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
Not specified
INR 19.0 - 21.0 Lacs P.A.
Work from Office
Full Time
As a Regional Medical Advisor, you will be responsible to engage medical / scientific experts in in-depth medical / scientific product or disease area discussions, and deliver presentations in a non-promotional scientific context as determined by global / local Medical Affairs plans (and in line with the TA and brand strategy). You also act as an educational resource to internal stakeholders, providing medical / scientific knowledge, training, and support to internal stakeholders on AZs marketed products and compounds in development. Key Duties and Accountabilities Develop a strong local KOL network Jointly develop the market/local KOL engagement plan with other MSLs, identify and segment KOLs according to their scientific interest and related affiliations and build the KOL network pre- and post-launch. Engage with KOLs using deep scientific expertise and knowledge of AZs marketed products and compounds in development. Support clinical trials and investigator engagement Provide support to the Global Medicines Development (GMD) team on clinical site identification and patient recruitment for Phase I, II & III studies. Create opportunities to complement existing flow of clinical data for AZs products in line with stakeholder needs, i.e., by identifying pre-clinical, clinical and post-marketing study investigators in alignment with the Development Plan, and engaging in discussions on the ISS Program with potential investigators. Provides support to the internal Global Medicines Development (GMD) team on clinical site identification Engage in scientific exchange Engage with the medical / scientific community in a highly credible, balanced/objective way, representing AZs dedication to and excellence in science Prepare and give relevant high level medical science presentations at congresses, symposia and scientific meetings Provide support for content development, agreeing agendas and delivery of effective clinical presentations e.g., advisory boards Help to develop medical science literature, i.e., write, edit and publish scientific articles and papers Build capability of other internal and external stakeholders Act as a subject matter expert for external clinical / scientific stakeholders Help to build stakeholders understanding about potential solutions to their needs, e.g., extended access programs , approaches to diagnostic testing, etc. Respond to unsolicited stakeholder inquiries and provide focused, balanced and objective clinical / scientific information that supports the safe and appropriate use of AstraZeneca s currently available products, including questions regarding off-label uses, and products under development, when appropriate to do so Act as an educational resource to internal stakeholders Support the sales force and other departments with medical science information (e.g., disease and treatment) and training Effectively gather, analyze , synthesize and forward relevant new knowledge and meaningful insights about the external scientific / medical / regulatory environment to internal colleagues Provide internal stakeholders with actionable items related to brand strategy and GMD based on stakeholders perspectives Review promotional and scientific documents for content accuracy and compliance Be compliant Successfully complete all training requirements, including product examinations and certifications Comply with all external regulations and internal policies Ensure understanding of the AZ Global MSL Guide, AZ Code of Ethics, External Interactions Policy and Standards, and Publications Policy along with relevant local industry codes of conduct. Essential for the role MBBS/MD-Pharmacology Sound knowledge of basic research, drug discovery, drug development, clinical environment Experience in pharmaceutical industry, health care or research environment Proven ability to understand, assimilate and communicate scientific information Proven track record to engage and develop lasting relationships with key thought leaders in complex clinical environments Existing network within the TA ecosystem, with proven ability to influence decision making processes in an ecosystem with multiple influential stakeholders Proven demonstration of successful working in complex cross functional teams Good Planning and Organizational Skills Excellent Scientific knowledge Problem solving and Decision making skills Ability to develop Strategic Partnerships Demonstrate AZ Values consistently Desirable for the role Relevant 1-2 years of experience in Pharma industry Open to look at MD-Pharmacology freshers
Not specified
INR 37.5 - 45.0 Lacs P.A.
Work from Office
Full Time
- Understand attackers, their motivations, and the overall threat landscape. We are potentially working against state-sponsored attacks and multi-billion-dollar organized crime syndicates. - Understand that security is a journey and not a destination. We need to focus on continuous innovation to maintain a balanced risk position against the evolving threat landscape. - Have deep and hands-on knowledge in various domains of cybersecurity. - Have built cyber security solutions which include technology, process, and people. Accountabilities This role will lead a team of engineers and specialists that plan, execute, and sustain the full lifecycle of security solutions. This is a transformational and innovation-driven role. In this role, you ll operate within AstraZeneca s Cybersecurity Products and Assurance group to deliver quality services and solutions that meet both business and IT needs. This is a technical leadership role providing guidance, definition, and design of enterprise-wide security initiatives. You ll collaborate with Business, Solution Delivery, Engineering, and Quality and Compliance functions across a global organization spanning US, UK, Sweden, China, Japan, Poland, Mexico, India, and beyond. - Cyber Security solutions, spanning Cloud, Hybrid and on-premise as well as third-party collaboration environments, including capability models and roadmaps across the Cyber Security function. - Identify and design and deploy cyber security solutions for the organization. - Help influence the future state of cyber security within assigned domains, conduct review and gap analysis. - Create and promote security best practices such as playbooks and standards. - Work with existing security teams to implement and enforce strategies and policies across the enterprise. - Define and create a portfolio of secure design principles. - Collaborate with other technical cyber functions resulting in effective security. - Stay abreast of innovations in the cyber industry and incorporate in solutions. - Keep abreast of industry best practices, vendor capabilities and industry frameworks to sustain a best-in-class program. - Guide and support Architects, Engineering and Support functions to ensure that solutions are secure and align with AZ Security policies and guidelines. - Perform security reviews, leveraging threat modeling and other techniques and influence how solutions can be improved for security in the way they are designed, used, built, and maintained. - Hire, lead, and grow a diverse team, inclusive culture, and collaborative processes that reward behaviors in addition to delivery. - Provide technical leadership and guidance to both your team members, peers, and other leaders in the organization. Essential Skills/Experience - Must have an in-depth understanding of the key cybersecurity frameworks, controls, and best practices. - Experience and technical understanding of leading cybersecurity vendor solutions across the OSI layers. - Must have experience in problem-solving, defining requirements, and developing solution blueprints. - Have an excellent understanding and proven capability in Cloud, Hybrid and On-Premise architectures. - Familiarity with common attack techniques and their remediation/defense including DoS, DDoS, Social engineering, Virus, Malware, Vulnerability exploitation, Phishing & Spear Phishing, Worms, Trojans, Rootkits, Ransomware, XSS, SQL Injection, Remote Command Execution, Session Hijacking, etc. - Solid understanding of security protocols, cryptography, authentication, authorization and network security implementations. - Ability to carry out evaluations, gap analysis and vendor assessments for security technologies and applications. - Ability to design, build, test and implement cyber security solutions. - Ability to map governance and compliance frameworks and controls to technical implementation. - Strong Cloud architecture and multiple demonstrated ability. - Ability to prioritize and validate the threats that really matter. - Security roadmap and strategy development. - Able to work across multiple teams spanning many geographic regions. - Excellent written and oral communication skills. - Have or are working towards a recognized Cyber Security certification. - Experience hiring, building, and leading a technical team.
