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Who we are \n \n For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. \n \n The role \n \n ProPharma is currently expanding its Compliance and Quality Assurance team with its newest Permanent auditor which can be based in any of our Eastern European hubs (remote based in Serbia, Croatia, Bulgaria or Bosnia). This is a newly created position within our organisation at its key focus will be to audit clients in Computer System Validation, AI Assurance & Data Integrity across the EMEA. \n \n Responsibilities \n\n • Conduct Audits of Pharmaceutical, medical device, clinical, and software development organizations for compliance with health authority regulations applicable to computer systems, artificial intelligence, data integrity\n, • Conduct gap assessments and provide remediation guidance for compliance with health authority regulations applicable to computer system, artificial intelligence, and data integrity\n, • Authoring policies, procedures, and work instructions compliance with health authority regulations applicable to computer system, artificial intelligence, and data integrity\n, • Provide clients with advice and guidance on computer system validation, AI compliance, and data integrity compliance approaches. Manage teams of internal resources in executing these strategies.\n, • Assist in developing and maintaining internal procedures and tools for delivery of CSV, AI assurance, and data integrity services.\n, • Develop and deliver original CSV content on current topics impacting the area of Computer System Validation, AI compliance, and electronic data integrity. Examples include blogs, training materials, webinars.\n, • Teach computer system validation, software/AI quality compliance, and data integrity classes, as needed.\n, • Participate in development of business strategies for growth of ProPharma’s CSV, AI Assurance, and Data Integrity practice.\n, • Assist in development of the Marketing and Sales materials.\n, • Assist in Business Development activities.\n, • Assist Operations in staffing client projects.\n, • Lead interviews of ProPharma Group candidates.\n, • Some travel required.\n, • Other duties as assigned.\n\n \n Required skills and experience \n\n • Educated to a BSc or higher within a life-sciences or related discipline to the role\n, • Certified auditor\n, • Minimum 10 years auditing experience. At least 30 audits in one or more of these areas: Computer System Validation (CSV), IT GxP compliance, AI GxP compliance, electronic data integrity.\n, • Minimum 15 years in Pharma/Med Device industry\n, • Fluent in English and ideally one other EU language\n, • Experience in the validation of all computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.\n, • Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem.\n, • Basic understanding of AI use cases and emerging GxP compliance requirements\n, • Experience in authoring policies and procedures (SOPs).\n, • Experience conducting audits and gap assessments.\n, • Experience managing internal personnel, contract resources, and projects.\n, • Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.\n, • Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents, such as those from ICH and PIC/S.\n, • Expert knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).\n, • Expert knowledge of Data Integrity guidance documents, such as those from the US FDA, EMA, MHRA, PIC/S, and WHO.\n, • Proficiency public speaking via in person and online forums.\n\n \n Additional Information \n We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. \n \n All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. \n \n Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. \n \n *ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*

Who we are For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The role ProPharma is currently expanding its Compliance and Quality Assurance team with its newest Permanent auditor which can be based in any of our Eastern European hubs (remote based in Serbia, Croatia, Bulgaria or Bosnia). This is a newly created position within our organisation at its key focus will be to audit clients in Computer System Validation, AI Assurance & Data Integrity across the EMEA. Responsibilities • Conduct Audits of Pharmaceutical, medical device, clinical, and software development organizations for compliance with health authority regulations applicable to computer systems, artificial intelligence, data integrity, • Conduct gap assessments and provide remediation guidance for compliance with health authority regulations applicable to computer system, artificial intelligence, and data integrity, • Authoring policies, procedures, and work instructions compliance with health authority regulations applicable to computer system, artificial intelligence, and data integrity, • Provide clients with advice and guidance on computer system validation, AI compliance, and data integrity compliance approaches. Manage teams of internal resources in executing these strategies., • Assist in developing and maintaining internal procedures and tools for delivery of CSV, AI assurance, and data integrity services., • Develop and deliver original CSV content on current topics impacting the area of Computer System Validation, AI compliance, and electronic data integrity. Examples include blogs, training materials, webinars., • Teach computer system validation, software/AI quality compliance, and data integrity classes, as