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Job description Site Name: Philadelphia Walnut Street, Stevenage Posted Date: May The Interventional Study Scientist Medical Director will lead the scientific design of interventional clinical studies, medical governance, and interpretation of results within the Medical Affairs organization (non-regulatory label-directed programs) for assigned asset(s)/indication(s). This role will partner closely with the GML and GMT and is the single point accountability for translating the evidence strategy set by the GMT into appropriate interventional studies. The study designed is expected to fulfill a strategic objective of the clinical development and integrated evidence plan. This role is pivotal in shaping data generation strategies and ensuring clinical trials are conducted with the highest standards of quality, ethics, and efficiency. The successful candidate will have deep expertise in industry-sponsored clinical research, global medical affairs, commercial acumen, and cross-functional team leadership. They will oversee multiple projects independently and may be responsible for study development and implementation across an entire therapeutic area. Must possess Oncology or Specialty Medicine experience. Key Responsibilities: Strategic Leadership: Translating the strategic vision for the therapeutic area and asset set forth by the GMT into Medical Affairs interventional studies and aligning them with GSK's overarching goals. Lead the design of interventional medical affairs clinical trials from Phase I through Phase IV including integrated input from internal/external experts, thought leaders and patients. Ensure alignment of interventional study strategies with regulatory requirements and industry best practices. Ensure that study objectives are consistent with decision criteria in the clinical development plan and integrated evidence plan. Ensure appropriate incorporation of design of study into protocol. Present the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct. Scientific oversight for the study: Oversee benefit - riskofthe study. Ensure studyanalysisplanisalignedtoobjectivesoftheprotocoland accountable for the clinical interpretation of study data and results. Review clinical data and studyconduct to assure patientsafetyandscientificintegrity.Thiswouldincludeongoingreviewofprotocol deviations and implementation of remedial plans. Oversee medicalgovernanceforthe study including medical monitoring. Outputs for the study: Interpretation of study data to create the scientific content of Clinical Study Report (CSR). Preparation of study results for abstracts, posters and presentations for scientific meetings, congresses, external journal publications. Preparation of clinical content of regulatory documents and interaction with global regulatory authorities for the study (if needed). Provides input into and reviews other relevant study document including the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM). Provides scientific content for other study specific documentation (e.g. slides for site/monitor/investigator training). Collaborate with cross-functional teams to ensure seamless execution and delivery of clinical programs, in particular the clinical development operations and biostatistics teams, as well as third party vendors. Monitor and manage study progress, ensuring compliance with protocols, regulatory requirements, and GSK standards. Team Leadership: Foster a collaborative and innovative culture within the interventional studies team. Provide guidance and support for professional development and career growth of team members. Partner with the Study Delivery Lead and Project Manager (in Clinical Operations) to ensure optimal delivery of the study. Maintain close collaboration with various functions including drug safety, regulatory affairs, biostats, TAs (GMLs and GMT) in medical affairs and clinical trial operations at the study level. Regulatory and Compliance: Ensure that all interventional studies are conducted in accordance with GCP, and other relevant regulatory guidelines. Maintain oversight of all regulatory submissions and interactions related to interventional studies. Ensure robust quality control and assurance processes are in place for all clinical trials. Stakeholder Engagement: Serve as the primary point of contact for internal and external stakeholders regarding the study. Collaborate with key opinion leaders, investigators, and external partners to enhance study design and execution. Communicate study progress, challenges, and outcomes to senior leadership, the GML/GMT, and other relevant stakeholders. Innovation and Continuous Improvement: Identify and implement innovative approaches to improve the efficiency and effectiveness of interventional studies. Stay abreast of industry trends, emerging technologies, and new methodologies in clinical research. Promote a culture of continuous improvement within the interventional studies team. Basic Qualifications: Advanced degree in a relevant scientific discipline (MD, PhD, PharmD, or equivalent). Oncology or Specialty Medicine experience is required. 10 + years of experience in clinical research, with 5 + years in a leadership role overseeing interventional studies. Led at least three large-scale interventional clinical trials from design to execution with demonstrated impact. 5+ years of experience as a medical monitor, overseeing at least three interventional clinical trials in compliance with ICH-GCP, FDA, EMA, and other global regulatory requirements. Experience analyzing and synthesizing data from multiple sources to drive decision-making, demonstrated by at least three instances of data-driven recommendations impacting trial design or execution. 5+ years of experience leading cross-functional line or matrix teams at the study level, including managing direct reports or leading virtual teams. Evidence of strong leadership skills with at least three examples of cross-functional collaboration on setting direction, obtaining alignment, and engaging for results resulting in strategic outcomes. Leading the resolution of at least two significant trial challenges, such as protocol amendments, patient recruitment obstacles, or regulatory compliance issues, resulting in improved study timelines, data quality, or regulatory approvals as a measure of strategic think and problem-solving. Experience managing multiple priorities in a fast-paced environment, overseeing simultaneous management of at least three studies or strategic initiatives. Preferred Qualifications: Physicians and specialization in relevant therapeutic area preferred. Experience collaborating with regulatory authorities. Familiarity with innovative approaches in clinical trial execution. Exposure to working with key opinion leaders, investigators, and external partners. Experience in developing scientific content for publications and regulatory submissions. Understanding of digital tools and AI-driven methodologies for evidence generation. Prior experience with cross-functional teams in a pharmaceutical or biotech setting. The annual base salary for new hires in this position ranges from $170,250 to $283,750 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK . click apply for full job details

