Regulatory Affairs Manager Location: London St Pancras Competitive salary, bonus & benefits Join our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product responsibilities, manage the regulatory process, and negotiate with regulatory agencies to provide rapid approvals with competitive labelling. Accountabilities: As a Regulatory Affairs Manager, you will: Identify regulatory strategies to support commercial and business objectives and company efficiencies. Plan and execute workload for the defined product responsibilities and agreeing plan with Regulatory Affairs Lead. Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling. Prepare high quality regulatory applications and regulatory responses for UK (including inputting into summary documents and responses for European applications). Provide regulatory input to commercial, medical affairs, market access, medical information, patient safety and supply chain functions. Ensure timely submission and approvals of licence applications and maintenance activities and compliance with UK regulatory requirements. Assure appropriate standards and policies for all technical aspects of the company’s activities in Regulatory Affairs are adhered to. Provide regulatory input/solutions to supply and stock issues. Liaise with Operations to manage pack changes and ensure labelling compliance. Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence. Provide strategic regulatory input relating to AZ promoted and cornerstone brands, including competitor intelligence. Project manage and deliver projects of commercial strategic value. Understand and promote UK business needs into European strategies on drug development and regulatory filings/issues. Ensure appropriate cross-functional input into the delivery of optimal licence strategies. Keep up-to-date with developments in the Regulatory environment and share this knowledge across the department and beyond, in the business interest. Ensure optimal departmental processes through continuous review. Actively contribute to the development, coaching and training of the department, including new starters. Proactively manage the regulatory process for clinical trials for UK. Essential Skills/Experience: Life Sciences Degree or appropriate professional qualifications. Significant experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company. Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role. Desired Skills/Experience: Therapy Area Expertise in Respiratory & Immunology. Experience in creating and delivering regulatory strategies. Postgraduate qualification. Are you ready to fuel your ambition and break new ground? Join us in turning our productive pipeline into a reality to impact patients' lives! Apply today! #J-18808-Ljbffr
Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. QUALIFICATIONS University degree from reputable universities (Preferably from Pharmacy, Chemistry, Chemical Engineering, Biology departments) Advanced command of written and spoken English Preferably regulatory work experience in a pharmaceutical company: Min 1 year of Regulatory Affairs experience for Specialist position Min 4 years of Regulatory Affairs experience for Executive position Advanced knowledge in MS Office applications High interpersonal, communication and presentation skills Good at teamwork Good at follow-up and strong planning skills No restriction for travel No military obligation for male candidates JOB DESCRIPTION Preparation of registration and variation files according to current Ministry of Health requirements Approval of registrations and sales permissions Preparation of SmPC/PIL submissions Manage the written correspondence with Ministry of Health before and after registration approval Follow up global and local regulatory requirements Maintain and update global and local regulatory systems Date Posted: 23-Şub-2024 Closing Date: Global Career Level: D AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
Immunology Business Partner - Alex Do you have expertise in, and passion for, Sales? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. BUSINESS AREA Get to directly impact the lives of patients by turning our deep and broad pipeline into a reality. Here patients always come first – we address unmet needs, from nephrology to immunology, and provide patient care along the entire journey. Have the opportunity to be involved in the next big thing, whilst making a meaningful difference to patients and wider society. What you’ll do Engage healthcare professionals in dialogue about approved indications and product efficacy/safety profiles to support on-label prescribing for appropriate patients. Find innovative solutions for drug accessibility to patients. Responsible for right positioning of the testing for treatment paradigm. Responsible for different accounts mapping with engagement plan to different stakeholders. Fill the gaps in patients' journey. Ensure right positioning of the drug and right use throughout scientific message and engagement plans. Follow up with all the stakeholders in the assigned accounts (Payers, Diagnostics, Purchasers & Pharmacists). Focus on all the cases to ensure proper diagnostics to establish testing concept. Achieve sales target and assigned Sales KPIs in line with our policies and procedures. Promote AstraZeneca’s portfolio and services by providing the latest and most relevant data and information to the right customer at the right time. Support Healthcare professionals’ decision and optimize patient outcomes in an ethical way. Leverage all available data sources to create, dynamically prioritize and adapt relevant territory and customer engagement plans. Demonstrate advanced customer engagement skills to deliver high quality customer interactions and maximize customer experience for the benefit of patients. Maintain a deep and current knowledge of the industry, trade association, competitors, buyer dynamics and focus effort on customer opportunities. Build interpersonal inclusion through self-awareness, developing curiosity, active listening and strengthening team/peer inclusion. Essential for the role AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We adhere to all applicable laws and regulations on inclusivity in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Applicants should possess the following qualifications to go through initial screening: Pharmacy or Medicine graduate. 