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INR 10.0 - 14.0 Lacs P.A.
Work from Office
Full Time
Represents and manage the interface between Global Regulatory Operations (GRO) delivery units and early as well as late stage drug projects. Collaborates with GRO teams and partners to assure efficient delivery of end to end Regulatory Information Management. Manage and govern the regulatory data for assigned areas of responsibilities in accordance with regulatory data standards, business processes and regulatory requirements. Compiles and delivers XEVMPD, IDMP or other regulatory data submissions to health authorities. Develops self in topic areas critical to successful delivery of the RIM remit. Particularly, technical skills and knowledge of international regulations. Engages with partners, affiliates, or other customers and stakeholders to manage regulatory data and to ensure compliance with procedures and standards. Monitors the environment for changes in legislation related to regulatory information. Reviews and evaluates regulations, guidelines and technical specifications related to regulatory information processes and regulatory information data standards. Subject matter expert in the management, analysis and quality control of regulatory data standards and regulatory information. Essential Skills/Experience: University degree in the life sciences or equivalent experience in pharmaceutical/medical industry Knowledge of pharmaceutical drug development process Strong analytical and critical thinking ability Good understanding of current regulatory legislation, guidelines and trends relating to regulatory information (process, tools, standards) Descried Skills/Experience: Good problem and conflict resolution skills. Ability to set and manage priorities, performance targets and project initiatives. Ability to innovate best practices with business process analysis and design Ability to thrive in a rapid paced environment
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INR 16.0 - 20.0 Lacs P.A.
Work from Office
Full Time
As a CMC RA Reg Manager, you will project manage global CMC regulatory submissions, ensuring that all project activities and documentation meet the required standards throughout the product lifecycle. You will lead and contribute to regulatory CMC components of business-related projects, maintaining effective communication with stakeholders and project team members to ensure timelines and regulatory commitments are met. Your expertise will help apply global CMC regulations and guidance within AstraZeneca, contributing to the development of new policies and processes. Accountabilities Manage the timely preparation (may include authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle, including clinical programs, marketing authorization applications, and post-approval activities. Deliver submission ready CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality. Ensure publishing tools are in place and perform timely publishing of the CMC sections. Lead/represent PT&D and Pharm Sci on cross-functional work streams. Document maintenance and communication of Health Authority approval status. Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions. Adapt to changing situations to ensure on-time delivery through project management expertise. Proactively share learning from own projects with colleagues. Act as Subject Matter Expert (SME) or Sub-Process Owner (SPO) when applicable, advising project teams. Provide advice, training, and mentorship to other team members. Train others in procedures and practices relating to ANGEL within PT&D and Pharm Sci. Raise change requests (ANGEL), manage, escalate, and input into the cross-functional vote. Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence to optimize proposed submission content. Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team. Contribute to business process optimization activities to reduce waste and ensure efficiency. Evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments. Apply GxP principles according to the stage of the product lifecycle. Lead change as assigned. Understand the application of appropriate risk management across own activities. Demonstrate research skills in understanding regulations and mentorship from different regulatory agencies. Conduct activities and interactions consistent with Things We Value and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance. Essential Skills/Experience: Bachelors degree in Science, Regulatory Sciences or Pharmacy Breadth of knowledge of manufacturing, project, technical, and regulatory management IT Skills Partner & Project management Professional capabilities: Regulatory knowledge Desirable Skills/Experience: Masters degree in Science, Regulatory Sciences or Pharmacy Knowledge of the drug development process and regulatory submissions Understanding of current regulatory CMC requirements Direct/indirect Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology-derived products such as monoclonal antibodies or sophisticated biologic products Understanding of regulations and mentorship governing the manufacture of biotechnology products, especially monoclonal antibodies Lean capabilities
Not specified
INR 9.0 - 14.0 Lacs P.A.