needed., • Participate in development of business strategies for growth of ProPharma’s CSV, AI Assurance, and Data Integrity practice., • Assist in development of the Marketing and Sales materials., • Assist in Business Development activities., • Assist Operations in staffing client projects., • Lead interviews of ProPharma Group candidates., • Some travel required., • Other duties as assigned. Required skills and experience • Educated to a BSc or higher within a life-sciences or related discipline to the role, • Certified auditor, • Minimum 10 years auditing experience. At least 30 audits in one or more of these areas: Computer System Validation (CSV), IT GxP compliance, AI GxP compliance, electronic data integrity., • Minimum 15 years in Pharma/Med Device industry, • Fluent in English and ideally one other EU language, • Experience in the validation of all computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications., • Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem., • Basic understanding of AI use cases and emerging GxP compliance requirements, • Experience in authoring policies and procedures (SOPs)., • Experience conducting audits and gap assessments., • Experience managing internal personnel, contract resources, and projects., • Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents., • Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents, such as those from ICH and PIC/S., • Expert knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500)., • Expert knowledge of Data Integrity guidance documents, such as those from the US FDA, EMA, MHRA, PIC/S, and WHO., • Proficiency public speaking via in person and online forums. Additional Information We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. *ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*

We have an exciting opportunity for a Client Relationship Specialist (Private Capital) to join our Marketing team, based in A&O Shearman’s Belfast Office. Marketing team – Belfast Our business development, marketing and communication teams contribute to the setting and achievement of the firm's business objectives, which includes supporting our partners and associates in their pursuit of becoming our clients' trusted advisers, building and maintaining long-lasting, deep institutional client relationships, winning new clients, increasing the visibility of the firm globally, and positioning the firm as the thought leader and most advanced law firm among the global elite law firms. The function works as one team across the globe with very close collaboration between the central teams and professionals supporting offices, practice groups, sectors and clients. What you will do An integral member of the Client Relationship Management Team, the Specialist will support the Client Relationship Management Team, working with the relevant relationship Managers/Senior Managers, in managing the firm's private capital priority clients, and supporting ad-hoc on the strategic clients list, as well as getting involved in sector level projects. They will also play a key role in supporting and assisting with certain firm-wide initiatives, activities, campaigns and projects. Relationship Management Producing client-facing materials, including client relationship statements/reports, major proposals/panel pitches, client presentations and monthly / quarterly value-add reports. Preparing for and attending regular internal meetings with the Global Relationship Manager, Global Relationship Partners and other core team members to agree client targeting plans, monitor progress against objectives, identify opportunities and monitor financials. Producing client-related research and analysis including: client strategy, client structures, financials, key contact mapping, competitor activity, developments in the client's markets and relationship gap analysis (to help identify leads and opportunities). Continued commitment to learning about the Private Capital sector and our clients, including review of the press and distribution to relevant internal stakeholders. Coordinating specific client targeting initiatives, working closely with the client team and Business Development colleagues around the network. Organizing and running client specific events, entertainment and client training, including providing strategic support from inception to delivery. Providing support for content initiatives, including coordinating and tracking client outreach. Supporting with the management of secondments at priority clients, in conjunction with the relevant individual from Business Development, including pre-secondment briefings, regular catch-ups and post-secondment debriefs to gather intelligence and ensure we are seizing all opportunities with the client, and feeding insights back to the client relationship team. Developing and distributing internal communication for the global client team and within the firm (e.G. disseminating client-specific market intelligence, internal updates and newsletters and financial reports). This also includes working on bespoke financial reporting requested by clients and/or internal stakeholders. Collecting, co-ordinating and updating various client information globally. Various administrative tasks related to the sector, including matter tracking and contact tracking. Being involved in firm-wide and practice area projects relating to specific clients. Maintaining client information to ensure it is kept up-to-date (e.G. secondment trackers, activity trackers, client snapshot pages on the intranet, including ensuring that our marketing database, Dynamics, is kept up-to-date with relevant client content and activities.) Additional projects – Opportunity to assist in firm wide, local, departmental or practice area projects. Supporting wider team members in their day-to-day work, including working closely with marketing apprentices. What you will have Graduate (plus commitment to, or existing additional professional marketing/business qualifications). 