AstraZeneca

9 job(s) at AstraZeneca

AstraZeneca Macclesfield, Cheshire
Sep 23, 2022
Full time
Legal Manager, Corporate Legal Competitive salary and benefits apply Location: Macclesfield or Cambridge At AstraZeneca, we believe in the potential of our people and you'll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're curious about what science can do, then you're our kind of person The Legal Manager within the Corporate Legal team reports to the Assistant General Counsel, Digital, IT & Operations and works under the supervision of the senior lawyers in the Corporate Legal team, helping to manage legal risks, liaising with business functions and the broader AstraZeneca Legal function, as appropriate. The role is based in either Macclesfield or Cambridge. Typical Accountabilities Assists AstraZeneca lawyers with corporate, commercial and project related support activities, such as drafting ancillary documents, preparing schedules and overall project management Assists the Senior Director, Competition Law with merger filings with and information requests and responses with various global competition authorities Assists the Senior Director, Operations Legal with manufacturing and supply chain issues Acts as primary contact for quality incidents with legal risk and advises directly or escalates within the team, as appropriate Supports the global employment legal group on information collection matters and project management Leads various knowledge management and best practice sharing initiatives within the team, including updates to deal templates, guidance documents and other tools and resources Acts as the primary interface in contract capability uplift initiatives by the team Ensures collaboration with other areas of Legal to ensure a seamless service by Legal Supports special projects such as supporting technology and automation initiatives and best practice sharing Essential skills and experience: Law firm or in-house experience, particularly in commercial, corporate and/or contract law Excellent interpersonal and communication skills to explain often complex legal issues in an easy-to-understand manner Business oriented and pragmatic approach to problem solving Excellent organizational and project management skills Excellent drafting skills Desirable skills and experience Law degree or law school qualification Experience of working in a global legal environment Pharmaceutical or other regulated industry experience Experience working in-house in a multinational company Experience working with 'English law' contracts Experience with driving adoption of legal technology 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 spark 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. So, what's next? Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours. Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn - Follow AstraZeneca on Facebook - Follow AstraZeneca on Instagram -
AstraZeneca Cambridge, Cambridgeshire
Sep 22, 2022
Full time
Do you have expertise in, and passion for Medical Affairs in Oncology? Would you like to apply your expertise to impact the Global Medical Affairs Breast Cancer Strategy Lead role in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through five key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, HER2 and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies. Job Description: You will be joining our globally-renowned Oncology area, which is currently leading the rapid business growth of our enterprise and ever-evolving industry. It is an exciting time to join as we work towards our big ambitions using entrepreneurial thinking and innovation. It is up to us to find solutions and act fast to make them a reality. Science is at the core of our decision making. It is how we achieve our ambitions for patients: fusing science with strategy, embracing new opportunities, and cultivating innovation by seeking expertise in real world evidence and data. To accompany AstraZeneca's continued commitment to improving the lives of persons with Breast Cancer, we are pleased to present a new and unique role. This senior role is a critical position with high visibility and impact, providing the individual the opportunity to unleash the full potential of Medical Affairs on a Global scale. Reporting to the Vice President, Global Franchise Head, this senior position is accountable for the strategic direction, and matrix leadership of the Global Medical Affairs (GMA) Breast Cancer Plan, integrating innovative strategies that drives towards improved patient care. The post holder will be responsible for the alignment, coordination, and implementation of the overall GMA pan-Breast Cancer strategic initiatives that sit above the Breast Cancer brands. As a core member of the Global Medical Breast Cancer Strategy Team you will work in a cross-functional environment with senior stakeholders to positively influence the direction and priorities of the AZ Breast Cancer Strategy. As the post holder represents the GMA function, you will proactively engage Global Medical Teams and Stakeholders to ensure GMA alignment and consistency of delivery against the Breast Cancer Strategy. You will also be a strong representation of GMA within the cross-functional Oncology Global Product and Oncology Global Commercial Brand Teams, as well as within collaborative clinical research programmes. Your focus will also include strengthening and expanding our external engagement strategy and partnerships with the clinical community through consolidation of our real-world evidence and collaborative research programmes. Ultimately, playing a leading role in defining and transforming future breast cancer care models to improve patient lives. You will be accountable for: The leadership and development of the strategic direction and deliverables across all areas of Medical Affairs in support of the Breast Cancer strategy Congress plans, including KEE engagement, symposia, IME/CME, communications including Q&A Evidence generation including RWE, diagnostics, and translational work Digital innovations Delivering the