Beijing, Beijing, China · On-site
Typical Accountabilities: - Support Global Study Leaders (GSL) and Global Study Associate Manager (GSAM) by completing delegated study work. - Initiate and lead the set-up of the electronic Trial Master File (eTMF). Main…
Skills: eTMF Management, ICH/GCP Guidelines, Clinical Trial Transparency, Regulatory Documentation, Budget Tracking
Beijing, Beijing, China · On-site
Typical Accountabilities: - In partnership with AZ enablement team, other AZ clinical experts and external service providers, the GSAM provides oversight to ensure study delivery. - Leads/contributes to the preparation o…
Skills: Clinical Study Oversight, CRO Management, Project Management, ICH/GCP Guidelines, Budget Management
Ho Chi Minh City, Vietnam · On-site
Account Specialist/Manager – Rare Diseases – HCM About AstraZeneca and AstraZeneca Vietnam AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, develo…
Skills: Key Account Management, Pharmaceutical Sales, Specialty Care, Rare Disease Knowledge, Strategic Planning
Bangkok, Thailand · On-site
The role is to plan, provide professional advice and expertise, and deliver practical tender support to the Sales team, Marketing, and related functions (e.g., Key Account Manager, Regulatory Affairs, etc.) in contractin…
Skills: Tender Management, Strategic Pricing, Market Analysis, Government Procurement, Negotiation
Gothenburg, Västra Götaland County, Sweden · On-site
$218k–$328k/yr
AstraZeneca is a global, science‑led, patient‑focused biopharmaceutical company that discovers, develops, and commercializes prescription medicines for some of the world’s most serious diseases. We work in a fast‑paced, …
Skills: Health Economics, Payer Evidence, Market Access, Pricing Strategy, Economic Modelling
Courbevoie, Ile-de-France, France · On-site
Notre entreprise : 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 activ…
Skills: Onboarding, HR Administration, Microsoft Office, English Proficiency, Budget Tracking
Singapore, Singapore · Hybrid
Job Title: IT Business Analyst Career Level: E Introduction to role: Be part of history in the making. AstraZeneca is building its first‑ever biologics manufacturing campus in Singapore—a USD 1.5 billion, innovative hub …
Skills: Business Analysis, Project Management, AI/ML Implementation, Biopharma Manufacturing, SAP S/4HANA
Hamburg, Germany · On-site
Innovativ, dynamisch und nachhaltig: Als eines der weltweit führenden Unternehmen der forschenden Arzneimittelindustrie bieten wir bei AstraZeneca die besten Möglichkeiten für Ihre persönliche und berufliche Entwicklung.…
Skills: Account Management, Strategic Customer Development, Communication Skills, Teamwork, Flexibility
Petaling Jaya, Selangor, Malaysia · On-site
Do you have expertise in, and passion for developing and implementing marketing plan & strategy in Oncology? Would you like to apply your expertise to impact in a company that follows the science and turns ideas into lif…
Skills: Marketing Strategy, Market Research, Product Lifecycle Management, KEE Advocacy, Demand Forecasting
Bengaluru, Karnataka, India · Hybrid
Job Title: Senior Analyst - Brand Analytics Career Level: D1 Introduction to role: Are you ready to turn sophisticated healthcare data into decisions that develop oncology brands and improve patient journeys? How would y…
Skills: Python, SQL, PySpark, Databricks, Power BI
Warsaw, Masovian Voivodeship, Poland · Hybrid
Location: Warsaw, Poland Hybrid model of work: 3 days in office, 2 remote per week Type of contract: 12 months fix term Label Specialist leads Label development projects/programmes. The individual has a working knowledge…
Skills: Clinical Trial Label Creation, Regulatory Compliance, Project Management, GxP Knowledge, Stakeholder Management
Chennai, Tamil Nadu, India · Hybrid
Job Title: Senior Consultant - SAP ESG and SAP EHS GCL: D1 Introduction to role: Turn your expertise into measurable impact for patients and the planet! Based in Chennai, this role shapes how we measure, handle, and repo…
Skills: SAP Sustainability Footprint Management, SAP Sustainability Control Tower, SAP EHS, SAP Global Label Management, SAP S/4HANA
Bengaluru, Karnataka, India · Hybrid
Job Title: Analyst - Data Scientist Grade : C3 Shift: 2 pm to 11 pm ISTRole: Individual contributor role.Location: Manyata Tech Park, Bangalore. Introduction to role: Are you ready to dive into the world of commercial an…
Skills: Python, SQL, Snowflake, AWS, Apache Airflow
Ho Chi Minh City, Vietnam · On-site
Account Specialist/Manager – Rare Diseases – HCM About AstraZeneca and AstraZeneca Vietnam AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, develo…
Skills: Account Management, Pharmaceutical Sales, Rare Disease Expertise, Strategic Planning, Cross-functional Collaboration
