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Freyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise. Job Title: Global Labeling Lead Location : Poland, UK , Romania, Hungary, Croatia, Czech Republic • Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation., • Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content., • Precedent Search and Labeling Trends - Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Client products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Client products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals., • Working within Labeling Team and GRA - Represents Global Labeling at Global Regulatory Team (GRT) - Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met., • Represents global labeling in departmental and cross-functional task-forces and initiatives., • Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes., • Vendor Management - Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards., • Continuous Improvement - Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy., • BSc degree, preferred; BA accepted., • Advanced scientific degree (MSc, PhD, or PharmD) preferred., • 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience., • Strategic Thinking - Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management., • Demonstrates an understanding of core business aspect., • Communication - Ability to effectively collaborate with global cross-functional teams., • Ability to use communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation formats., • Ability to promote regulatory decisions across global cross-functional teams. #J-18808-Ljbffr

Job Description:Salary Range: £44,171 - £55,000Leonardo UK operates a grade-based salary framework with broad bands. The salary range shown reflects the approved grade band for this role, or a narrower hiring range published within that band, and is benchmarked against the external market. Exceptions above the standard range are managed through governance controls to protect internal equity.Your ImpactAn exciting opportunity has arisen for a Risk Analyst to join the Risk Function Team and support the continued development and delivery of Leonardo's Enterprise Risk Management framework across the Electronics Division. This role offers an excellent opportunity for someone with existing risk and analytical experience to further develop their capability within a complex, highly regulated and strategically important environment.The role reports into the Enterprise Risk Manager and is to be based at Edinburgh, although we will consider other locations including Luton and Newcastle, with travel to other Leonardo UK sites and occasional travel to Italy as required.The successful candidate will work closely with Process and Risk Owners and functional teams to support the identification, assessment and management of both threats and opportunities across the business. The role will involve facilitating and supporting risk discussions and workshops, maintaining risk information within the corporate risk management system, and helping ensure mitigation actions are appropriately tracked and evidenced through to completion.A key aspect of the role is supporting the delivery of insightful risk reporting that enables informed decision making. We are looking for someone with strong analytical capability who can interpret data, identify trends, develop predictive analytics using AI and present information clearly for a range of stakeholders. Experience developing dashboards and reporting in Power BI would be highly advantageous, particularly the ability to translate complex information into visually engaging outputs.The role will also support quantitative risk analysis activity, including interpretation of Monte Carlo analysis and S-Curves. Candidates should therefore be comfortable working with data and able to apply a logical and structured approach to analysis and problem solving.Strong stakeholder engagement skills are essential. The successful candidate will need to communicate confidently with colleagues across all levels of the business, building effective working relationships and supporting the continued promotion of a positive and proactive risk culture across Leonardo.This position would suit someone who is organised, commercially aware and keen to continue building a career within enterprise risk management, while contributing to the ongoing maturity and effectiveness of risk management across the business.What You'll BringDeep understanding of Risk Management frameworks and corporate governance principlesPrevious experience within Enterprise Risk Management, Project Risk, or a related governance environmentExperience facilitating or supporting risk workshops, interviews, or risk review activitiesStrong analytical and problem-solving capabilityExperience using Power BI and/or advanced Excel to develop dashboards, reporting or data visualisations and familiarity with SQL, Python or Talend is highly advantageous.Strong communication and stakeholder engagement skills, including the ability to collaborate confidently with senior stakeholdersStrong organisational skills with the ability to manage competing priorities effectivelyHigh competency across Microsoft Office applicationsAbility to work collaboratively within a team environment while also operating independently when requiredRight to work in the UK and willingness to travel occasionally to other Leonardo sitesYou'll need to be eligible for SC clearance – while you don't need to have it yet, you should meet the requirements to obtain it (usually 5 years' continuous UK residency and the ability to pass background checks). We'll guide you through the process if you're successful.Additional experience as follows would be welcomed but is not essentialBachelors' or Master degree in Finance, Economics, Mathematics or similar STEM subject is beneficial or be working towards qualifications in Risk Management, Project Management, or related disciplinesPrevious experience within Aerospace, Defence, Engineering, Manufacturing or Technology sectorsExperience working within a large, complex, or highly regulated organisationKnowledge or experience of audit, assurance, or compliance-related processesExperience working with enterprise risk management systems or governance toolsExposure to Monte Carlo analysis, S-Curves, or quantitative risk analysis techniquesSecurity ClearanceThis role is subject to pre-employment screening in line with the UK Government's Baseline Personnel Security Standard (BPSS). An additional range of Personnel Security Controls referred to as National Security Vetting (NSV) may apply, this could include