above brands Breast Cancer Scientific Narrative Development of the platform for external collaboration and engagement as part of the comprehensive external engagement Breast Cancer strategy You will work: Collaboratively with the Breast Cancer Franchise Head and Breast Cancer Development Head in the design and implementation of the integrated Breast Cancer strategy With the Alliance team to harness synergies in having an external impact through the Alliance and AZ strategy execution With internal and external stakeholders to enhance the scientific and clinical understanding of Breast Cancer You will: Lead Pan Breast Cancer Strategy team and execute Pan BC initiatives Serve as the Medical Affairs lead on the Breast Strategy Council , bringing the voice of the patient and physician into the development and commercialisation process Ensure that medical insights from key countries are used to inform all evidence, product development, and franchise strategy deliverables Maintain a good working knowledge of company standards on medicines promotion and supports the Nominated Signatories in ensuring product related materials and activities for external audiences comply with these standards Initiate and develop relationships with internal and external stakeholders to enhance the scientific and clinical understanding of the AZ Breast cancer strategy Develop, gain approval for, and manage the annual budget required to deliver the objectives for assigned brand(s) in line with defined processes and policies Act as an expert author to the Late-Stage Target Product Profiles (TPPs), starting 9-12 months before Phase III ID (investment decision) bringing insights from providers, patients, and policy makers, knowledge of the patient journey, treatment impact and translation of efficacy to effectiveness Essential Requirements: Advanced scientific degree (MD, PhD, PharmD) Extensive Medical Affairs and product launch experience including deep Breast cancer experience Strong understanding of drug development and the commercialization processes including launch experience A track record of building and maintaining a deep continued connection to medical practice/healthcare delivery Collaborative/matrix management skills with a focus on leading diverse groups (e.g., cultural, geographical, functional) to achieve excellent results in shared goals Strong communication skills with the ability to distil complexity down to what matters to our stakeholders (Fluency in English - essential) Proven ability to generate, analyse and interpret clinical trial and published data The candidate is expected to have strong project management skills and ability to work effectively cross-functional/cross-Franchise globally including development, marketing, diagnostics, and health outcomes Strong Financial/Budget Management and business acumen Desirable Requirements Extensive knowledge of the latest technical, regulatory, policy and patient-centric developments Experience in Evidence generation planning and clinical trial design Extensive experience in relationship and stakeholder management (3P's: Payer, Provider and Patients) Effective matrix leadership experience Experience working at the medical marketing interface Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey. Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram
AstraZeneca Cambridge, Cambridgeshire
Sep 22, 2022
Full time
Register your interest for an Information Practice role Location: Cambridge or Macclesfied (UK), Gaithersburg or Wilmington (US) Competitive salary and benefits Are you a Clinical Information Scientist - experienced or in the beginning of your career? If you would like to apply your expertise in a global company pushing the boundaries of science - join us! A straZeneca 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 disease. But we're more than one of the world's leading pharmaceutical companies. We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process. We are offering opportunities for Clinical Information Scientist and Scientist Leaders at several different career levels , depending on your previous experience. You will join a global, diverse and cross-functional environment where you will get personal and professional development. In this role you will support global clinical directors and trial design teams in finding and structuring clinical information driving optimal designs for late stage drug development . It sits within our Information Practice unit who enterprise reuse of clinical information and knowledge retention for better informed decision-making and clinical development. Main Duties and Responsibilities Embedded within dynamic oncology drug project teams, you will ascertain and deliver the information clinical teams need to assist them in making decisions driving the drug development process. For example, using a variety of information sources such as ClinicalTrials.Gov, BioMed Tracker, and internal clinical databases. You will also contribute to key drug meetings and committees by establishing the scope, goals and deliverables supporting business goals in collaboration with senior management and decision makers. The significant areas for contribution are: Clinical Design Support decision-making in clinical design by identifying, extracting and presenting back meaningful facts and data via internal and external information sources Building a repository of key data bringing together key historical decisions for wide team to use and refer to (build the memory of clinical trials ranging from Phase IIb thru registration and life cycle management) Contribute to the design team by collaborating with project stakeholders to plan and schedule project timelines, while tracking project landmarks and preparing progress reports Disseminate key clinical information Using techniques such as: text mining, data visualisation, competitor intelligence, and bench-marking extract key relevant information proactively enabling clinical drug design decision makers to make timely and objective decisions Facilitate access to complex information for the drug