Job Purpose The Senior Business Development Director will be responsible for executing both strategic and tactical initiatives to establish and maintain long-term client relationships, ultimately driving new business opportunities and sustainable revenue growth. Leveraging deep expertise in product and business development, they proactively engage with clients to identify opportunities, foster strong partnerships, and contribute to overall business expansion. About Regulated Industry: RWS Regulated Industries is a highly specialized division of RWS, a world-leading provider of technology-enabled language, content, and intellectual property services. The Regulated Industries division is focused on developing translation and content management solutions tailored to address the complex regulatory environment in force with premium sectors such as Life Sciences and Healthcare (pharmaceuticals, medical devices, CROs, healthcare companies), Finance (banks, asset management companies, insurance providers, fintech) and Legal (law firms, audit companies). Job Overview Responsibilities: Identify and target pharmaceutical companies, medical device manufacturers, contract research organizations (CROs), and biotech firms needing regulatory-compliant localization services. Develop and implement sales strategies to secure high-value contracts for clinical trial translations, regulatory submissions, and multilingual labeling. Meet or exceed revenue targets by acquiring new clients and expanding services within existing accounts. Research and engage with localization managers, regulatory affairs teams, clinical operations leaders, and medical writers to understand their multilingual needs. Generate leads through networking at industry events and conferences. Leverage CRM data and industry reports to identify new business opportunities. Build and maintain long-term strategic relationships with key decision-makers. Act as a trusted advisor by educating clients on the importance of linguistic validation, medical translation accuracy, and regulatory compliance (ISO 17100, EMA, FDA, MDR, IVDR, HIPAA, GDPR). Ensure seamless client experience by aligning language services with clinical trial timelines, product launches, and global regulatory requirements. Monitor industry trends, regulatory updates, and localization requirements across FDA, EMA, PMDA, and CFDA. Analyze competitor offerings and position differentiated solutions such as AI-powered medical translation, linguistic validation, and structured content management. Provide market intelligence to shape pricing strategies, service enhancements, and go-to-market approaches. Develop and present tailored proposals, RFP responses Skills and Experiences: Experience in an outbound revenue, Senior Business Development role B2B Localisation / Traslation Technology sales Proven track record of meeting sales targets Ability to communicate software solutions and ideas in detail and at a high level Ability to cold call into an organization and identify key decision makers and influencers Self-motivated and able to appropriately set and pursue own goals in support of the organization's goals Organized, flexible and able to manage multiple opportunities simultaneously; pays attention to detail and able to report results in a concise format Able to plan, organize and follow job activities in accordance with their importance and respond appropriately to changes and interruptions Working knowledge of preferred, but not required Must be a skilled communicator with a dynamic and engaging phone presence who excels in questioning and listening to determine the prospect's needs Must be a fast learner who enjoys self-education Must be able to generate well written correspondence to targeted customers Focused, polite and persistent; he/she knows how to learn and derive strength Life at RWS RWS is a content solutions company, powered by technology and human expertise. We grow the value of ideas, data and content by making sure organizations are understood. Everywhere. Our proprietary technology, 45+ AI patents and human experts help organizations bring ideas to market faster, build deeper relationships across borders and cultures, and enter new markets with confidence - growing their business and connecting them to a world of opportunities. It's why over 80 of the world's top 100 brands trust RWS to drive innovation, inform decisions and shape brand experiences. With 60+ global locations, across five continents, our teams work with businesses across almost all industries. Innovating since 1958, RWS is headquartered in the UK and publicly listed on AIM, the London Stock Exchange regulated market (RWS.L). RWS Values We Partner, We Pioneer, We Progress- and we'llDelivertogether. For further information, please visit: RWS RWS embraces DEI and promotes equal opportunity, we are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. RWS is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at RWS are based on business needs, job requirements and individual qualifications, without regard to race, religion, nationality, ethnicity, sex, age, disability, or sexual orientation. RWS will not tolerate discrimination based on any of these characteristics Recruitment Agencies: RWS Holdings PLC does not accept agency resumes. Please do not forward any unsolicited resumes to any RWS employees. Any unsolicited resume received will be treated as the property of RWS and Terms & Conditions associated with the use of such resume will be considered null and void.