Work from Office
Full Time
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company s core therapeutic areas in all phases of clinical development. Our vision is to be an industry-leading organization driving essential communication excellence to achieve successful submissions and approvals. The Clinical Regulatory Writing Manager is expected to: With limited guidance, lead author and ensure the timely delivery of high-quality clinical-regulatory documents. Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and standard methodology are applied. Have the ability to balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities. Drive the clinical interpretation of data and information and condense it into clear, concise and accurate messages that address customer information requirements. Provide critical review of documents for correctness, clarity, completeness and compliance. Proactively collaborate with other functions during document development, including, as needed, with external service providers/contractors. As part of a clinical delivery team, provide communications support to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency. Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Clinical Regulatory Writing on drug and non-drug projects, as required. Work independently but with the guidance and support of more senior members of the group. Essential Skills/Experience Life Sciences degree in an appropriate subject area. Experience in medical communications. Strong communication and leadership skills. Knowledge of the technical and regulatory requirements related to the role. Desirable Skills/Experience Advanced degree in a scientific discipline (Ph.D). Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.
Not specified
INR 15.0 - 17.0 Lacs P.A.
Work from Office
Full Time
Your work will include generating Tables, Listings, and Figures (TLFs) for analysis purposes. You will ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. Supporting the Programming Lead, you may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams. Additionally, you will mentor Statistical Programmers and external consulting resources, demonstrating a strong ability to integrate statistical concepts with SAS Programming efficiently and effectively. Independence is crucial in this role. Accountabilities Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience Minimum of 4 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members High competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Knowledge and implementation of: SDTM and ADaM principles Relational Databases Good Clinical Practice principles Good Programming Practice principles 21CFR Part 11 Standards principles Integrated Summary Safety/Efficacy Analyses Safety data and Coding Dictionaries (MedDRA and WHODD) ICH eCTD format Integrated Summary Safety/Efficacy Analyses Desirable Skills/Experience Safety data and Coding Dictionaries (MedDRA and WHODD) ICH eCTD format
Not specified
INR 15.0 - 17.0 Lacs P.A.
Work from Office
Full Time
Your work will include generating Tables, Listings, and Figures (TLFs) for analysis purposes. You will ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. Supporting the Programming Lead, you may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams. Additionally, you will mentor Statistical Programmers and external consulting resources, demonstrating a strong ability to integrate statistical concepts with SAS Programming efficiently and effectively. Independence is crucial in this role. Accountabilities Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience Minimum of 4 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members High competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Knowledge and implementation of: SDTM and ADaM principles Relational Databases Good Clinical Practice principles Good Programming Practice principles 21CFR Part 11 Standards principles Integrated Summary Safety/Efficacy Analyses Safety data and Coding Dictionaries (MedDRA and WHODD) ICH eCTD format Integrated Summary Safety/Efficacy Analyses Desirable Skills/Experience Safety data and Coding Dictionaries (MedDRA and WHODD) ICH eCTD format
Not specified
INR 9.0 - 14.0 Lacs P.A.
Work from Office
Full Time
Overall 6+ years of development experience with a minimum of 4+ years of Salesforce Development experience Experience in Salesforce Service Cloud implementations and communities Salesforce Development/Customizations, Lightning Components experience Design and implement solutions leveraging Salesforce out-of-box features Excellent problem-solving and analytical skills Design and improve internal development methodologies Propose technology solutions to enable the business to meet/exceed those goals Analyze business requirements and create technical design documents that are in accordance with the companys architecture standards Demonstrates strong understanding of the business needs driving the projects Essential Skills/Experience: Salesforce Service Cloud implementations and communities Experience of taking business requirements and designing solutions Excellent problem-solving and analytical skills Familiarity with modern development practices and the software development life cycle Excellent communication and organizational skills Ability to manage multiple priorities, meet deadlines, and produce quality results under pressure Master s / Bachelor s degree or equivalent
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INR 8.0 - 12.0 Lacs P.A.
Work from Office
Full Time
Working within the People Services function, Senior Advisors will provide specialist guidance and coaching to managers and HR colleagues on all HR policies, processes, and programs. You may also have specialist knowledge in a particular Human Resources functional area or country/market. Activities are handled rather than supervised, with the immediate manager providing guidance as required. You are likely to have a professional Human Resources qualification and may supervise or manage a team of Administrators or Advisors. You may also be a member of a pool of Human Resources professionals working on diverse Human Resources/Business projects. Accountabilities Working within the People Services function, you will deliver generalist support, acting as the tier 2 contact for provision of professional advice and support to a range of activities and programs. Own delivery for one or more service lines or country/market. Operate independently, calling out only the most complex issues. Act as a specialist supporting employees, managers, and HR colleagues (centralized and offshore) with complex data transactions or queries. Work with HRBPs to support business leaders and line managers in annual people processes, understanding business priorities, and supporting local requirements within global standards. Provide Tier 2 level advice on a range of employee-related matters covering one or more service lines e.g., Advisory & Guidance, WFA, Taq, and escalate within People Services or COEs as appropriate. Provide support for business change based on strategic guidance and direction by HR Business Partners and business leaders. Review HR policies and processes, identifying areas for improvement and making recommendations for change. Support required training delivery for local populations. Drive Manager/Employee adoption of the Operating Model, coaching customers to use the right channels and HR teams to receive the support they need. Essential Skills/Experience HR generalist experience Strong written and verbal communication skills Ability to influence leaders with gravitas to act as trusted advisor Ability to work collaboratively with large teams Desirable Skills/Experience CIPD qualified HR/business-related degree Strong commercial awareness Experience of working in a multi-national organization
Not specified
INR 4.0 - 6.0 Lacs P.A.