project and ensure access to and (re)use of clinical information, documents and data Essential Requirements To succeed in this opportunity, you will have a real passion for clinical data and information - in particular knowing what information you require, how to seek it out, and how to share it with the teams in an insightful way. You'll be excited by the prospect of being embedded within late stage drug development projects. An excellent communicator with great listening skills, who can absorb information and respond in a concise manner. In addition, you will also have: Bachelors or advanced degree in a Life Science Sound understanding of the pharmaceutical clinical drug development process (with a preference for late-stage drug development) Good understanding of project management techniques and methods Experience in clinical information or science information setting in the application of information and knowledge management (settings could include, but are not limited to clinical drug development, medical writing, medical affairs, clinical operations, competitor intelligence, regulatory intelligence) Good organisational skills and the ability to multitask; can set priorities and follow a timeline Great attention to detail 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. So, what's next? Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours. Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Please visit our dedicated Biometrics webpage 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. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
AstraZeneca Macclesfield, Cheshire
Dec 07, 2021
Full time
*Trade & Customs Manager - Clinical Manufacturing & Supply* *Macclesfield - UK, Gothenburg - SE, Warsaw - Poland or Gaithersburg - US* *Competitive Salary & Benefits* *Date Posted: *06.12.21 *Bring out the best in each other, and yourself, by working together as one* In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace! We currently have an opening for a *Trade & Customs Manager* to join our Clinical Manufacturing & Supply team. The Global Clinical Supply Chain (GCSC) function is accountable for the supply of medicines to support AstraZeneca's clinical trials. This includes planning, drug substance manufacture, drug product manufacture, packaging and distribution to depots / clinical investigator sites. In this role you will ensure adherence to AstraZeneca's principles on trade management, customs and compliance as development products move through their lifecycle is a key activity. Reporting to the Associate Director, Clinical Distribution, this position will have responsibility for the trade and customs management activities relating to clinical supply chains and distribution. You will be a subject matter expert on international trade and customs regulations and the requirements relating to the import and export of pharmaceutical products throughout global supply chains. In addition, you will be responsible for the trade and customs master data required to ensure the smooth flow of products to serve AstraZeneca's clinical supply chain. The Trade & Customs Manager will identify and lead improvement projects to increase customs compliance, supply chain agility and savings opportunities. *What you'll do:* * Ensure trade and customs compliance * Support the smooth flow of product globally * Own trade and customs Risk Management (evaluation of risks and implementation of suitable mitigations) * Be the lead Subject Matter Expert and key contact to all user groups and stakeholders, including: * Internal teams * External vendors * Customs and Regulatory authorities * Be the Business Process Owner for Trade and Customs * Provide guidance and deliver training to key user groups and stakeholders * Coach/mentor the Trade and Customs Coordinator * Monitor changes to global import / export / customs requirements and ensure that relevant changes are implemented * Support the Associate Director, Clinical Distribution to deliver the overall clinical distribution strategy *What you'll need* *Essential:* * MBA or other Finance / Business qualification relating to International Trade * Strong experience within a trade and customs environment * Strong understanding of Customs laws and how they apply to global supply chains * Experience of working across a global organisation and with senior leaders * Excellent analytical skills * Excellent interpersonal and communication skills with the ability to identify and communicate key issues for resolution * Ability to effectively interact within AZ functional areas and external service providers * Ability to evaluate/manage relationships with external service partners *Desirable:* * Familiarity of the pharmaceutical/clinical supply chain environment * Financial or budgeting experience * Working knowledge of the logistics industry and the various government agencies and regulations involved with the distribution of products 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. Always committed to lifelong learning, growth and development. *So What's Next?* Please apply including your CV and Cover Letter by 19th December 2021. *Close Date: *19th December 2021
AstraZeneca Macclesfield, Cheshire
Dec 05, 2021
Full time