meeting the eligibility requirements for The Security Check (SC) or Developed Vetting (DV). For more information and guidance please visit: join usAt Leonardo, our people are at the heart of everything we do. We offer a comprehensive, company-funded benefits package that supports your wellbeing, career development, and work–life balance. Whether you're looking to grow professionally, care for your health, or plan for the future, we're here to help you thrive.Time to Recharge: Enjoy generous leave with the opportunity to accrue up to 12 additional flexi-days each year.Secure your Future: Benefit from our award-winning pension scheme with up to 15% employer contribution.Your Wellbeing Matters: Free access to mental health support, financial advice, and employee-led networks championing inclusion and diversity (Enable, Pride, Equalise, Armed Forces, Carers, Wellbeing and Ethnicity).Rewarding Performance : All employees at management level and below are eligible for our bonus scheme.Never Stop Learning : Free access to 4,000+ online courses via Coursera and LinkedIn Learning.Refer a friend: Receive a financial reward through our referral programme.Tailored Perks : Spend up to £500 annually on flexible benefits including private healthcare, dental, family cover, tech & lifestyle discounts, gym memberships and more.Flexible working: Flexible hours with hybrid working options. For part time opportunities, please talk to us about what might be possible for this role.For a full list of our company benefits please visit our website.Leonardo is a global leader in Aerospace, Defence, and Security. Headquartered in Italy, we employ over 53,000 people worldwide including 8,500 across 9 sites in the UK. Our employees are not just part of a team—they are key contributors to shaping innovation, advancing technology, and enhancing global safety.At Leonardo we are committed to building an inclusive, accessible, and welcoming workplace. We believe that a diverse workforce sparks creativity, drives innovation, and leads to better outcomes for our people and our customers. If you have any accessibility requirements to support you during the recruitment process, just let us know.Be part of something bigger - apply now!#LI-KA1#LI-hybridPrimary Location:GB - EdinburghAdditional Locations:GB - Luton - Cap. Green 300Contract Type:PermanentHybrid Working:HybridTPBN1_UKTJ

About Barhale Who are Barhale? Barhale is a business founded on family values, having been established by our Chairman, Dennis Curran, in 1980. We are one of the largest privately owned civil engineering and infrastructure specialists in the UK, with over 40 years of experience in providing design, civil engineering and maintenance services working across multiple sectors, including: • Water, • Transport, • Built environment, • Energy We operate as a tier one partner for blue chip, regulated and private clients, working as part of large frameworks, joint ventures and alliances, as well as on individual standalone projects, developing long-term relationships based on delivering to the Barhale values which have been integral to our business since their inception in 1985. Our direct delivery model is at the core of everything we do, as we believe that people are our greatest asset. Therefore, we robustly source, train and retain all our own frontline delivery teams as well as management and support services. We employ over 1,200 employees nationwide. We possess a range of specialist skills to support our civil engineering and infrastructure activities, including: • Tunnelling, • MEICA, • Temporary and permanent design, • Steel-fabrication, • Signs (design and fabrication), • Health & safety equipment and products, including PPE Why join Barhale? • As Gold Investors in People, we are committed to a high standard of people practices, creating an inclusive environment and ensuring cultural alignment to business strategy, ethos and philosophies., • Job security, long-term secured work through various frameworks and large infrastructure schemes, • A broad range of civil engineering, mechanical and electrical schemes across some of the UKs largest infrastructure projects and clients, • Strong career progression as demonstrated by our track record in promoting from within, as we believe this is a key driver of our success HSE Performance Coach The Role To coach and enhance a positive culture around Health, Safety and Environment with direct and in-directly employed workforce. Key Responsibilities • Coach and support teams in service avoidance best practices, including promoting safe excavation practices, utility detection techniques, permit controls, and compliance with HSG47 requirements, • Attend site to monitor and advise personnel on healthy and safe working practices, • Carry out training and toolbox talks as required or where a specific training need is identified, • Work with site managers to communicate method statements, safe working systems and risk assessments, • Discuss construction methods and occupational health, wellbeing and safety systems to determine level of awareness and encourage improvement ideas, • Attend site and regional health and safety committee meetings and report back where appropriate, • Communicate the importance of adhering to Health and Safety policies and procedures, and the near-miss procedure, • Liaise with the HSE Advisor to review inspection reports to monitor any outstanding actions, • Carry out follow-up inspections and visit sites to check on process reporting the progress to Managers, • Conduct relevant focused site inspections in line with Company and legislative requirements, • Promote Front Foot Safety Initiatives with the workforce, • Regularly promote the Barhale Take 5 principle of proactive safety culture by encouraging employees to stop and review tasks when uncertain or where safety concerns exist, and by raising awareness of risks faced by personnel working in areas deemed as dangerous also known as the Line of Fire within Barhale, • Support the delivery of the Be Health, Be Safe & Be Alert programme as directed by the HSE Advisor with the workforce, • Encourage the adoption of safety best practices identified across other sites, • Strengthen behavioural safety programme with workforce, • Regularly review all Health and Safety policies and procedures to ensure information is retained and make recommendations for improvement where appropriate, • Agree learning and development objectives with Regional Manager and Head of Training and take responsibility to ensure that appropriate training takes place, • Drive the identification and management of changing site conditions that may increase HSE