Job Purpose The Senior Business Development Director will be responsible for executing both strategic and tactical initiatives to establish and maintain long-term client relationships, ultimately driving new business opportunities and sustainable revenue growth. Leveraging deep expertise in product and business development, they proactively engage with clients to identify opportunities, foster strong partnerships, and contribute to overall business expansion. About Regulated Industry: RWS Regulated Industries is a highly specialized division of RWS, a world-leading provider of technology-enabled language, content, and intellectual property services. The Regulated Industries division is focused on developing translation and content management solutions tailored to address the complex regulatory environment in force with premium sectors such as Life Sciences and Healthcare (pharmaceuticals, medical devices, CROs, healthcare companies), Finance (banks, asset management companies, insurance providers, fintech) and Legal (law firms, audit companies). Job Overview Responsibilities: Identify and target pharmaceutical companies, medical device manufacturers, contract research organizations (CROs), and biotech firms needing regulatory-compliant localization services. Develop and implement sales strategies to secure high-value contracts for clinical trial translations, regulatory submissions, and multilingual labeling. Meet or exceed revenue targets by acquiring new clients and expanding services within existing accounts. Research and engage with localization managers, regulatory affairs teams, clinical operations leaders, and medical writers to understand their multilingual needs. Generate leads through networking at industry events and conferences. Leverage CRM data and industry reports to identify new business opportunities. Build and maintain long-term strategic relationships with key decision-makers. Act as a trusted advisor by educating clients on the importance of linguistic validation, medical translation accuracy, and regulatory compliance (ISO 17100, EMA, FDA, MDR, IVDR, HIPAA, GDPR). Ensure seamless client experience by aligning language services with clinical trial timelines, product launches, and global regulatory requirements. Monitor industry trends, regulatory updates, and localization requirements across FDA, EMA, PMDA, and CFDA. Analyze competitor offerings and position differentiated solutions such as AI-powered medical translation, linguistic validation, and structured content management. Provide market intelligence to shape pricing strategies, service enhancements, and go-to-market approaches. Develop and present tailored proposals, RFP responses Skills and Experiences: Experience in an outbound revenue, Senior Business Development role B2B Localisation / Traslation Technology sales Proven track record of meeting sales targets Ability to communicate software solutions and ideas in detail and at a high level Ability to cold call into an organization and identify key decision makers and influencers Self-motivated and able to appropriately set and pursue own goals in support of the organization's goals Organized, flexible and able to manage multiple opportunities simultaneously; pays attention to detail and able to report results in a concise format Able to plan, organize and follow job activities in accordance with their importance and respond appropriately to changes and interruptions Working knowledge of preferred, but not required Must be a skilled communicator with a dynamic and engaging phone presence who excels in questioning and listening to determine the prospect's needs Must be a fast learner who enjoys self-education Must be able to generate well written correspondence to targeted customers Focused, polite and persistent; he/she knows how to learn and derive strength Life at RWS RWS is a content solutions company, powered by technology and human expertise. We grow the value of ideas, data and content by making sure organizations are understood. Everywhere. Our proprietary technology, 45+ AI patents and human experts help organizations bring ideas to market faster, build deeper relationships across borders and cultures, and enter new markets with confidence - growing their business and connecting them to a world of opportunities. It's why over 80 of the world's top 100 brands trust RWS to drive innovation, inform decisions and shape brand experiences. With 60+ global locations, across five continents, our teams work with businesses across almost all industries. Innovating since 1958, RWS is headquartered in the UK and publicly listed on AIM, the London Stock Exchange regulated market (RWS.L). RWS Values We Partner, We Pioneer, We Progress- and we'llDelivertogether. For further information, please visit: RWS RWS embraces DEI and promotes equal opportunity, we are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. RWS is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at RWS are based on business needs, job requirements and individual qualifications, without regard to race, religion, nationality, ethnicity, sex, age, disability, or sexual orientation. RWS will not tolerate discrimination based on any of these characteristics Recruitment Agencies: RWS Holdings PLC does not accept agency resumes. Please do not forward any unsolicited resumes to any RWS employees. Any unsolicited resume received will be treated as the property of RWS and Terms & Conditions associated with the use of such resume will be considered null and void.

We're on a mission to make money work for everyone. We're waving goodbye to the complicated and confusing ways of traditional banking. With our hot coral cards and get-paid-early feature, combined with financial education on social media and our award winning customer service, we have a long history of creating magical moments for our customers! We're not about selling products - we want to solve problems and change lives through Monzo ️ As a Lead Product Manager in Operations, you will lead high-impact initiatives, to enhance Monzo's award-winning customer support. As a senior member of Monzo's product team, you'll be responsible for defining the strategy and setting a high bar for impact and execution, requiring complex stakeholder alignment and coordination across multiple cross-functional teams. You'll partner closely with directors in Product, Engineering, Data, and Design to help shape Monzo's product strategy for Customer Support and drive innovation within the team. We're now gearing up for our next phase of growth, from 10 million to 20 million customers. What you'll be working on: Our Mission: The Operations team is on a mission to deliver an effortless experience for everyone - helping Monzo deliver on its mission of making money work for everyone. We enable the efficient growth of the company creating and revising the operating model and systems that scale as Monzo grows, that give us repeatability and flexibility and allows us to safely diversify into new products and locations We obsess over customer service experience and good customer outcomes that add value to the business and helps us to improve customer loyalty as we grow We build lean, tech-led servicing experiences, first What you'll be working on: As a Lead Product Manager for our Ops team, you'll ensure that we continue to meet and exceed the needs and expectations of our customers, and drive continued customer growth and scalability. That means you'll: Create a product strategy for your area, balancing work to create long-term growth and engagement, and work to hit short-term targets. Collaborate with engineering, design, data, user research and marketing to identify and validate new opportunities. Lead the planning process and associated roadmap prioritisation ensuring alignment within the team and with wider business goals and objectives. Create delightful experiences that solve user needs and pain points. Work with cross-functional partners (engineering, design, data, user research and marketing) to ensure projects are delivered on time and as planned, as well as with legal, compliance and regulatory affairs where relevant Communicate effectively. You get people inspired by the product vision and you share the right context with the right people at the right time. You should apply if: You've shipped world-class products at a fast growing company. You have a track record of leading the development of market-leading value propositions that drive significant growth at scale. You're data-driven and commercial. You have a proven track record of making an impact through experimentation and optimisation. You can work effectively with a diverse range