*Improvement Engineer * Macclesfield Competitive Salary & Benefits Make a positive impact, in a team where it means more. We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people's lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalisation and sustainable practices. Macclesfield supplies products for most of AstraZeneca's therapy areas and currently sources over 130 markets worldwide. Many of AstraZeneca's biggest brands are formulated and packed for distribution at Macclesfield. We are now seeking an Improvement Engineer to work within the Packing Department at the Macclesfield site which is part of UK Operations, the 2nd largest operational site within the AstraZeneca network. Packing supplies an extensive range of AstraZeneca products to markets around the globe. The products cover oral solid dose tablets presented in either blister strips or bottles through to syringes. Macclesfield is additionally a key site for launching new products. The Improvement Engineer provides improvements, governance, CapEx/Revenue portfolio management and technical expertise to the Packing Department to optimise assets, process and investment priorities, and to demonstrate sustained improvements. You'll join AstraZeneca and Packing at a very exciting time where we are looking to digitise our processes and make the factory of the future a reality. We are always looking for opportunities to stream line our processes with the very latest technologies such as the use of Cobots to work alongside our work force. Here at AstraZeneca we have made LEAN a component of our licence to operate right alongside Safety and Quality. We are making Lean a foundation in our strategy to give us top quartile lean performance moving us from "Good" to "Great", without this we will not be competitive or enable AstraZeneca's bold ambition. Lean needs to be embedded in everything we do. *Responsibilities* As an Improvement Engineer you will provide key technical and engineering support to the manufacturing area. This will include identifying and driving improvement initiatives in maintenance and technology as well as progressing and supporting key projects such as assessing fit for purpose assets and equipment reliability. Your technical expertise will be used to prioritise improvements via risk management and benefits analysis. Through the application of technical aptitude, engineering tools, systematic processes and good engineering practices, you will be responsible for the delivery and management of asset improvement initiatives, process improvements and project delivery. You'll be required to lead or participate in Project Management for revenue and capital improvement projects. Responsibilities will include management of changes on behalf of the manufacturing teams. Packing has a vast project portfolio ranging from small projects to the larger projects such as the introduction of new packing lines. You will have the ability to analyse process inputs, processes and process outputs to understand and improve the overall process capability. You can define, measure, analyse, and control the product/process and interactions. Define and create targeted improvements that reduces and controls the variability in the process or improves the robustness of the manufacturing asset. *Desirable Criteria:* * Proven expertise in analytical problem-solving methodology * Significant & relevant delivery experience of equipment & process improvement practices within a highly regulated manufacturing environment (Pharmaceutical Manufacturing) * Relevant technical/engineering degree (or appropriate experience) * Statistical benefit needs analysis understanding (data set justification etc.) * Technical report writing & generation * Reactive and proactive technical support within a manufacturing environment including experience with equipment and materials within a packaging environment would be beneficial * Experience of working and delivering initiative and project based activity * OEE/Pareto understanding & improvement * Practitioner in change control implementation * Understanding of Qualification/Validation Interested in this opportunity? Then apply today, we are waiting for your application!
AstraZeneca Macclesfield, Cheshire
Dec 04, 2021
Full time
*Distribution Coordinator - Clinical Manufacturing & Supply* *Macclesfield - UK, Gothenburg - SE, Warsaw - Poland or Gaithersburg - US* *Competitive Salary & Benefits* *Date Posted: *03.12.21 *Be empowered to be innovative and creative where difference is valued* 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. The Global Clinical Supply Chain (GCSC) function is accountable for the supply of medicines to support AstraZeneca's clinical trials. This includes planning, drug substance manufacture, drug product manufacture, packaging and distribution to depots / clinical investigator sites. The Clinical Distribution team within GCSC has the accountability to ensure the distribution and logistics requirements of our supply chains are being met. We currently have an opening for a *Distribution Coordinator *to join our Clinical Manufacturing & Supply team. *What you'll do:* Reporting to the Associate Director, Clinical Distribution and part of the Clinical Distribution team, this position will have task-based activities relating to clinical supply chain and distribution. *Job Responsibilities:* * Help ensure logistics lead times, FSI (First Subject In) and Right First Time targets are achieved * Support the Distribution Liaison Partner (DLP) with dedicated distribution support for selected clinical studies * Liaise with external logistics partners to ensure shipments are executed correctly and on time * Ensure required import/export documentation is created for shipments * Help manage queries to the Distribution mailbox * Be part of the Clinical Distribution team to ensure operational performance is being achieved and improvement initiatives are being delivered, including ownership of smaller initiatives * Support the development and maintenance of processes, tools, guidance, templates and training * Be a contact person for internal and external teams * Build their own expertise and knowledge * Support the Associate Director, Clinical Distribution to deliver the overall clinical distribution strategy * Follow SHE and GXP standards *What you'll need* *Essential:* * Experience in a supply chain / logistics environment * Desire to increase knowledge within Logistics area of supply chain * Analytical skills * Strong and clear communication skills *Desirable:* * Degree in Supply Chain / logistics or other relevant business discipline * Experience with lean tools and methodologies * Familiarity of the pharmaceutical/clinical supply chain environment * Working knowledge of the logistics industry and the various government agencies and regulations involved with the distribution of products 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. Always committed to lifelong learning, growth and development. *So What's Next?* Please apply including your CV and Cover Letter by 19th December 2021. *Close Date: *19th December 2021