Work from Office
Full Time
The Senior Scientist will apply scientific domain-specific knowledge (in bioinformatics) and/or clinical disease area expertise , specialized data processing techniques, analytical and machine learning capabilities to extract scientific insight and hypotheses from data. The role will work in partnership with scientists and clinicians to support the generation of innovative solutions, within defined project scope and aligned to established frameworks, which support decision-making in pre-clinical, development and post-market activities. Introduction to role: Join AstraZeneca, a pioneering bio-pharmaceutical company thats not afraid to do things differently. Were seeking a highly skilled Bioinformatics researcher with a strong desire to enable multi-omics biology in drug discovery and development. Youll be part of our Predictive AI & Data department within the Clinical Pharmacology and Safety Sciences (CPSS) function. This is a unique opportunity to work with industry leaders, contribute to the development of future drugs across many diseases, and grow beyond what you thought possible. Accountabilities: As a Senior Scientist Bioinformatics, you will build predictiveAI capabilities that make use of multi-omics technologies that measure transcript s or genome variants to discover novel mechanisms of action for our compounds and/or therapies . You will drive hypothesis generation by applying computational biology approaches, data integration, and combining biological knowledge. You will also implement new predictive capabilities using computational biology to translate omics data into biological insights. Collaboration with academic research groups and contribution to publications in peer-reviewed journals will be part of your role. You will also help educate and train AstraZeneca colleagues in omics data interpretation and related areas, and co-ordinate and liaise with external suppliers of bioinformatics capabilities to deliver on urgent projects and developing capabilities. Essential Skills / Experience : PhD in computational ( bio ) sciences (e.g., computational biology, bioinformatics, genomics , transcriptomics or computer science) is preferred; or MSc (or equivalent) with experience in independent research in high-throughput omics data will also be considered Demonstrated experience in ML or DL algorithms and predictive modeling applied to biological or biomedical problems . Demonstrated experience in genomics or transcriptomics data analysis. Skill-sets in additional computational biology domains are a plus. Good applied knowledge of statistics (e.g., parametric and non-parametric tests, p-values, correlation metrics, PCA) and good experimental design practices (e.g., batch effects, confounding factors) Demonstrated expertise in R and Python . Team player mindset and ability to explain complex topics to scientists from other disciplines Ability to communicate effectively (written and spoken) in English Experience in independent scientific research Knowledge of molecular mechanisms of disease or human biomedicine, particularly in a drug safety context Excellent ability to work on multiple projects at the same time Knowledge of drug discovery or pharmaceutical development
Not specified
INR 19.0 - 21.0 Lacs P.A.
Work from Office
Full Time
We are seeking an experienced and creative Senior Graphic Designer to produce and oversee digital and print creative solutions to address our marketing needs. The designer s responsibilities will include defining project requirements, developing design elements, and building final deliverable assets. The ideal candidate will need to have a strong portfolio, advanced design skills, and the ability to lead design projects from concept to completion. Accountabilities Strong experience in Adobe Creative Cloud tools such as Adobe InDesign, Photoshop, Illustrator, XD, MS PowerPoint, and Figma. Ability to appreciate brand values and lead and manage design projects from initial concept to final delivery. Create original designs, including illustrations and infographics. Evaluate the work of junior designers to ensure it meets quality standards. Enhance images, fonts, and layouts using graphic design software. Apply advanced typography techniques. Maintain consistency with visual communication and brand standards. Mentor and support junior designers in their professional growth. Handle multiple projects simultaneously and meet tight deadlines. Work with other departments to align design efforts with overall business objectives. Build and maintain relationships with clients and collaborators. Contribute strategic insights for marketing and branding initiatives. Keep up to date with the latest graphic design techniques, graphic fundamentals, typography, and a good understanding of colors. Ability to work with abstract requirements and come up with clear concepts and appealing visual designs & presentations. Work on digital media designs and infographics creating highly impactful marketing campaigns. Ability to effectively communicate & collaborate with the team. Essential Skills/Experience In-depth knowledge of graphic design, styles, and layout techniques. Proven experience executing marketing projects from conception to production, including websites, brochures, product packaging, and corporate identity. Strong communication and presentation skills. Ability to manage ambiguity and be proactive. High integrity and commitment to work in a new and challenging environment. Ability to work independently and produce quality/innovative deliverables with minimal supervision. Leadership skills and experience in mentoring junior designers. Excellent time management and organizational skills. Ability to develop and maintain client relationships. Strong critical thinking and problem-solving skills. Ability to solve design challenges and provide creative solutions. Keen eye for detail and precision in design work.
Not specified
INR 22.5 - 30.0 Lacs P.A.