Osaka, Japan · On-site
Job Description 【ミッション】 優れた製品を一人でも多くの患者さんに届け、患者さんのためにサイエンスに再投資し続けられる製薬企業として競合優位性を維持し続けることに貢献する 【業務の範囲】 ・ブランドチーム、関係部門と協力しながらビジネス課題を特定・構造化・分析し、課題を解決するための製品戦略および実行プラン（National sales plan 短期プラン 1年）を立案 ・プラン策定のための市場調査の実施・結果の分…
Skills: Market Analysis, Product Strategy, KOL Management, KPI Monitoring, Cross-functional Collaboration
Bengaluru, Karnataka, India · On-site
Job Title: Analyst - Project Management Support GCL: C3 Introduction to role: Are you ready to bring financial difficulty and operational transparency to sophisticated, global technology initiatives that ultimately help …
Skills: Financial Management, Project Management, Procure to Pay, Microsoft Excel, Coupa
Tokyo, Japan · On-site
This is what you will do: Associate Director, Hematology Marketing will plan to launch Ravulizumab for HSCT-TMA (Hematopoietic stem cell transplantation associated TMA). S/he will plan and execute commercial launch tacti…
Skills: Strategic Thinking, Product Launch, Financial Planning, Sales Forecasting, KOL Engagement
Tokyo, Japan · On-site
This is what you will do: Associate Director, Hematology Marketing will plan to launch Ravulizumab for HSCT-TMA (Hematopoietic stem cell transplantation associated TMA). S/he will plan and execute commercial launch tacti…
Skills: Pharmaceutical Marketing, Product Launch, Strategic Planning, Financial Planning, Sales Forecasting
Petaling Jaya, Selangor, Malaysia · On-site
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're mo…
Skills: Accounts Receivable, Collections, Debt Analysis, AR Factoring, Reconciliation
Hamburg, Germany · On-site
Innovativ, dynamisch und nachhaltig: Als eines der weltweit führenden Unternehmen der forschenden Arzneimittelindustrie bieten wir bei AstraZeneca die besten Möglichkeiten für Ihre persönliche und berufliche Entwicklung.…
Skills: Omnichannel Strategy, Digital Transformation, Agile Methodologies, Business Process Optimization, Stakeholder Management
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Support Global Study Leaders by managing the electronic Trial Master File and coordinating clinical-regulatory documents. Handle administrative logistics, budget tracking, and meeting arrangements to ensure compliance with ICH/GCP guidelines.
A degree in medical or biological sciences is preferred, along with proven organizational and analytical skills. Candidates must be proficient in English and have a working knowledge of clinical study processes and GCP guidelines.
Typical Accountabilities:
- Support Global Study Leaders (GSL) and Global Study Associate Manager (GSAM) by completing delegated study work.
- Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs
- Interact/collaborate with Site Management & Monitoring, other internal staff and external vendors in collection of regulatory and other essential documents.
- Contribute to electronic applications/submissions in ANGEL by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR
- Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements
- Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. VCV/VQV, SharePoint, BOX if used, MS teams and study team shared mailbox) and support team members in the usage of these tools
- Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs
- Support the GSL/GSAM with tracking, reconciliation and follow-up of the study budget/payments in relevant systems (e.g. Accord, Coupa, FIND)
- Contribute to application, coordination, supply and tracking of study materials and equipment. Contribute to collection of study supplies, if required, at the study close-out
- Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs
- Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings e.g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors
- Prepares, contribute and distribute presentation material for meetings, newsletters and web-sites
- Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
Education, Qualifications, Skills and Experience:
- Education in medical or biological sciences or discipline associated with clinical research preferred
- Proven organizational and analytical skills
- Previous administrative training/experience
- Computer proficiency in day-to-day tasks
- Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
- Excellent verbal and written communication in English
- Demonstrate ability to work independently, as well as in a team environment
- Ability to prepare presentation materials
- Demonstrate professionalism and mutual respect
- Willingness and ability to train others on study administration procedures
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
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.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