of people and working styles - spanning engineering, design, data, user research, marketing, legal and compliance - to get stuff done. You're able to motivate, energise and inspire people towards a common goal. You're passionate about building value for customers and not just achieving business results. You're intellectually honest about your work's performance, continually striving for improvement. You can systematically break down and solve complex problems. You're able to make good decisions in complex situations where there's often no "right answer". You have the urge and resilience to challenge the status quo and make things better, and are full of creative ideas for how to do so. You're a fast learner, humble and curious, and enjoy learning every day and sharing your knowledge and experience. You're excited by what we're doing at Monzo, especially the opportunity to help us scale and provide amazing customer experiences. The interview process: Our interview process involves 4 main stages: Initial Call with Hiring Manager Final Loop, consisting of x3 hour long interviews to assess Project Walkthrough, Case Study and Leadership. A final stage with a VP or CPO within the Product team Our average process takes around 5-6 weeks but we will always work around your availability. You will have the chance to speak to our recruitment team at various points during your process but if you do have any specific questions ahead of this please contact us on What's in it for you: ️ We can help you relocate to the UK We can sponsor visas. This role can be based in our London office, but we're open to distributed working within the UK (with ad hoc - at least monthly - meetings in London). We offer flexible working hours and trust you to work enough hours to do your job well, at times that suit you and your team. Learning budget of £1,000 a year for books, training courses and conferences And much more, see our full list of benefits here If you prefer to work part-time, we'll make this happen whenever we can - whether this is to help you meet other commitments or strike a great work-life balance. Equal opportunities for everyone Diversity and inclusion are a priority for us and we're making sure we have lots of support for all of our people to grow at Monzo. At Monzo, we're embracing diversity by fostering an inclusive environment for all people to do the best work of their lives with us. This is integral to our mission of making money work for everyone. You can read more in our blog , 2024 Diversity and Inclusion Report and 2024 Gender Pay Gap Report. We're an equal opportunity employer. All applicants will be considered for employment without attention to age, ethnicity, religion, sex, sexual orientation, gender identity, family or parental status, national origin, or veteran, neurodiversity or disability status. If you have a preferred name, please use it to apply. We don't need full or birth names at application stage Apply for this job indicates a required field First Name Last Name Email Phone Resume/CV Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Please describe your experience that highlights your product strategy, vision, execution and impact at a senior level? 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We want to create an equitable, engaged and innovative workplace which gives people from all backgrounds the support they need to thrive and grow. Making Monzo work for everyone starts right at the beginning of every Monzonaut's journey: when they apply to work here. This demographic survey will help us better understand the people who apply to work at Monzo. It'll help us see how different groups progress through our hiring process, and where we need to make improvements to be more inclusive. If you choose to fill it out, all of the information you give us is: Voluntary . And we've included a "prefer not to say" option for every question. It'd be helpful if you still fill out the survey even if you choose "prefer not to say" for every question, as it's useful for us to understand & record this. We won't know if you choose to fill this survey in or not. Anonymous to Monzo . We can't tie your responses to you and they won't make a difference to the outcome of your application. We'll only use grouped responses for equal opportunities monitoring in our hiring process. By filling out this survey, you agree that we can use your responses for the purposes we've mentioned above. You are not letting us know if we need to make any adjustments to the hiring process because of disability or neurodiversity - to do this please email us. How would you describe your gender identity? Select Do you identify as transgender? Select What's your sexual orientation? Select Do you identify as having a disability? Select Do you consider yourself to be neurodivergent? Select How would your describe your ethnicity? Select By checking this box, I consent to Monzo collecting, storing . click apply for full job details

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: People Leader All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for an Associate Director, Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing area. This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to North America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. Remote work options may be considered on a case-by-case basis and if approved by the Company. Are you ready to join our team? Then please read further! You will be responsible for: Leading compound/submission/indication/disease area writing teams independently. May have additional major responsibility with supervision. Cross-functional, cross-TA, or cross-J&J initiative/collaboration. Larger organizational responsibility (eg, manage a subset of TA). Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking. Leading program-level/submission writing teams independently. Directly leading or setting objectives for others on team projects and tasks. Guiding or training cross functional team members on processes, best practices; coach or mentor more junior writers. Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes. Leading cross functional/cross TA, cross J&J process improvement initiatives, or other large process working groups. Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences. If a lead writer for a program: Primary point of contact and champion for Medical Writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program. Able to function as a lead writer on any compound independently. Leading discussions in Medical Writing and cross functional meetings as appropriate. Interacting with senior cross functional colleagues and external partners to strengthen coordination between departments. Able to oversee the work of external contractors. As a people manager: Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. Ensures direct report's adherence to established policies, procedural documents, and templates Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions. Qualifications /Requirements: University/college degree in a scientific discipline is required. Masters or PhD preferred. At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required! If a people manager, at least 2 years of people management experience. Multiple therapeutic area experience preferred. Strong attention to detail. Strong oral and written communication skills. Fluent written and spoken English. Expert project management skills, expert project/process improvement leadership. Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills. Ability to delegate responsibility to junior writers. Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United Kingdom - Requisition Number: R-020783 Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-021380 United States (East Coast)- Requisition Number: R-021383 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. For United States applicants: The anticipated base pay range for this position is $137,000 to $235,750 (USD) The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k . Employees are eligible for the following time off benefits: - Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year - Holiday pay, including Floating Holidays - up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job Title: Director, Customer Risk Management Overview: We are currently looking for a Director, reporting to the Head of Customer Risk Management (CRM) for Europe. The role is based in London, U.K., or Waterloo, Belgium. Mastercard has over $70B credit exposure to its customers and other counterparties worldwide, making the CRM role a key part of its evolving and rapidly growing business model. The CRM team is a vital component of the broader Strategy & Operations organization, supporting and driving Mastercard's success. The strategic nature of this exposure requires engagement with senior management, Mastercard's sales and product organizations, as well as our customers. This role offers great opportunities for career growth within Mastercard. This position is on the first line of defense, with key responsibilities including: Developing CRM strategy and roadmaps for the assigned portfolio Customer credit analysis and underwriting Formulating risk mitigation strategies Creating risk management solutions for new products Engaging with regulators within the region Role: The primary responsibility is to ensure customer risk is appropriately identified, monitored, and managed according to Mastercard's policies, procedures, and risk appetite. Responsibilities include, but are not limited to: Owning all CRM-related matters for the assigned portfolio Performing customer credit risk underwriting and presenting analyses to senior management for approval Leading the development of risk mitigants with account managers and customers Designing and implementing innovative risk management approaches for diverse business models Leading cross-functional teams to develop new risk management solutions, including for emerging areas like crypto Influencing credit policy and standards; developing CRM procedures Building strong relationships with sales and product teams Conducting credit considerations during new customer onboarding Managing impacts of customer failures, including portfolio transfers and license terminations Performing portfolio reviews and risk screening using early warning indicators Reporting regional exposure and risks to senior management Partnering with CRM Center of Excellence for continuous exposure monitoring Collaborating with Regulatory Affairs to engage regional regulators Working with Treasury and Settlement Operations to improve processes All About You: Graduate degree in business or equivalent Experience in credit risk assessment, financial statement analysis, and management; banking sector knowledge and European payments regulation experience are strong pluses Commercial mindset balancing risk and reward Strong analytical, problem-solving, negotiation, and influencing skills Leadership ability to manage diverse, high-performing teams and cross-functional projects Resilience and decision-making skills in crisis situations Excellent written and verbal communication skills in English

Senior Manager, Global Regulatory Affairs, Precision Medicine United Kingdom - Cambridge Regulatory Regular Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Responsibilities As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory strategy and in compliance with the appropriate IVD regulations. You will need to work closely under the direction of the Precision Medicine Leadership, collaborate with the Biomarker diagnostics team and global/regional Regulatory liaisons, to support Precision Medicine global regulatory initiatives and offer guidance, as applicable. You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs, global registration, and market access. This role will operate on a hybrid 3 days a week on-site schedule in either Stockley Park or Cambridge. Responsibilities: Represent Regulatory Affairs Precision Medicine or Dx Regulatory in cross-functional teams involved in the application of biomarkers and IVDs in drug clinical programs. Support implementation of business aligned Precision Medicine regulatory strategies to support Gilead assets from early development through registration and beyond. Maintain current understanding of changing global IVD and Companion Diagnostics (CDx) regulations, assess impact on drug development & registration activities. Provide Dx regulatory input to ensure compliance of diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and EU IVDR). Support preparation and filing of IVD Performance Study applications, SRD & IDE applications, HA briefing books, clinical protocols, study reports, ICFs, Investigator Brochures, IND applications, CTAs, BLAs, NDAs, PMAs, and labeling documents for drug and diagnostic products, in collaboration with Gilead internal functions, IVD partners and CROs. Contributes to Dx Regulatory QMS process improvements related to investigational devices which may have a significant impact on business. Support training related to the IVD/CDx medical devices & broader Precision Medicine initiatives. Ensures compliance with established practices, policies, processes, and any applicable regulatory requirements. Basic Qualifications: Bachelor's Degree and extensive experience OR Masters' Degree and extensive experience Preferred Qualifications: PharmD/MS with relevant experience. BA/BS with relevant experience. Significant Regulatory, Quality, compliance or related experience supporting development of investigational IVD devices in a biopharma setting. Experience with immuno- and molecular diagnostics technologies. Experience leading cross-functional diagnostics teams. Experience with authoring procedures and implementing processes. Experience working in companion diagnostics projects is strongly preferred. Experience with global policy, IVD regulations (e.g., EU IVDR, 21 CFR Parts 820, 814, 812, 809, FDA's LDT Rule, CLIA), standards (e.g. ISO 13485, ISO 20916, ISO 15189) and applicable guidelines (e.g., MDCG, EMA, FDA, etc.) as these apply to diagnostic development and authorization/clearance/approval. In-depth knowledge of applicable IVD regulatory requirements, international standards and guidance in the context of drug clinical development - ensure compliance with IVDR, adherence to GCP, and alignment with Medical Device QMS operations. In-depth knowledge of relevant Health Authorities (HA), as evidenced by past effectiveness and success with HA interactions. In-depth knowledge of the CDx co-development process, including key functions involved at various stages of development. Strong analytical skills, attention-to-detail, and writing skills, as evidenced through accomplishments in past roles. Strong interpersonal and communication skills, with ability to rapidly understand and adapt to different team dynamics. Proven ability and flexibility to work successfully in a team-oriented, matrixed environment. Strong organizational and project management skills (familiarity with MS Office Suite, SharePoint, Smartsheet, Lucid chart and other PM tools) Ability to travel, as needed. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R

Head of Government Affairs UK page is loaded Head of Government Affairs UK Apply remote type Hybrid locations London - The Shard time type Full time posted on Posted 6 Days Ago job requisition id R-93289 Job Description We have an excellent opportunity available for an experienced Head of Government Affairs to make a difference at Kraft Heinz. You will shape the external policy environment to support our commercial goals, drive sustainable business practices, and foster our reputation as a responsible food manufacturer. You will be responsible for building a new government affairs (GA) ecosystem to position Kraft Heinz as a thought and knowledge partner with government. Working closely with the Managing Director for the UK & Ireland, you will ensure that the organisation has a strong voice in public policy discussions and contributes to shaping legislation or regulatory frameworks relevant to our business. This is a meaningful role at the intersection of policy, business, and brand. This role lies within the European Developed Markets business unit. The position is based in London, located in the Shard, and will report to the Director for Government Affairs Europe, based in Brussels. Owning the development and execution of Kraft Heinz's GA and public affairs strategy in the UK will be your primary responsibility. You'll be working in a high performing team, alongside peers always trying to reach the next level! What you'll do Develop a long-term UK GA strategy and serve as an outstanding strategist and tactician in terms of planning and delivery. Guide the UKI Managing Director in engagement with senior political and industry leaders. Advise senior leadership and commercial teams on potential risks and opportunities arising from the policy landscape. With our agency partner, supervise and assess policy and regulatory developments affecting the food sector, including nutrition policy, packaging and sustainability, economic policy and trade. Build and maintain relationships with key collaborators across Westminster, devolved governments, local authorities, regulatory and institutional bodies (e.g., DEFRA, DBT), and