Work from Office
Full Time
The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format. Additionally, strong people management and supervisory skills are essential to provide direct line management to statistical programmers, identify training needs, and optimize staff utilization. The role also involves managing the day-to-day activities of external partners in delivering program deliverables. Accountabilities - Serve as the Lead Programmer and Manager of the statistical programming efforts. - Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. - Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. - Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs. - Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications. - Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. - Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. - Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary. - Create and/or review programming plans, and ensure appropriate resource allocation and prioritization. - Act as the primary department contact to ensure that department standards are implemented in all studies. - Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards. - Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support. Essential Skills/Experience - 7+ years statistical programming experience in the CRO or Pharmaceutical Industry. - 4+ years project management experience in the CRO or Pharmaceutical Industry. - Experience with CDISC SDTM and ADaM models and transforming raw data into those standards. - Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion. - Strong verbal and written communication skills - ability to clearly and effectively present information. - An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance. - Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures. - Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs. - Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle. - Advanced experience with: - Constructing technical programming specifications. - Relational Databases. - Good Clinical Practices. - Good Programming Practices. - 21CFR Part 11 Standards. - Integrated Summary Safety/Efficacy Analyses. - Creating all files necessary to support an electronic submission in the eCTD format. Desirable Skills/Experience - BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area. - Competencies: - Accountability - Collaboration - Decision Quality - Drive for Results - Perseverance - Problem Solving - Informing - Peer Relationships - Time Management - Building Effective Teams - Managing Through Systems
Not specified
INR 14.0 - 18.0 Lacs P.A.
Work from Office
Full Time
The person carrying this role will play a key part in the design, development, and maintenance of analytics and reporting solutions in support of the Global Regulatory business. The role will focus on tactical and operational activities, ensuring the effective delivery of data-driven insights that enhance regulatory compliance and data quality. This role requires a strong technical background in data analysis, data design, visualization, and reporting tools and frameworks, as well as the ability to collaborate effectively with cross-functional teams to deliver high-value-adding solutions to the business. Accountabilities Collaborate with senior team members and cross-functional teams to assist in the design, development, and testing of analytics and reporting solutions to meet business requirements. Contribute to the identification, gathering, and analysis of data from various data domains and sources to support regulatory submissions and compliance activities. Assist in the development and maintenance of data models, dashboards, and reports to provide actionable insights for regulatory decision-making, process compliance, trend analysis, and performance monitoring. Work closely with Senior Developers and Technical Lead to ensure the technical solutions align with team objectives and strategic plans, including leveraging the use of AI/ML and Automation. Assist in developing and maintaining technical and business documentation, including GxP documentation and training materials. Learn from and contribute to the mentorship provided by senior team members. Contribute to team performance monitoring, objectives planning, and tactical planning under the guidance of senior team members. Essential Skills/Experience Bachelor s degree in data science, computer science, information systems or related field Strong proficiency in data analysis, data quality and visualization tools such as Power BI, Power Automate, Snowflake, Aperture, Oracle or similar platforms. Expertise in SQL, Python, VBA or other programming languages commonly used in data analysis. Strong problem-solving and analytical skills with a keen attention to detail with a willingness to learn and grow in a technical role Desirable Skills/Experience Familiarity with Regulatory requirements and processes in the pharmaceutical or biotech industry. Experience with cloud-based data platforms (e.g., AWS, Azure, Accumulus) and big data technologies. Knowledge of best practices in software development life cycle (SDLC) and Agile methodologies.
Not specified
INR 9.0 - 14.0 Lacs P.A.
Work from Office
Full Time
As a Workday Consultant, you will work with HR and other HR IT consultants designing, developing, and implementing integrations to ensure internal and external systems are aligned. This is an exciting opportunity to be at the forefront of projects and enhancements of our HR Information Systems Accountabilities: - Focus on delivering integration and Extend solutions within Workday. This includes collaborating with other IT teams in AstraZeneca (Identity Management, MuleSoft, etc.) and our vendors IT Teams. - Understand and analyze business requirements to determine Extend and integration solutions across various types of tools and technologies; documentation of requirements, solutions and impacts, alternatives, and final decisions. - Participate in discovery sessions or workshops with our partners in Human Resources across multiple Centers of Excellence. - Work in a team environment, coordinating with teammates, Global Process Owners, and members of HR. - Understand and comply with AstraZeneca s change and release methodology. - Provide status reports to your Engagement Manager, technical lead, or supervisor, keeping them apprised of the overall project situation. Essential Skills/Experience: - Strong consulting and presentation skills with the ability to effectively manage customer expectations. - Desire and willingness to learn new tools, techniques, concepts, and methodologies. - Strong analytical mindset and usage of analytics and reporting tools. - Ability to learn technology quickly through instruction and self-training. - Familiarity with HR systems and technologies (e.g., HRIS, ATS, LMS), with the ability to evaluate and recommend suitable solutions. - Integration and Extend Expertise - EIB, Studio, CCW, CCB, Payroll Integrations, Extend, Knowledge on using API. - Knowledge of Web service-related topics (REST, JSON, SOAP, HTTP, SSL, PGP, SAML, OAuth, etc.). - Experience with XML/XSLT and Java will be helpful. - Experience in Workday reporting tools. - Experience in Extend and creating detailed system integration specifications, field mapping, and system process designs. - Experience with the various technologies involved in SOA development (XML, XPath, XSLT, Web Services, etc.). - Experience with the full lifecycle of both Workday implementations and upgrades. - Experience in providing Workday Support. - Ability to work creatively and analytically, prioritizing problem-solving. - Clear and Effective communication. - Effective analytical skills.
Not specified
INR 14.0 - 19.0 Lacs P.A.