2 Years Multinational Experience. Immunology/Biologics/Rheumatology Experience is a must. Alex Residency, and the role will be managing Alex & Delta 1 . Excellent communication skills in English/ Arabic. Presentation skills, digital abilities and learning agility. Experience with strategic accounts & KOL management. Effective interpersonal and team building skills. Completed military or other governmental obligations. Driving license is required. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. #J-18808-Ljbffr
Job Title - Lead Consultant - Service Asset & Configuration Management Career Level - E Leverage technology to impact patients and ultimately save lives. Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life-changing medicines? If so, AstraZeneca might be the one for you! ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. ABOUT OUR IT TEAM It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross-functionally and broadly together. About the role The SACM Solutions Engineer will be responsible for the design, development, implementation, and support of AstraZeneca Information Services solutions. This will involve all aspects of planning, analysis, design, development, testing, and implementation of solutions, and may involve working closely with third-party suppliers. The role will also be involved in providing recommendations on enhancements, monitoring the performance, and support maintenance of deployed solutions. The Solutions Engineer will adhere to the established AstraZeneca lifecycle methodology and practices and will be familiar with applications/infrastructure that their solutions will impact. THIS IS WHAT YOU’LL DO This role will provide solutions engineering services in support of the SACM function accountabilities including: Configuration Management: Develop and implement effective configuration management tools, processes, procedures, and governance. Design solutions for establishing and maintaining a Configuration Management Database (CMDB) accurately & record, track all configuration items (CIs) and their relationships on SNOW. Data quality, data certification, management information reporting layer. Data integration between SNOW and various CIs. Software Asset Management: Design software management workflows. Engineer SNOW architecture and design including interface setup for Software asset management lifecycle. Design solutions extensively on SAM PRO and Flexera to establish/manage the software asset lifecycle of a large-scale IT estate. Set up standards for compliance with licensing agreements and track software usage. Hardware Asset Management: Design solutions for configuration management of hardware assets. YOU WILL NEED TO HAVE Experience: Essential Prior experience with SAM PRO and Flexera to establish/manage the software asset lifecycle. Good expertise in recent versions of ServiceNow implementation and integration. Proven experience of managing relationships with third-party suppliers. Minimum 5 years of demonstrable experience in the areas below: Quality and compliance environment and application of policies, procedures, and guidelines. Evidence of designing, shaping, and implementing innovative infrastructure solutions and driving any changes. Hands-on experience in Enterprise Management, Monitoring, and Asset Management Tooling. Collaboration and Communication: Work closely with IT teams, vendors, and other stakeholders to gather and update information on configuration items. Communicate with relevant teams to ensure awareness of configuration management processes and compliance requirements. Continuous Improvement: Identify opportunities for process improvements and automation to enhance the efficiency of configuration management. Stay informed about industry best practices and emerging technologies related to configuration management. Desirable Well versed in ITIL V4.0 practices and processes. Skills and Capabilities Essential Good communication skills supporting joint working with geographically remote colleagues. Ability to interpret and communicate technical information into business language. Proven track record of designing, engineering, and implementing observability platforms, leveraging Enterprise Management, Monitoring & Security Tooling. Proven, excellent industry experience and ability to interact effectively and lead technology roadmaps with third parties. Desirable Good commercial awareness and understanding of the external market. Demonstrate initiative, strong customer orientation, and cross-cultural working. WHY JOIN US? We’re a network of high-reaching self-starters who supply to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions. We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters. SO, WHAT’S NEXT? Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply, and we’ll be in touch as soon as we can. WHERE CAN I FIND OUT MORE? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ . We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. #J-18808-Ljbffr