relevant industry associations (e.g. IGD). Develop and deliver briefings, position papers, consultation responses, and public submissions on key legislative or regulatory proposals. Lead external messaging on policy, corporate announcements, and key business initiatives. Represent Kraft Heinz at external meetings, roundtables, parliamentary receptions, and industry forums. Support engagement with NGOs, think tanks, and advocacy groups on shared policy objectives (e.g., food reformulation, carbon reduction). Collaborate closely with internal teams across Legal, Regulatory, Sustainability, Procurement, R&D, and Communications to ensure alignment on public affairs activity. Mentor and leverage internal experts in government engagement. What you'll need: Guideline minimum of 10-years' experience in a public affairs, government relations, or policy role, ideally within a large FMCG or highly regulated sector. A strong understanding of the UK political and policy-making landscape coupled with a strong network. Specific knowledge of food, health, and sustainability policy is a plus. Self-starter with the ability to work independently and proactively in a fast-paced environment that requires management of multiple projects simultaneously. Familiarity with devolved government policy environments and experience with international and UK-EU trade challenges. Excellent written and verbal communication skills with the ability to engage and influence at all levels. Desired skills & attitude: Ability to speak fluently in lay terms to a range of audiences about the business and priorities and challenges of Kraft Heinz. Capability to make nuanced recommendations and business decisions based on facts and the work environment of Kraft Heinz. Comfortable with ambiguity, both internally and externally, using strong communication and problem-solving skills. Public affairs campaign skills, including involving traditional and social media. A relevant degree or equivalent experience (e.g., Politics, Public Policy, Law, Communications, or Food Science). What we offer you We are an ambitious employer with an industry-recognised career development pathway We have a meritocratic, pay for performance approach Flexible and hybrid working approach, including ability to work from abroad Inclusive culture/work environment, backed by leadership-sponsored Business Resource Groups Family-friendly; market leading parental leave benefits & sponsored nursery scheme Wellbeing Private medical cover & Digital GP Best-in-class gym discounts & cycle to work scheme Premium membership to Calm App 3 volunteering days per year (e.g. Soup Kitchen, Magic Breakfast) Location(s) London - The Shard Kraft Heinz is an Equal Opportunity Employer - Underrepresented Ethnic Minority Groups/Women/Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity and other protected classes. ABOUT US Kraft Heinz is a global food company with a delicious heritage.With iconic and emerging food and beverage brands around the world, we deliver the best taste, fun and quality to every meal table we touch. We're on a mission to disrupt not only our own business, but the global food industry. A consumer obsession and unexpected partnerships fuel our progress as we drive innovation across every part of our company. Around the world, our people are connected by a culture of ownership, agility and endless curiosity. We also believe in being good humans, who are working to improve our company, communities, and planet.We're proud of where we've been - and even more thrilled about where we're headed - as we nourish the world and lead the future of food. WHY US We grow our people to grow our business. We champion great people who bring ambition, curiosity, and high performance to the table as the guardians of our beloved and nostalgic brands. Good isn't good enough.We choose greatness every day by challenging the ordinary and making bold decisions. All while celebrating our wins - and our failures - as we work together to lead the future of food. Challenging the status quo takes talent.We invest in your purpose and potential by developing skills and nurturing strengths that leave a legacy on our business and a lasting impact on your career. Because great people make great companies, and we're growing something great here at Kraft Heinz. INCLUSION MATTERS TO US Everyone is welcome at our table. In fact, we thrive on learning and growing from our diverse backgrounds and perspectives. Doesn't matter who you are, where you're from, or who makes your heart sing. We want you to show up as your authentic self, excited to work with amazing colleagues to solve complex challenges and innovate in an ever-changing industry. We're committed to: Hiring and growing talent from diverse backgrounds and perspectives. Growing our Business Resource Groups - vibrant, celebrated communities that enhance our business through thought leadership employee engagement and professional development opportunities. Providing our managers and leaders high quality learning experiences to explore how to foster inclusion and belonging.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry , committed to making a positive impact on its customers, employees, and communities. The Role We are looking for an experienced consultant with deep expertise in navigating customers through complex software implementation. Veeva's Vault RIM suite is the industry's only unified software solution that provides fully integrated regulatory information management (RIM) capabilities, including data and document management, submission publishing, and archival on a single cloud-based platform. Veeva Systems is looking for consulting leaders with system implementation experience and a passion for helping customers optimize their regulatory data and document management processes. As a key member of our Professional Services team, the Senior Consultant will be responsible for understanding our customers' global regulatory needs, translating requirements into solution design, and defining global strategies for deploying our cloud-based solution for managing regulatory information across the enterprise. There is no work location requirement (remote position) within the EU/UK if a candidate is in close proximity to an airport and able to meet travel requirements. Qualified EU/UK based candidates are encouraged to apply. What You'll Do Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs Lead the solution design for implementation and use of the Vault Regulatory suite (Veeva Registrations, Veeva Submissions, Veeva Submissions Archive, Veeva Publishing) Lead configuration requirements workshops, design, prototype, configure, and document content solutions Program and project management, including resource planning, leading and motivating a cross-functional team Primary customer liaison managing communication between the project team, customer, and internal stakeholders Mentor project team and consultants, helping others improve their consulting skills Requirements 8+ years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant, business or IT representative In-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing and/or Viewing systems Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction Influential; experience leading teams through hard decisions and negotiating compromises Technical abilities and willingness to "roll up your sleeves" to design and implement a RIM solution Expert on life sciences compliance and computer systems validation requirements Ability to work independently in a fast-paced environment Ability to travel as required by the business Nice to Have Direct experience with systems such as Veeva Vault, PAREXEL/ LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc. Consulting experience, working with a major system integrator or software vendor Regulatory Affairs, Regulatory Operations or Pharmacovigilance background Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data and content PMP certification Execution experience with Agile methodology and/or ACP Certification Life Science, computer science, or related degree SaaS/Cloud experience Fluency in one or more of the following languages: German, French, Spanish, Italian Veeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. As an equal opportunity employer, Veeva is committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. It comes in many forms. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability and life experience shape us all into unique individuals. We value people for the individuals they are and the contributions they can bring to our teams. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at .