Work from Office
Full Time
What you ll do Support the definition, documentation and implementation of S/4 Enterprise Data standards related to NSSCP, including master data, reference data and metadata - collecting the business context and ensuring approval in accordance with defined data governance. To include the development of conceptual models, business glossary and ontologies. Lead and support on S4 and OMP integration activities within the programme. Apply data, process and object expertise to support S/4 process design, acting as an integral part of the NSSCP design team, considering both business process and analytics requirements. Collaborates with current business data capability to ensure that S/4 design and the wider enterprise data design remain aligned (including supporting interim state). Influence in the prioritisation of data delivery as related to NSSCP defining and managing reporting on progress to relevant stakeholders. Supports with the definition of the change journey from current to future state data design including completion of change impact assessments and outline of critical use case examples. Ensure that non-SAP system requirements are understood and considered in the data design. Contribute to the development of the S/4 and OMP Data Governance Strategy and Roadmap, in collaboration with the business data offices, the S/4 Data Analytics leadership team and wider project delivery engine where relevant. Assist in the development of the S/4 Data Quality Strategy and secure its execution through the steering and agreeing the data quality approach for data within NSSCP enabling simplified migration, interim state, and the ongoing management of data to ensure that it remains fit for purpose post deployment. Contribute to the development of the S/4 Cleanse and Migrate strategy and execution approaches and plans. Input to the cleanse and enrichment approach for data within NSSCP in accordance with the overall data cleanse strategy. Provide support to project data migration processes, including the co-ordination of pre and post load business sign off. Ensure that data within NSSCP complies with the S/4 HANA Data Governance Framework and AZ Global Data Standards. Assist the S/4 Data Governance team in the creation of effective global procedures to ensure that each data asset is governed throughout its lifecycle. Essential for the role Significant experience and subject matter expertise in Planning/NSSCP. Demonstrable knowledge of how business data requirements support process execution and analytics, with the ability to explain complex data concepts to business users. Demonstrable experience of designing and implementing Data Standards for a global enterprise with significant geographical and functional footprint. SAP and OMP working knowledge across transactions including an understanding of how data integrates within an SAP architecture. Experience of Business/IT partnering for the implementation of Data Governance-related solutions. Experience with global working and across cultures. Demonstrate strong communication skills with the ability to influence others to achieve objectives Ability to manage negotiations across a complex group, to a target outcome. Proven track record of delivery and ability to effectively prioritise to ensure goals and outcomes are achieved Desirable for the role S/4 HANA implementation programme experience. Experience in OMP. Experience in life sciences and healthcare. Experience in Data Governance Experience in measuring, managing and improving Data Quality. In depth knowledge of relevant key business processes
Not specified
INR 32.5 - 40.0 Lacs P.A.
Work from Office
Full Time
Accountabilities 1. Dedicated Accountability: Embrace and drive a culture of accountability for customer and business outcomes. Develop solutions that tackle sophisticated HR Site Operation problems with valuable outcomes, ensuring high-quality, lean designs and implementations. 2. Technical Leadership and Advocacy: Serve as the technical advocate for ServiceNow HRSD WSD solutions, ensuring architectural integrity, feasibility, and alignment with business and customer goals, NFRs, and applicable architecture and engineering standards being responsible for solution architecture blueprints, high-level architecture designs, and integration architecture into the technical landscape and technology stack. 3. Engineering Craftsmanship: Possess passion and experience as an individual contributor, responsible for the engineering designs and technical feasibility of solutions, being hands-on with design as well as configuration part of the time, contributing to team velocity. Actively engage with engineers to ensure architecture is understood and can be implemented, working with them closely during sprints, helping resolve any technical issues through to production operations: reviewing implementations, actively driving technology debt reduction, and helping drive engineering quality. Be dedicated to learn new technologies, experiment with engineers, and inspire the team to learn and drive application of those new technologies. 4. Customer-Centric Engineering: Develop lean engineering solutions through rapid, inexpensive experimentation to tackle customer needs. Engage with customers and product teams to deliver the right architectural solution in the right way at the right time. 5. Incremental and Iterative Delivery: Exhibit an attitude that favors action and evidence over extensive planning. Apply a leaning-forward approach to navigate complexity and uncertainty, delivering lean, supportable, and maintainable solutions. 6. multi-functional Collaboration and Integration: Work collaboratively with empowered, multi-functional teams including product management, experience, delivery, infrastructure, and security. Integrate diverse perspectives to make well-informed decisions that balance feasibility, viability, usability, and value. Foster a collaborative environment that enhances team alignment and innovation. 7. Sophisticated Technical Proficiency: Possess deep expertise in modern software engineering practices and principles, including OOD/OOP, Agile methodologies, DevSecOps, Continuous Integration/Continuous Deployment. Act as a Role-Model, bringing to bear these techniques to optimize solutioning and product delivery, ensuring high-quality outcomes with minimal waShow skilliency in ServiceNow HRSD WSD implementation, from conceptualization and design to implementation and scaling, with a focus on continuous improvement and learning. 