risks, including changes to design scope, personnel, equipment, work methodologies, weather conditions, and workforce health, ensuring appropriate risk reviews and controls are implemented at gang level, including operative skin surveys, • Monitor operational workforce fatigue and raise awareness, • Raise musculoskeletal awareness with the workforce, • Support Occupational Health and Wellbeing initiatives, including respiratory health and noise-at-work programmes, through awareness campaigns, Toolbox Talks (TBTs), workplace assessments, and compliance monitoring, • Promote Health and Wellbeing near miss reporting, • Encourage the adoption of Occupational Health Good Practices from other sites, • Monitor compliance with environmental aspect and impact assessments, • Foster a culture of environmental responsibility among the workforce, • Check practical environmental compliance I.e. spill management, refuelling, spill response, over-pumping operations, desilting, waste control, • Increase awareness and participation in on-site recycling and reuse initiatives to reduce waste and improve environmental performance, • Drive energy reduction on site through the adoption of fuel-saving measures, energy-efficient working practices, and workforce-led improvement initiatives About you Essential • Previous experience working within Health, Safety and Environment (HSE) role, • Excellent communication and active listening skills, • Strong coaching and mentoring abilities, • Ability to influence and engage stakeholders at all levels, • Experience in service avoidance Desirable • Formal coaching qualification or experience, • Knowledge of the Companys core activities, including pipe-laying, tunnelling and shaft sinking, • CSCS card, • SMSTS, • Environmental Awareness Training (1/2 day), • 2-day service avoidance, • NRSWA Supervisor, • Manual handling, • Confined space high risk category Caring and investing in you Our values have been embedded at Barhale for over 40 years, and they are our guiding principles regarding how we care and invest in people. Our values are our commitment to being a people-centric company. As a Gold Investors in People company and a Sunday Times 100 Best Company to Work For, we are committed to investing in people. We are passionate about creating a working environment where people are supported throughout their careers, where people can enjoy security and be part of a company that cares about them. From the moment you join us, your well-being and career aspirations will be supported by. • Competitive salary, • Company Pension, • Life Assurance, • Private Medical, • 25 days of annual leave in addition to 8 public bank holidays and loyalty days, • 8 hours volunteering, • Employee Assistance Programme to support your mental, physiological and financial wellbeing, • Flexible benefits via salary sacrifice, • Company car/green car scheme/car allowance/Van (dependent on position), • Leadership & management training and coaching, • Regular line management engagement and appraisal to support your career progression, • Development supported by internal and externally delivered training, • Continuous service awards JBRP1_UKTJ

Legal Counsel Reporting to the Head of Legal & Data Protection (UK&I), this junior/mid level role will provide general legal support across the Randstad UK & Ireland business. The role will include both contentious and non-contentious matters, seeking to efficiently and cost-effectively deal with a high volume of work by prioritising based on the strategic needs of the business. Priorities for the role include: Client contracts: Lead negotiations on a range of simple client agreements, from amendments to Randstad standard terms to negotiation of the client's own terms Support senior members of the team with review and negotiation of more complex client agreements Assist with development and rollout of a contracting strategy, supporting with training initiatives as appropriate Sales: Support the sales team and Contract Manager with new bids, addressing legal risks in a sales-friendly manner Undertaking contract reviews and delivering 'ready to send' legal comments to minimise workload for the pursuit lead Supplier contracts: Review and negotiation of supplier contracts Support the Paralegal with supplier validation and compliance/audit checks Contentious matters: Working with Legal and Business Assurance colleagues on cost-effective resolution of complaints and disputes, including: Low-touch, cost-conscious management of pre-litigation matters Manage the outsourcing of more complex claims to external counsel Working with support staff to manage the outsourcing of debt enforcement matters to debt recovery specialists, reporting on progress to relevant internal stakeholders Support with training the business on dispute avoidance tactics, and with appropriate intervention strategies should common causes of disputes be identified Dealing with the application of employment and related financial regulation to our operationsCandidate profile: Qualifications: Qualified lawyer, admitted to practice in UK or ILEX Experience: Recruitment or other service industry experience is preferable but by no means essential Commercial contracts experience in a 'supplier' organisation desirable Basic dispute resolution Understanding of the contracting considerations related to outsourcing, procurement, and supply chain contracting RFP/sales support in competitive tender situations with limited opportunity to negotiate Understanding of the dynamics of working in a medium to large international companyIf you are interested in this position please apply now or get in touch with Sam Badger. At Randstad, we are committed to being an inclusive employer. We believe that our success is built on the unique backgrounds, experiences and identities of our people. We welcome applications from all sections of the community, regardless of age, disability, gender identity, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation. We want to ensure our recruitment process is accessible to everyone. If you require any reasonable adjustments to help you apply or to take part in the interview process, please let us know. Randstad is committed to equal opportunities for all and will not discriminate based on an individual's sex, race, disability, gender reassignment, pregnancy and maternity, marriage and civil partnership, religion or belief, sexual orientation or age. We are an inclusive employer and should you require any reasonable adjustments in order to complete any aspect of the recruitment process, please contact us on (url removed)

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