3 years’ proven marketing experience. Experience in a professional services organisation or in the legal services sector would be a significant advantage. Knowledge of, and interest in, business and the economy. Good communication skills – both written and oral. Strong interpersonal and influencing skills – with partners, key associates, and business development colleagues, clients and suppliers. High attention to detail and a commitment to quality. A team player. Professional, proactive, creative, good humoured and enthusiastic approach to all work and interactions. Ability to work to deadlines, juggle multiple projects and deliver under pressure. Ability to plan ahead, anticipate one’s own workload and knowing how to work with busy fee earners, balancing conflicting priorities and does not over-commit to unrealistic deliverables – always manages expectations. Well organised. Ability to work independently with limited supervision. What we can offer you To learn more about the culture and benefits available at A&O Shearman, please visit: Culture and benefits | A&O Shearman careers Should you require additional support at any stage of the recruitment process due to a disability or a health condition, please do not hesitate to contact a member of our recruitment team who will work with you to provide any adjustments as required. We are an equal opportunities recruiter and do not discriminate on the basis of race, colour, sex, religion, sexual orientation, national origin, disability, or any other protected characteristic. NO AGENCIES PLEASE - A&O Shearman does not accept unsolicited CVs. For further information, please see our UK Recruitment Agency Policy and our commitment to direct sourcing here. LI

Who we are For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The role ProPharma is currently expanding its Compliance and Quality Assurance team with its newest Permanent auditor which can be based in any of our Eastern European hubs (remote based in Serbia, Croatia, Bulgaria or Bosnia). This is a newly created position within our organisation at its key focus will be to audit clients in Computer System Validation, AI Assurance & Data Integrity across the EMEA. Responsibilities Conduct Audits of Pharmaceutical, medical device, clinical, and software development organizations for compliance with health authority regulations applicable to computer systems, artificial intelligence, data integrityConduct gap assessments and provide remediation guidance for compliance with health authority regulations applicable to computer system, artificial intelligence, and data integrityAuthoring policies, procedures, and work instructions compliance with health authority regulations applicable to computer system, artificial intelligence, and data integrityProvide clients with advice and guidance on computer system validation, AI compliance, and data integrity compliance approaches. Manage teams of internal resources in executing these strategies.Assist in developing and maintaining internal procedures and tools for delivery of CSV, AI assurance, and data integrity services.Develop and deliver original CSV content on current topics impacting the area of Computer System Validation, AI compliance, and electronic data integrity. Examples include blogs, training materials, webinars.Teach computer system validation, software/AI quality compliance, and data integrity classes, as needed.Participate in development of business strategies for growth of ProPharma’s CSV, AI Assurance, and Data Integrity practice.Assist in development of the Marketing and Sales materials.Assist in Business Development activities.Assist Operations in staffing client projects.Lead interviews of ProPharma Group candidates.Some travel required.Other duties as assigned. Required skills and experienceEducated to a BSc or higher within a life-sciences or related discipline to the roleCertified auditorMinimum 10 years auditing experience. At least 30 audits in one or more of these areas: Computer System Validation (CSV), IT GxP compliance, AI GxP compliance, electronic data integrity.Minimum 15 years in Pharma/Med Device industryFluent in English and ideally one other EU languageExperience in the validation of all computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem.Basic understanding of AI use cases and emerging GxP compliance requirementsExperience in authoring policies and procedures (SOPs).Experience conducting audits and gap assessments.Experience managing internal personnel, contract resources, and projects.Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents, such as those from ICH and PIC/S.Expert knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).Expert knowledge of Data Integrity guidance documents, such as those from the US FDA, EMA, MHRA, PIC/S, and WHO.Proficiency public speaking via in person and online forums. Additional Information We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether youre successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.