8. Domain Expertise: Quickly acquire domain-specific knowledge relevant to the business or implemented ServiceNow modules. Translate business/user needs and UX/UI designs into technical requirements and designs. Navigate various enterprise functions such as business and enabling areas as well as product, experience, delivery, infrastructure, and security to drive product value and feasibility as well as alignment with organizational goals. 9. Effective Communication and Influence: Exhibit exceptional communication skills, capable of articulating sophisticated technical concepts clearly and compellingly. Inspire and influence collaborators at all levels through well-structured arguments and trade-offs supported by evidence, evaluations, and research. Create coherent narratives that align technical solutions with business objectives. 10. Engagement and Collaborative Co-Creation: Engage and collaborate with collaborators at all organizational levels, from team members to senior executives. Build and maintain constructive relationships, fostering a culture of co-creation and shared momentum towards achieving product goals. Essential Skills/Experience ServiceNow Knowledge: Familiarity with ServiceNow, especially in Human Resource Service Delivery (HRSD) and Workplace Service Delivery (WSD), is required. You have a confident manner towards customers and demonstrable practical experience in the independent implementation of customer workshops and in requirements management Consultative Approach: Strong problem-solving skills with the ability to think strategically and drive sophisticated projects from feasibility to completion Collaborator Management: Excellent communication skills with the ability to engage and influence collaborators at all levels (also communicate technical concepts to non-technical audiences) User Experience: Ability to deliver solutions that provide best in class user experience with a focus on ease of use, logical process flows, accessibility and productivity Analytical Skills: Experience in analyzing business processes, creating workflow diagrams, and documenting requirements in a clear and concise manner Required Certifications: Certified ServiceNow Technical Master Architect, ServiceNow Implementation Specialist - HR Service Delivery (HRSD) ServiceNow Certified System Administrator. Leadership: Ability to influence senior leaders and collaborators, providing clear recommendations that address business and technical challenges in Human Resource Site Operations service delivery contexts Technical Skills: Proficiency in creating architectural designs, solution presentations, and integration strategies, particularly within Employee Workflow environments. Experience with Web Technologies (XML, HTML, JavaScript, Web Services, Bootstrap, CSS Desirable Skills/Experience Typically, a ServiceNow Employee Workflow Solution Architect would have 8+ years of experience in ServiceNow HRSD WSD solutioning and ServiceNow administration, with an overall experience of 10+ years. As part of the experience is also in leveraging or critically thinking about how to integrate AI into work processes, decision-making, or problem-solving. This may include using AI-powered tools, automating workflows, analyzing AI-driven insights, or exploring AI.
Not specified
INR 10.0 - 11.0 Lacs P.A.
Work from Office
Full Time
You will be responsible to positively influence customers prescribing behavior to achieve sales targets, develop territory and build strong customer relationships with the objective of maximizing sales volume and market share of designated products on a given territory. What you ll do As a Key Accounts Manager, you will be responsible to develop and implement market positioning strategies for the RI products of AZ along with contributing to build the knowledge and capabilities of HCPs at a local level. You will work closely with the sales team to deliver timely sales targets and ensure to create robust stakeholder relationships. Key Duties and Accountabilities Develop account strategy and plans Identify opportunities and strategies to improve positioning of AZ's RI products at a local level. Work with Sales Manager to develop a local strategy and business plan to meet targets and further improve positioning of AZ's RI products at a local level. Create deep stakeholder relationships Engage RI HCPs in dialogue about approved indications, product efficacy / safety profiles and treatment protocols to support on-label prescribing for appropriate patients. Establish and maintain ongoing, long term collaborative relationships with stakeholders. Share stakeholder insight and information within AZ to strengthen relevant activities, e.g., product development, marketing, sales efforts. Build capability and knowledge in healthcare eco-system Build knowledge and understanding about AZ's overall RI value proposition, and product's labeled indications and efficacy data among all relevant stakeholders in the MDT and DMU. Utilize different communication approaches, techniques, and channels to help build knowledge in the MDT and DMU, including. Conduct science-based discussions with the HCP as per the approved indications of AZ's products. Arrange multidisciplinary workshops for physicians and other healthcare professionals. Arrange and coordinate effective speaker programmes with physician advocates and KOLs. Actively support RI nurses on relevant trainings, e.g., chemotherapy, testing solutions. Deliver on plans and achieve sales goals on budget Drive sales performance and ensure sales forecasts meet or exceed expectations while managing assigned budgets. Successfully promote the benefits of AZ's RI brands, using fair balance messages and the appropriate mix of promotional tools. Ensure AZ's products are optimally utilized in line with national/local guidelines and the product license. Be compliant Successfully complete all training requirements, including product examinations. Comply with all external regulations and internal policies. Ensure compliance with the AZ Code of Ethics, Global External Interactions Policy and Standards, and Privacy Policy and Standards, especially when interacting with Patient Groups. Essential for the role University Science graduate, ideally MBA from reputable institute. Proficient in oral and written communication (English). Must have 3+ years of sales experience with Pharma sector in RI domain. Should have been a high performer in sales, Cross functional engagement, strong business acumen. Organizational skills, good analytical skills / mind set, ability to manage complexity with a high degree of maturity.
Not specified
INR 50.0 - 85.0 Lacs P.A.