Can't find the right opportunity? Send us your CV and we'll be in touch Our vision is to create a safe and sustainable world Ricardo plc is a global strategic, environmental, and engineering consulting company. With over 100 years of engineering excellence and employing close to 3,000 employees in more than 20 countries, we provide exceptional levels of expertise in delivering leading-edge and innovative cross-sector sustainable products and solutions. Every day, we enable our customers to solve the most complex and dynamic challenges to help achieve a safe and sustainable world. We are looking to recruita Senior Consultant - SDS Author to be part of our team. Key Responsibilities: The Senior Consultant - SDS Author will be responsible for: Undertaking a range of Safety Data Sheet authoring for a variety of clients, with wider support to other technical areas including REACH, Poison Centre notifications etc. Providing extensive technical knowledge especially in the area of SDS authoring, undertaking authoring work using Ricardo's 3rd party SDS authoring software. Providing management of project staff related to customers / consultants working on technical projects as agreed with the Product Managers for specific customer work (Managing the quality, accuracy and timeliness of deliverables) Supporting the personal development of other members of the team across these technical areas and management skills. Reviewing SDS Authored by the team providing feedback, then working with them to improve the quality of deliverables, both directly and through procedural changes. Providing expert technical consultancy input to support the growth and development and evolution of our SDS Authoring Services, developing new consultancy solutions to emerging regulatory changes. Liaising with marketing and sales staff to ensure effective promotion of Ricardo's capabilities in support of sales activities to grow these areas. Identifying and helping to take forward opportunities that are uncovered through the technical work e.g. through technical conversations around Safety Data Sheets uncovering where the customer may require additional support in REACH, Poison Centres and Emergency Response or training opportunities and working with the sales team to close these. Key competencies and experience: Competent SDS author experience in across multiple jurisdictions (USA, EU, UK, Japan, China, Korea etc.), including extended-SDS. Have an extensive background in supply regulations (and potentially transport regs as well); safety data sheet authoring, understanding how to classify both substances and mixtures and author a fully compliant safety data sheet, expert knowledge of REACH and knowledge of Poison centres desirable but not a necessity. Performing and managing high quality technical consultancy in the field of chemical regulatory affairs. Have and maintain expert knowledge of the regulations affecting the worldwide chemical industry, in particular supply regulations GHS and CLP. Keep up to date with market trends and developments and provide technical support to colleagues in the development of new service offerings and creation of technical papers. Contribute ideas to the development of business strategy with respect to regulatory consultancy. Provide the product managers with management support to enable successful delivery of regulatory consultancy projects and fulfilment of personal development/ training needs for others in the team. Be an excellent communicator and used to presenting your ideas and project outputs to customers and ideally at regulatory conferences. Have the ability to manage and influence people effectively and/ or delegate work to others. Working here You will be warmly welcomed into our workplace where every voice matters. We are diverse thinkers and doers, coming together to create a culture of inclusion. We will support you to find your place. We will encourage you to use your passion and expertise to make a positive impact through the projects you work on. Your knowledge and desire to bring about change will be invaluable in helping deliver innovative solutions that support communities across the globe in becoming safer and more sustainable. Work life balance We offer flexible approaches to work, whether that is working from home, being in the office, or as a hybrid worker. We're happy to discuss flexible working arrangements. Wellbeing is at the core to our culture, allowing employees to flourish and to achieve their full potential. Diversity, Equality and Inclusion statement We are an Equal Opportunity Employer, we believe in each person's potential, and we'll help you reach yours. We have an ambitious diversity, equality, and inclusion approach as explained here. We value diversity; recognising that a more diverse workforce creates a richer and more varied working environment. Diversity also drives innovation, by allowing us to offer our clients the best consultancy service that we can. As part of our commitment to engage positively and pro-actively with all our employees to ensure an inclusive culture, we are a recognised as a 'disability confident' employer. Benefits We want you to know how much you are valued. Your remuneration and benefits package will reflect that. You will receive a range of benefits which include support for your physical and mental health. Next steps Once you have submitted your application a member of our Recruitment Team will be in touch. Please be aware that the timing can vary dependent on the volume of applications that we receive for each role and in some cases, we may start to review applications prior to the closing date. Ricardo is a Disability confident employer please advise the recruitment team via if you require any adjustments to support you throughout the recruitment process.

Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) Job ID REQ- United Kingdom Summary (3 days per week on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Senior Global Program Regulatory Manager We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team.The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle. About the Role Major accountabilities: Lead the implementation of regulatory strategies and operational activities across major global regions. Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents. Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams. Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials. Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans). Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals. Develop and implement strategies to minimize review delays and regulatory clock stops. Ensure timely and compliant responses to HA queries and requests. Contribute to departmental goal setting and lead initiatives to improve regulatory processes. Ensure adherence to internal policies, SOPs, and global regulatory requirements. Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Significant experience in regulatory affairs within the pharmaceutical industry. Proven track record in project management and regulatory operations. Experience representing the organization in cross-functional and cross-cultural settings. Strong knowledge of clinical trials, drug development, and regulatory compliance. Excellent problem-solving, negotiation, and communication skills. Detail-oriented with the ability to manage complex regulatory projects. Skilled in risk management and working with cross-functional teams. Ability to navigate and influence Health Authority interactions. Fluency in English (written and spoken) is essential. Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Job ID REQ- Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) Manage Consent Preferences Always Active If you provided your email for marketing or disease awareness purposes, you may need to provide further information to enable us to fully honor your preferences. Click here to learn more.

-Understand complex and critical business problems, formulates integrated analytical approach to mine data sources, employ statistical methods and machine learning algorithms to contribute solving unmet medical needs, discover actionable insights and automate process for reducing effort and time for repeated use. To manage the implementation and adherence to the overall data lifecycle of enterprise data from data acquisition or creation through enrichment, consumption, retention, and retirement, enabling the availability of useful, clean, and accurate data throughout its useful lifecycle. High agility to be able to work across various business domains. Integrate business presentations, smart visualization tools and contextual storytelling to translate findings back to business users with a clear impact. Independently manage budget, ensuring appropriate staffing and coordinating projects within the area. If managing a team: empowers the team and provides guidance and coaching, with initial guidance from more senior leaders supervised. This is usually their first people manager experience. About the Role Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The Role As a Senior Principal Data Scientist in the Medical Affairs Advanced Quantitative Sciences group, you will be responsible for the discussion and implementation of data science methodologies applied to patient-level data (including various clinical, real-world, and biomarker data) across clinical development. You will combine your data science and AI skills and your scientific knowledge in biology or medicine to enrich drug development decisions in close collaboration with internal and external partners. This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office. Key Accountabilities: You will contribute to planning, execution, interpretation, validation and communication of innovative exploratory analyses and algorithms, to facilitate internal decision making. You will provide technical expertise in data science and (predictive) machine learning/AI to identify opportunities for influencing internal decision making as well as discussions on white papers/regulatory policy. You will perform hands-on analysis of integrated data from clinical trials and the real world to generate fit-for-purpose evidence that is applied to decision making in drug development programs. Your Experience Ph.D. in data science, biostatistics, or other quantitative field (or equivalent). More than 3 years experience in clinical drug development with extensive exposure to clinical trials. Strong knowledge and understanding of statistical methods such as time to event analysis, machine learning, meta-analysis, mixed effect modeling, longitudinal modeling, Bayesian methods, variable selection methods (e.g., lasso, elastic net, random forest), design of clinical trials. Strong programming skills in R and Python. Demonstrated knowledge of data visualization, exploratory analysis, and predictive modeling. Excellent interpersonal and communication skills (verbal and writing). Ability to develop and deliver clear and concise presentations for both internal and external meetings in key decision-making situations. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

You will be a part of the Quality Assurance team and report to the Manager, Quality Assurance (Design). You will be responsible for applying in-depth knowledge, experience, expertise in multiple areas of medical device quality assurance, guiding the Quality Assurance design organisation in key Design Control activities, and collaborating cross-functionally with internal and external business partners on new product development and strategic initiatives to drive project results. If you thrive in a fast paced, multifunctional role and want to work to build a world-class Quality Assurance organization, read on. In this role, you will have the opportunity to: Serve as Quality Assurance lead for Design Control covering business-critical new product development projects and external partnership programs, including ensuring that state-of-the-art requirements are maintained throughout the product lifecycle. Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, Regulatory Affairs, Research and Development, Product and Program Management) to achieve project goals and meet timelines. Critically review and approve analytical and clinical study protocols and reports to assess quality, identify gaps, and provide mitigations that support successful new product development, bringing high-quality product to market. Define regulatory strategy and plans for clearance / approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD, and Companion Diagnostics markets, including providing input into 510(k), PMA and companion diagnostic submissions and acting on regulatory intelligence changes to ensure minimal impact to current and future portfolio. Mentor and coach LBS Quality Assurance professionals in their development and support building team capabilities. The essential requirements of the job include: Extensive experience in medical device industry covering Innovation and Design Control. Proven experience supporting submissions for high-complexity diagnostic products in a global market, specifically 510(k) and PMA submissions in the USA. Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, and the MDSAP programme. Substantial experience in commercial product development including transfer of complex feasibility projects into product commercialization. Experience in support of New Product Development for high complexity products with experience supporting complex clinical trials and Pharma partner integration. It would be a plus if you also possess previous experience in: The IVD, Companion Diagnostics, and/or stand-alone software/digital fields. Collaborating with external stakeholders, such as suppliers, and academia. FDA and EU requirements covering Design Control activities for IVDs and/or medical devices. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.