AstraZeneca Cambridge, Cambridgeshire
Dec 02, 2021
Full time
*Would you like to use your drug safety or pharmacovigilance experience to make a difference to the lives of millions of patients across the world? If you would, please read on!* At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing. This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians play a strategic role in developing our medicines and the safety science of the programme. AstraZeneca's oncology pipeline, which includes novel combinations and modalities, provides an intellectual challenge to the safety teams, requiring a broad portfolio and scientific management approach to projects. Our teams' experience develops as our portfolio does. We are looking for an experienced Associate Director, Patient Safety (PS) Scientist to join our Patient Safety department, working in the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians, including coaching junior colleagues. You will play a leading role in delivering the safety strategy and requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams. As an Associate Director, PS Scientist, you will provide leadership in aggregating, reviewing, analysing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protecting patients. You will apply your strong PV, oncology and scientific experience, knowledge and skills to lead in all aspects of safety documentation, including authoring and / or providing strategic safety input to regulatory documents, e.g., regulatory reports, health authority responses and the safety content of marketing authorisation applications. Patient Safety sits within the Chief Medical Office, where we have a crucial role to play. This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. Faced with complex disease challenges, we focus on exceptional performance to drive the best and most transformative drug development programmes ever. *Essential Requirements* * A Bachelor's in sciences/pharmacy/nursing degree or related field with relevant experience or an advance degree with relevant experience * Patient Safety and/or Clinical/Drug Development experience working in or leading safety &/or scientific activities in at least 3 of the following areas: * Clinical drug development (Early and/or Late Phase: develop programme level safety strategy, including proactive risk identification & mitigation planning) * Post-Marketing Surveillance (including signal detection & evaluation) * MAA/BLA submissions (setting strategy; preparation and authoring of the safety related aspects of the Common Technical Document) * Periodic Safety Reports (establish and lead strategy, preparation and authoring) * Risk Management Plans (establish and lead strategy, preparation and authoring) * Governance board interactions and communication across a range of activities * Good knowledge of PV regulations * Demonstrated ability to handle more than one project simultaneously, prioritizing well and recognizing key issues * Ability to work effectively in an advanced matrix structure * Fluent in written and verbal English *Preferred Requirements* * MSc/PhD/PharmD in scientific discipline * Advanced understanding of epidemiology *Location:* Cambridge UK *Salary: *Competitive + Excellent Benefits *Closing Date:* 14th December 2021 *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. *So, what's next?* Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. *Where can I find out more?* Our Social Media, Follow AstraZeneca on LinkedIn []() Follow AstraZeneca on Facebook []() Follow AstraZeneca on Instagram []()
AstraZeneca Cambridge, Cambridgeshire
Dec 02, 2021
Full time
*Senior Global Medical Affairs Leader, Respiratory* *Location: Wilmington, DE/Gaithersburg, MD/Cambridge, UK/Gothenburg, SE* *Competitive salary* Job posting start date: 30/11/2021 Job posting end date: 24/12/2021 At AstraZeneca we win through science, it's at the heart of our every success. That science is only possible when we all work together - we'll always make sure you're clear about how your role is connected to our wider mission to really show what science can do. The Global Medical Affairs function ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca therapies and supports our internal stakeholders with medical insight and expertise. This global role provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. Medical Affairs aims to lead AZ in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do. *What you'll do:* * Design and manage the implementation of the global medical product strategy globally and regionally * Work with the Medical Head to create and develop the strategic direction, business/resource planning, and team leadership on a global level * Be a proactive member of the Global Medical Team (GMT) to ensure global strategy is effectively communicated and executed at regional and country levels and that regional/country needs are appropriately accommodated in global deliverables and drive customer insights and market needs from all countries into Global Product Team for review * Collaborate cross-functionally with GMA functions (eg Global Medical Excellence & Medical Evidence) * Closely follow medical developments and competitive landscape within Therapeutic area and disseminate new information to transform clinical trends and emerging data into strategy * Be an active contributor to the cross functional congress planning team * Provide input, as needed, into labelling (USPI, SmPc) and core data sheet discussions * Liaise with the internal and external medical community * Deliver medical advocacy plan that drives successful launch of innovative and differentiated new medicines or indications within the therapy area * Support team leader at TA Global Product Team and Global Brand Team * Accountable for engaging and cultivating relationships with leading global KEEs to gain: contribution/ participation in advisory boards, greater understanding of