Work from Office
Full Time
Accountabilities: Supervise a team within the Patient Safety Technical Solutions organization, ensuring high-quality expertise and services across the pharmacovigilance compliance systems estate. Drive a performance-focused culture within the team by supporting ongoing development of expertise, leadership, and talent. Provide global expertise in respect of the Company s core pharmacovigilance compliance systems. Lead applicable tools and methodologies to ensure processes and systems fully address stakeholder needs. Ensure system ownership of PS systems, inclusive of relevant system processes. Support ongoing business utilization of PS systems, including troubleshooting problems and developing solutions. Provide technical guidance on the development of strategic plans for PS systems across the enterprise. Evaluate new modules and software upgrades and assess their impact on system validation, user community, and PV processes. Ensure compliance with global and local procedural documents and local implementation of Global Patient Safety objectives, policies, processes, and procedures. Participate in interactions with licensing partners and health authorities on electronic safety data exchange. Support as required in the license partner/CRO pharmacovigilance agreement (PVA) process. Manage team resources and deliver effective service to Global Patient Safety and the enterprise. Proactively manage supply/demand forecasts for their area and prioritize workload to meet business demand. Essential Skills/Experience: Bachelor s degree in a scientific field, with relevant experience in supporting safety-related activities in the context of clinical biopharmaceutical development. Significant experience (12+ years) in pharmacovigilance with a proven record of supporting safety tools/solutions. Proven competence with extensive involvement in the successful design, delivery, deployment, or maintenance of information/systems solutions in support of safety. Broad knowledge of the safety information tools required to support drug development and marketed brands within AstraZeneca. Ability to articulate complex safety-related business needs in the context of IS systems design, architecture, and development. Business awareness of wider IS developments within AZ or the pharmaceutical industry. Significant experience in system validation, audit, and PV inspection activities and requirements. Desirable Skills/Experience: Higher degree or equivalent experience in a clinical or safety-related field. Demonstrable leadership skills with experience in line-managing diverse groups of experts. Key capabilities commensurate with the Global Career Level of the role (e.g., Leadership Capabilities). Ability to find opportunities to lead change through continuous improvement based on strong awareness of external competitive practice. Experience across multiple therapeutic or business areas or working in safety-related roles within other biopharmaceutical, regulatory, or health organizations. Knowledge of procedures, processes, and standards governing clinical trial data with health authorities worldwide. Excellent interpersonal skills to influence/shape their team and understand multiple complex business needs.
Not specified
INR 27.5 - 34.0 Lacs P.A.
Work from Office
Full Time
Responsible for medical/clinical components of periodic reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Developmental Safety Update Reports (DSURs), and annual New Drug Application (NDA) reports, license renewals, labeling, and regulatory responses (in collaboration with other team members) under the direction of the Global Clinical Leader (GCL) or delegate Senior Medical Lead (SML) Participate and provide inputs in safety review meetings as required Work with international colleagues and external Alliance partners on development initiatives and regulatory issues Apply strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers, and consumers of AstraZeneca products Serve as a source of medical expertise for the Product Team Provide guidance for investigator-initiated trials in cooperation with regional marketing companies Act as Global Clinical Leader delegate on assigned tasks Accountable to GCL (or delegate) and Clinical leadership for identifying risks and proposing mitigation strategies to enable successful execution of License-to-Operate tactics Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws Accountable to GCL (or delegate) and Clinical leadership for identifying risks and proposing mitigation strategies to deliver successful Phase III or LCM studies Other Activities: Participate in external regulatory and non-regulatory meetings including those with consultants and other companies such as licensing partners Contribute to the advancement of methodology and process by generating new ideas and proposals for implementation Raise concerns/issues to senior management in a timely, open, and appropriate manner; ensure quality and integrity of issue/event being escalated Collaborate effectively in cross-functional and cross-cultural project teams and environments, and work with external providers Essential Skills/Experience: Graduate of a recognized school of medicine with an M.B.B.S./M.D. degree or equivalent At least 2 years of clinical experience post-registration 7+ years clinical research expertise in relevant therapy area or CRO experience High level of medical competence, with an ability to balance this with industry standards to achieve business goals Fluent in oral and written English Proven teamwork and collaboration skills Good presentation skills. Can communicate effectively with internal and external collaborators Desirable Skills/Experience: Able to work across TAs and Functions A demonstrated ability to understand epidemiological data Ability to review literature and identification of safety and efficacy data Benefit-risk assessment Specialty training in cardiology or endocrinology At AstraZeneca, we are driven by a shared purpose to push the boundaries of science to deliver life-changing medicines. Our collaborative culture fosters innovation and creativity, empowering you to make a real difference in patients lives. With access to cutting-edge technology and a diverse pipeline, youll have the opportunity to work on groundbreaking projects that address some of the most complex unmet medical needs
Not specified
INR 22.5 - 27.5 Lacs P.A.
Work from Office
Full Time
Perform all surveillance activities including periodic report production, leading monthly signal-detection activities, and SIRC activities for established products. Author/provide strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Produce high-quality and timely responses to safety queries. Identify and use appropriate sources of information and database searches to retrieve relevant data for evaluation of signals for all products in your area of responsibility. Foster a culture devoted to growth and achievement. Raise appropriate concerns/issues to senior staff in a timely manner. Lead the Safety Strategy and Management Team (SSaMT) for established products. Perform end-to-end pharmacovigilance activities independently on established products. Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures. Provide strategic and scientific input into regulatory authority submissions, queries, and discussions. Support responses to queries/impositions by regulators, with a high level of attention to implications in other countries. Ensure good communication and guidance to AZ products. Essential Skills/Experience Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety (pharmacovigilance)/clinical development. Comprehensive understanding of applicable Patient Safety regulatory obligations in the EU. Awareness of Patient Safety policies, processes, and procedures. Awareness of medico-legal aspects of patient safety. 4 to 7 years of Patient Safety experience (with clear evidence of delivery). Total of 7 to 10 years of experience. Desirable Skills/Experience Ability to work effectively as a member of a cross-functional or distributed team. Ability to work with autonomy. Ability to acquire and assimilate knowledge in different fields, disease, and therapeutic areas. Good communication skills with the ability to work across cultures. High ethical standards, including a commitment to AstraZeneca values and behaviors. Ability to appreciate diversity and work as equals with global and cross-functional teams. Communication: Well-developed interpersonal skills. Cultural sensitivity. Ability to network with other functions globally
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