Brand & Customer Manager – Biopharmaceuticals Location: Dublin, Ireland Competitive Salary and Benefits Closing Date: 29th November 2024 Hybrid role: Hybrid with 20-30% in-field focus. Introduction to role: Join us in our Biopharmaceutical Business Unit as a Brand & Key Account Manager, where you will support the development, implementation, and execution of the brand strategy in the Irish market. This hybrid role will involve a significant level of customer engagement nurturing the growth of key relationships for the successful implementation of the brand strategy and partnerships. Accountabilities: Responsible for the tactical delivery, localisation, and execution of the marketing plan across various channels. Manage brand sales forecast and annual brand marketing budget. Drive the creation of content to deliver an engaging brand experience across channels. Manage external engagement with key stakeholders, influencers, and decision makers. Manage external vendors and the promotional asset approval and compliance process with cross-functional partners. Use insights and performance data to ensure tactical execution - including account planning, targeting, and segmentation. Develop and implement strategic account plans to drive sales growth and maximize the value of each key account. Essential Skills/Experience: Strong commercial pharmaceutical experience with a strong performance track record. Experience working in a customer-facing environment. Strong sales and/or marketing leadership with a successful track record of growing market share. Creative multichannel marketing capabilities together with rigorous commercial business sense. Success working as part of cross-functional teams with great communication skills. Degree qualified – scientific, marketing, business. Desirable Skills/Experience: Experience of the Biopharmaceuticals therapy area – including knowledge of the healthcare environment. Experience in launching new medicines. Experience in managing Key Customer Relationships. At AstraZeneca, we change the practice of medicine and improve the patient experience by generating and communicating compelling medical evidence. We translate the wealth of medical and scientific expertise to ensure the data we produce helps physicians to better treat patients at every point in the journey. We are recognised as the strategic partner for Research & Development and Commercial. This means we have a deep and broad understanding of both functions, which enables us to effectively translate scientific evidence into clinical practice for patients. We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation! #J-18808-Ljbffr
Nous recrutons un(e) Assistant(e) Relations Clients AstraZeneca : AstraZeneca est un groupe biopharmaceutique international guidé par la science, axé sur la recherche, le développement, la production et la commercialisation de médicaments de prescription. Notre activité se concentre dans des domaines thérapeutiques majeurs : maladies cardiovasculaires et métaboliques, respiratoire, oncologie, neurosciences, maladies inflammatoires et auto-immunes, infectiologie et vaccins. Nous intervenons dans plus de 100 pays et nos médicaments innovants sont utilisés par des millions de patients à travers le monde. Vos missions : En tant que Assistant(e) Relations Clients, vous intégrerez une aire thérapeutique prioritaire pour AstraZeneca. Ainsi, vous travaillerez dans le respect des règles et des procédures groupe, en gérant la saisie des commandes spécifiques (accès précoce, échantillons, ESR, échantillothèque…), répondant aux demandes terrain concernant les ruptures en pharmacies, assurant le lien entre les équipes GENPACT et notre prestataire logistique CEVA, aidant au traitement des litiges logistiques (analyse). Vous participerez notamment aux projets suivants : Saisie des commandes accès précoce dans le système SAP Suivi des livraisons Vérification des commandes intégrées dans le système SAP Suivi du nombre d’échantillons par médecin Saisie des commandes spécifiques en fonction de la demande Suivi de la livraison Être l’interlocuteur privilégié en cas de remontée de rupture pharmacie Vérifier les commandes grossistes en cours en fonction de la remontée Répondre aux différentes questions du terrain par email ou sur le groupe dédié Suivre les litiges logistiques avec l’équipe du SRC (Genpact) Contact avec le prestataire logistique CEVA pour analyse du litige Aide Responsable relations clients Votre profil : Formation de base : Bac + 2 Administration des ventes Expérience professionnelle : 5 ans d’expérience dans un poste similaire dans un environnement industriel de préférence agro-alimentaire, cosmétique ou pharmaceutique. Connaissances techniques : SAP Langues étrangères : Anglais courant Informatique: Word/Excel/ Powerpoint/SAP Vous êtes organisé(e), autonome, réactif(ve), rigoureux(se), vous possédez un sens de l’adaptation, un bon relationnel et une bonne capacité de communication. #J-18808-Ljbffr