the therapeutic area and insights into unmet patient needs * Represents AZ at scientific and medical forums, including medical education forums, scientific roundtables, congresses, and symposia * Responsible for the co-ordination of Medical Affairs activities including developing content for Science Advisory boards * Ensuring the alignment of the publication and medical evidence plans to the Medical Strategy and Medical plan * Delegate for the Medical Head as required * Manages other specific respiratory/medical projects as required * Responsibility for managing particular areas of the budget * Provide medical strategic and scientific input into assessment of investigator initiated studies as a member of the GREG * Be an active member of team(s) for assets in development while providing medical strategic input *Essential for the role: * * Doctoral level degree: MD/PhD/PharmD * Expertise in the relevant or related therapy area * Demonstration of strategic and medical leadership prowess * Personal experience in the design and conduct of interventional and/or observational studies is ideal, but not mandatory * Experience supporting an indication, promotional claim and scientific exchange including input into clinical development plan and TPP * Track record of building and maintaining a deep and continued connection to Medical Practice/healthcare delivery * Collaborative/matrix management skills with a focus on leading diverse groups (e.g., cultural, geographical, functional) to achieve excellent results in shared goals * Well-developed communication and influencing skills with the ability to distil complexity down to what matters to our stakeholders * Strong financial/budget and project management skills/business acumen *Why AstraZeneca?* At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. *So, what's next! * Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
AstraZeneca Cambridge, Cambridgeshire
Dec 01, 2021
Full time
Please note the role is site-based in Cambridge, UK. It is not a remote working opportunity. Medical information at AstraZeneca is responsible for the strategic planning, development and implementation of medical content and communication for health care professionals using various channels, including digital, to support patient care. A combination of global and US remits provides the opportunity to collaborate internationally and drive strategically-aligned and consistent medical communication. The Senior Medical Information Manager is responsible for the proactive planning, development of scientific content to support Medical Affairs, providing scientific consult, review & approval of promotional materials, and answering medical inquiries from healthcare professionals to bring value to our customers and ultimately the patient. Additionally, this role empowers forward-thinking and digital innovation to help drive operational efficiencies and engaging scientific exchange. *Key Responsibilities:* *General* * Strategic application of scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape * Collaborate with key stakeholders to strategically plan and execute scientific information development and dissemination to meet customer needs * Monitor the medical environment and apply scientific expertise, integrated with regulatory/compliance landscape, and local markets knowledge to impact Brand/Therapeutic Area strategy * Contribute to processes related to MI operations, drive operational excellence, and support digital innovation through forward and innovative thinking to meet business needs efficiently *Scientific Content/Brand Partnership* * Strategically lead and/or provide oversight of others in the development, review and maintenance of scientific communication materials, including Managed Market documents, for various channels (e.g., MI requests, digital, Field Medical) in collaboration with Medical Affairs for global and US market * Represents Medical Information within the promotional review cross functional team by: * Providing strategic scientific consults on brand messages * Reviewing promotional materials for content, accuracy, and final MI approval * Collaborating across the business to ensure promotional and nonpromotional materials are strategically aligned * Provides guidance for the appropriate use of AZ products by reviewing resources developed by external compendia (e.g. evidence-based practice centers, treatment guidelines, Medical Letter) *Customer Engagement* * Provides oversight of others and/or responds to medical information inquiries from Health Care Providers via multiple channels * Delivers accurate, focused, and scientifically balanced clinical and scientific information exchange with Health Care Providers that support the appropriate use of AstraZeneca products. * Identify, analyse and report trends in medical and scientific insight (including medical inquiries) to Medical Affairs stakeholders and assess the need to update or create scientific materials (standard responses, slide decks, and Q&As). *Qualifications/Skills & Competencies* * Advanced scientific degree required (PharmD preferred, MD, PhD, MPharm or equivalent) * Solid drug/medical information experience gained in pharmaceutical industry or comparable experience with the healthcare/clinical/hospital environment is required * Experienced with scientific literature evaluation and analysis * Strong verbal and written communication skills * Strategic thinker with strong business acumen, leadership, project management, and organizational skills * Digital strategy oriented mindset and experience a plus * A drug information or clinical residency/fellowship preferred * Promotional review and medical review experience preferred * Experience in medical communications/content creation (e.g., slide decks) preferred * Managed Markets/Payers/HEOR experience preferred * Ability to apply local regulatory (e.g. FDA, EMA), legal, and compliance requirements to Medical Affairs activities and drug information delivery * Ability to travel to meetings/conferences (domestic and international) approximately 5% of the time