, assesses and reviews risk assessment/risk minimization activities, as well as additional pharmacovigilance activities, and if needed signal detection and evaluation to ensure products are safe for patients. Responsibilities: This leader will provide leadership and strategic insight and input into the following areas: • Lead, contribute to, and/or execute proactive safety surveillance and risk management activities, including product safety signal detection, evaluation, risk assessment, and risk minimization., • Contribute to benefit–risk assessments in partnership with other benefit–risk management functions., • Independently evaluate safety data from all sources, identify and analyze safety signals, and present medical assessments and benefit–risk evaluations to relevant committees and forums., • Develop independent action plans to address safety, risk, and benefit–risk issues, frequently coordinating cross-functionally to implement risk minimization strategies., • Review and approve safety documents, including those related to product benefit–risk profiles., • Ensure consistent safety and risk messaging for a product or product class across indications and business units., • Apply a strong understanding of aggregate safety data, signal detection methodologies, and benefit–risk assessment processes., • Conduct comprehensive safety data reviews, safety assessments, clinical safety signal identification, and risk identification and management., • Synthesize data to support informed benefit–risk decisions., • Demonstrate knowledge of global safety and regulatory issues relevant to clinical research and drug development., • Serve as the safety point of contact for Asset Teams and, when needed, chair appropriate Risk Management Committees., • Apply solid understanding of therapy mechanisms and drug-induced disease processes., • Lead cross-functional teams effectively, modeling commitment and enthusiasm in a matrixed environment with minimal oversight., • Exhibit strong scientific and medical expertise, including proficiency in interpreting medical literature., • Communicate clearly and effectively, both verbally and in writing., • Fulfill additional responsibilities as required by evolving project needs., • Work collaboratively within a matrix organization across multiple time zones. Candidate Profile • Medical Degree or equivalent, or a Healthcare professional, preferably with a postgraduate degree (Master’s, PhD or equivalent) in Pharmacy, Life Sciences, or a related discipline., • Minimum of 6 years of experience specifically in pharmacovigilance risk management., • Strong understanding of safety risk management principles and the relevant internal and external regulatory landscape, including applicable guidelines., • In-depth knowledge of pharmacovigilance regulations and requirements for the assigned geography., • Comprehensive understanding of the drug development process and post-marketing activities, with awareness of safety considerations throughout the product lifecycle., • Proven ability to influence and collaborate with internal and external stakeholders., • Ability to work independently while seeking guidance appropriately; recognizes and effectively leverages the expertise of colleagues to achieve team goals., • Demonstrated leadership, strong interpersonal skills, and experience working collaboratively in cross-functional environments., • High level of business ethics, integrity, and professionalism., • Strong communication skills with fluency in English., • Knowledge of good documentation practices, with strong attention to detail and accuracy., • Self-motivated, proactive, and able to work independently with a strong “can-do” attitude., • Global mindset, preferably with experience working in a multinational pharmaceutical organization., • Adaptable and resilient in a dynamic environment, with the ability to manage multiple projects simultaneously. Key Words: Risk Management, PV, Risk Management, Risk assessment

Job Description Oracle Health is developing patient-and provider-centric solutions rapidly and securely. We use the value of Oracle Cloud Infrastructure (OCI) to our customers as we work across patient, provider, payor, public, population health and life science industries. At OH (Oracle Health), you will work with authorities across industries and have access to the latest technology. We apply artificial intelligence, machine learning, large language models, learning networks, and other data intelligence and analytics in an applied way, embedded into our solutions. As a global leader we’re looking for a Senior Clinical Executive to drive success as part of our consulting team and work in a matrix environment with other industries and teams. Join us and create the future. What You Will Do Oracle Health is searching for a clinician to join us as a Senior Clinician Executive, becoming part of our clinical team. This is a strategic critical-safety role, guiding and supporting clients’ transformation initiatives and digital strategy. Clinician Executives are clinical knowledge and industry experts in Oracle, influencing the content and development of our digital platforms and understanding fast changing regulatory requirements and the evolving needs of healthcare organisations we look after. A Clinician Executive will deliver professional consulting services and is responsible for driving the implementation & adoption of Oracle digital solutions, helping customers transform the delivery of healthcare supported by technology. Clinician Executives facilitate and support large scale transformation programmes, benefits tracking, realisation, and quality & operational performance improvement initiatives. This is a high-level executive job in one of the world leading health IT companies, with exciting opportunities for professional development and engagement at a European and global level. The main job responsibilities will focus on relationship building and strategic alignment: Relationship Building: • Build trusted relationships with C-suite level client executives and key influencers in the health care industry, • Develop & maintain beneficial professional relationships with senior clinical leadership within Oracle’s client base, • Develop a deep understanding of Oracle products and capabilities and articulate how they can be applied by healthcare organisations to drive improved patient outcomes, • Consult with client and influence strategy, structure, management and operations through leadership and change management, • Drive increased client alignment and lead strategic clinical discussions with clients demonstrating benefits of clinical adoption and optimisation, • Drive value achievement through a client partnership that supports clinical, financial, and operational imperatives, • Lead referenceability of clients, designing strategies that directly impact client value proposition, • Act as an advisor in complex sales processes, providing expert solution demonstration support and answering requests for proposal (RFP) questions, • Generate ideas for the design and development of new solutions and services, • Represent Oracle through presentations and networking at key industry events., • Supporting our customers and Oracle with managing Clinical Risk Management requirements (e.g DCB0129/0160). Strategic Alignment: • Understand and articulate Oracle’s short and long term strategies, • Collaborate with client clinical and executive leadership to define strategy related to digital., • Serve as an expert consultative resource for process redesign and transformation, • Continuously strive to improve quality, safety, operations and the financial health of the organisation What We Will Offer You • A competitive salary with exciting benefits, • Flexible and remote working options so you can do your best work, • Learning and development opportunities to advance your career, • Employee resource groups that champion our diverse communities, • Core and flexible benefits, • An inclusive culture that celebrates what makes you unique Responsibilities Required Experience • Bachelors degree respective clinical expertise (Nursing, Pharmacy, Medicine, Health Care or related field) or equivalent relevant work experience, • Certification based on area of focus (Registered Nurse, Pharmacist, Licensed Medical Doctor etc), • Recent clinical experience in the last 3-5 years working in the UK community and/or mental health sector, • At least 6 years related work experience, including, at least 1 year of licensed health care practice, clinical consulting and/or other clinical healthcare information technology (HCIT) work experience Preferred Experience • Clinical background together with significant clinical leadership experience as a clinician, or equivalent experience in clinical informatics., • Evidence of post graduate learning in the community and/or mental health sector, • Deep understanding of community and/or mental health healthcare provision including delivery networks, community hospitals, academic and children's hospital systems & government entities, • Certified as an NHS Clinical Safety Officer, • Understanding and certification in methodologies such as Lean-Six Sigma., • An understanding of back-office solutions, such as ERP, HCM (etc) in a healthcare context, • Analytical skills including financial, process, and risk analysis, • Experience of successfully engaging with executive and clinical leaders in health & care, • Experience of automating workflow, process redesign and process improvement, • Experience leading and/or facilitating organizational and clinical change, • Strong understanding of healthcare strategy, operations and regulatory requirements Expectations • Willing to travel to client site as needed, • Willing to work additional or irregular hours as needed and allowed by local regulations Qualifications Career Level - IC3 About Us As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

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