※ This position is for a 6-month fixed term. [Typical Accountabilities] - LinkedIn Communication Assist the development of strategic plans and content for LinkedIn campaigns aligned to local priorities. Collaborate with internal functions and external stakeholders in planning and execution of content. Management and monthly reporting of campaign coverage. Act as a community manager, monitoring comments three times a day, ensuring proper management and reporting in accordance with guidelines. Regularly update the channel's official comments with CFT discussions. Obtain review and approval for content via Veeva Vault. - Brand Campaign Alliance Support developing strategic plans and content for public campaigns in line with local priorities. Collaborate with internal functions and external stakeholders in planning and execution of content. Management and reporting of campaign outcomes to local and regional levels. Support planning and executing public events/college student programs while communicating with external stakeholders. Obtain review and approval for all contents via Veeva Vault. - CSR Program ‘Hope Fund’ Support developing strategic plans and content for Hope Fund Fall Event aligned to internal communication goal & external stakeholders needs. Operate Hope Fund Ambassador(TFT) consisted of employees. Management and reporting of event outcomes to local and regional levels. Obtain review and approval for all the materials via Veeva Vault (incl. banners, media/digital comm. contents, etc.). - Administrative Support Support IT/admin tasks for local & regional townhalls (arranging tech rehearsal, interpreters, etc.). Support follow up for media inquiries regarding major academic events (ex. ASCO, ESMO, etc.). Obtain review and approval for Corp. PR contents for media (BU contents are handled by BU admins). Daily monitoring & summarizing media results for internal reporting if needed. [Qualifications] - Education: Bachelor’s degree is minimum. - Language: Korean. [Preferred] - 2-3 years of experience in Healthcare/Pharmaceutical Communication Experience in planning PR activities (incl. CSR program, Internal event, Corp. PR, etc.) and execution. Proficiency in written English (preferred). - 2-3 years of experience in Communication (any industry) Experience in planning PR activities (incl. CSR program, Internal event, Corp. PR, etc.) and execution. Proficiency in written English (preferred). - Communication or Pharma related Major Excellence in interpersonal communication. Experience in any type of internship. Proficiency in English. #J-18808-Ljbffr
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. It’s our patients that come first; every decision we make and action we take is centred around how we can better respond to their evolving needs, as well as those of healthcare professionals and partners. It’s why we are shaping patient care for the future, working along the whole experience to give hope to billions of lives across the world. What you’ll do As a Local Study Associate Director, you will be leading the Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines, complying with AZ Procedural Documents and international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), as the Local Study Associate Director (LSAD), you may perform site monitoring as needed to support the flexible capacity model. Key responsibilities Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies. Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations. Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head). Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction). Proactively identifies risks and facilitates resolution of complex study problems and issues. Your profile Bachelor degree in related discipline, preferably in life science, or equivalent qualification. Proven previous experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies). Good knowledge of international guidelines ICH-GCP as well as relevant local regulations. Excellent verbal and written communication skills – Fluent English and Hungarian is a must. Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and with required quality. Excellent Project Management skills. Exceptional team building and interpersonal skills. Competent organizational skills. Excellent ability to prioritize and handle multiple tasks. Excellent attention to detail. Solid negotiation skills. Good ability to learn and to adapt to work with IT systems. Ability to travel nationally and internationally as required. So, what’s next? At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. #J-18808-Ljbffr
Immunology Business Partner - Delta Do you have expertise in, and passion for, Sales? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. BUSINESS AREA Get to directly impact the lives of patients by turning our deep and broad pipeline into a reality. Here patients always come first – we address unmet needs, from nephrology to immunology, and provide patient care along the entire journey. Have the opportunity to be involved in the next big thing, whilst making a meaningful difference to patients and wider society. What you’ll do Engage healthcare professionals in dialogue about approved indications and product efficacy/safety profiles to support on-label prescribing for appropriate patients Find innovative solutions for drug accessibility to patients Responsible for right positioning of the testing for treatment paradigm Responsible for different accounts mapping with engagement plan to different stakeholders Fill the gaps in patients' journey Ensure right positioning of the drug and right use throughout scientific message and engagement plans Follow up with all the stakeholders in the assigned accounts (Payers, Diagnostics, Purchasers & Pharmacists) Focus on all the cases to ensure proper diagnostics to establish testing concept Achieve sales target and assigned Sales KPIs in line with our policies and procedures Promote AstraZeneca’s portfolio and services by providing the latest and most relevant data and information to the right customer at the right time Support Healthcare professionals’ decision and optimize patient outcomes in an ethical way Leverage all available data sources to create, dynamically prioritize and adapt relevant territory and customer engagement plans Demonstrate advanced customer engagement skills to deliver high quality customer interactions and maximize customer experience for the benefit of patients Maintain a deep and current knowledge of the industry, trade association, competitors, buyer dynamics and focus effort on customer opportunities Build interpersonal inclusion through self-awareness, developing curiosity, active listening and strengthening team/peer inclusion. Essential for the role AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We all applicable laws and regulations on inclusivity in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Applicants should possess the following qualifications to go through initial screening: Pharmacy or Medicine graduate 2 Years Multinational Experience Immunology/Biologics/Rheumatology Experience is a must Mansoura or Zagazig Residency is a must Excellent communication skills in English/ Arabic Presentation skills, digital abilities and learning agility Experience with strategic accounts & KOL management Effective interpersonal and team building skills Completed military or other governmental obligations Driving license is required Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. #J-18808-Ljbffr
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. AstraZeneca is one of only a handful of pure-play biopharmaceutical companies to span the entire value chain of a medicine from discovery, early- and late-stage development to manufacturing and distribution, and the global commercialization of primary care, specialty care-led and specialty care medicines that transform lives. At AstraZeneca, we're proud to have an extraordinary workplace culture that drives innovation and teamwork. Here, we encourage our teams to express diverse perspectives - making you feel valued, energized and rewarded for your ideas and creativity. AstraZeneca is currently looking for a Release Manager to join our R&D IT Product Design & Delivery Team to manage delivery excellence for Analysis & Reporting Product, part of Operational Clinical Development Platform, that is used by late science teams across all therapeutic areas. You will be a part of our core BizDevOps team therefore will be responsible to work cross-functionally with other team members such as IT Platform & Product Leads, Business Analysts, DevOps Engineers and key business stakeholders such as BPO, Product Owners and Quality Managers. KEY RESPONSIBILITIES: Oversee the SDLC and end-to-end Release Management process in Analysis & Reporting multicomponent product (incl. EntimICE, SAS Grid and LSAF). This encompasses enablement and ownership of processes, tooling, engineering standards, value stream, documentation artefacts and metrics. Proactively identify process optimization and improvements ensuring delivery excellence, maximising productivity both in functional and integration components of the product. Applying Product Design & Delivery best practices to enable common platform ways of working. Report on process compliance, KPI's and any process performance trends. Schedule releases across Scrum Teams and OCD Platform Modules. Provide Release Notes to the appropriate stakeholders and ensure deployments are planned well and executed efficiently taking into consideration business study submission calendar and their priorities. Manage release dependencies between upstream and downstream systems. Plan deployments, implementations and help optimize JIRA workflows with responsible teams. Lead SAFe ceremonies such as PI Planning, Product SCRUM, Sprint Plannings, Sprint Retrospectives. Ensure Change & Configuration Management compliance across GxP environment for system inspection readiness. Manage release capacity and provide deployment forecast with the delivery team, based on a consolidated backlog. Identify opportunities for automation uplift, including implementing CI/CD tooling, testing automation, and process improvements. Liaise with Business Teams and BAs on backlog priorities to achieve sprint goals. Manage product risks and issues that affect agreed release scope, schedule, and quality. Help influence the decision making among Product Owners and Platform/DevOps Leads to prioritize change requests during planning and/or execution. Produce required documentation for the releases (e.g. Master Validation Plan, Master Test Approach, Validation Reports, Change & Configuration Management SOPs). MANDATORY SKILLS: 5 years of experience within relevant IT areas. Deep knowledge and understanding of Release Management practices and principles. Proficiency in planning, change management, and problem-solving and ability to resolve issues of a complex and strategic nature. Familiarity with tools such as Jira, ServiceNow, Miro, Airfocus. Experience in managing and delivering business change through IT projects. Ability to interpret and communicate technical information into business language. Ability to manage negotiations, expectations, and solutions across complex groups. Experience in managing and sustaining diverse stakeholder relationships in a multi-vendor environment. Quality mindset is a must. PREFERRED SKILLS: Experience with regulated (GxP) systems and processes + knowledge of biopharma industry. Strong understanding of SDLC practices, including Git, CI/CD, and infrastructure as code (IaC). Hands-on experience with SAFe Lean-Agile methodologies. Ability to handle multiple projects simultaneously in a fast-paced environment. Excellent relationship management and conflict resolution skills, with the ability to influence others. Proven ability to operate across multiple domains and geographies. EDUCATIONAL REQUIREMENTS: Bachelor’s or Master’s degree in Computer Science, Business or related field. We will hire self-taught engineers without a formal education given that you have evidence of rich history in IT. ITIL V4, Agile, DevOps and other technical/quality certifications are a plus. #J-18808-Ljbffr
