2346 Life Sciences Jobs - Page 9

Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives . Manage the quality assurance oversight of projects, assignments, training and staff. Essential Functions Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies. Oversee and participate in the documentation, reporting, and closure of compliance issues. Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified. Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. Serve as author of Quality Assurance Standard Operating Procedures ( SOPs) as assigned. Advise Quality Assurance management on system audit needs. Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status. Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed Qualifications Bachelors Degree Pref 7 years Quality Assurance experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience. Knowledge of word-processing, spreadsheet, and database applications. Extensive knowledge of pharmaceutical research and development processes and regulatory environments. Considerable knowledge of quality assurance processes and procedures. Strong interpersonal skills. Excellent problem solving, risk analysis and negotiation skills. Exceptional training capabilities. Effective organization, communication, team orientation, and leadership skills. Ability to work independently with initiative. Ability to manage multiple projects. Ability to establish and maintain effective working relationships with coworkers, managers and clients

Bring more to life. Are you'ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Pall Corporation, one of Danaher s 15+ operating companies, our work saves lives and we're all united by a shared commitment to innovate for tangible impact. you'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety and environmentally responsible technologies. From airplane engines to hydraulic systems, scotch to smartphones, OLED screens to paper everyday Pall is there, helping protect critical operating assets, improve product quality, minimize emissions and waste, and safeguard health. For the exponentially curious, Pall is a place where you can thrive and amplify your impact on the world. Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation. Learn about the Danaher Business System which makes everything possible. The Associate Analyst is responsible for supporting the organizations IT infrastructure by assisting with vulnerability management and providing IT support. This role involves helping to identify vulnerabilities within systems, aiding in their mitigation, and offering technical support to ensure smooth business operations. The ideal candidate will have basic problem-solving skills and a willingness to learn and develop a proactive approach to vulnerability management. This position reports to the Senior Manager, Configuration & Vulnerability Management, is part of the Information Technology Team, and will be located onsite in Kuala Lumpur, Malaysia. In this role you will have the opportunity to: Assist with regular vulnerability assessments to identify weaknesses within the organizations IT infrastructure. Help with patch management and the deployment of updates for desktops, laptops, servers, and applications. Participate in the continuous improvement process by supporting the timely deployment of patches for Windows and third-party applications. Enhance user experience by addressing technical challenges and finding opportunities for improvement. Stay informed about emerging vulnerabilities and provide proactive recommendations for remediation. Contribute to innovation by identifying and implementing new technologies and processes that enhance customer satisfaction and support Palls long-term success. The essential requirements of the job include: Basic knowledge of vulnerability assessment and patch management tools (eg, CrowdStrike, SCCM, Microsoft Intune Admin Center). Familiarity with Microsoft Endpoint Configuration Manager (SCCM), Azure, Entra, and Intune. Passionate about fostering a culture of continuous improvement, elevating the customer experience, and ensuring operational excellence. A team player with a positive attitude and willingness to provide and receive constructive feedback. A keen interest in learning about new technologies and systems and staying up to date with industry trends. It would be a plus if you also have: Good presentation skills for explaining technical concepts to technical and non-technical stakeholders Industry experience in diverse environments such as manufacturing, finance, healthcare, or government sectors. Understanding analytics and machine learning for threat detection and vulnerability assessment. Pall Corporation, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site. Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Consulting to FAR team in case of any filed alert expected (as applicable). About you: Experience: 3 7 years of related experience in the pharmaceutical industry. Knowledge of cGMP s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: bachelors or Masters in Life Sciences/Healthcare, Business Administration, Engineering. Languages: Verbal and written fluency in English Why choose us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, we'll-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and we'llbeing benefits including high-quality healthcare, prevention, and we'llness programs and at least 14 weeks gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowe'red to propose and implement innovative ideas.

Will implement marketing strategies&campaigns for product promotion to doctors, effective in-clinic presentation to doctors, identifying & promoting right product for right doctors, retail chemist prescription audit, timely reporting&achieve targets Required Candidate profile Preferably D. Pharm, B.Sc having 1-3 year exp. in pharma ethical selling having high energy level, effective communication / presentation / convincing skills and proven track record of achievements

2. In depth knowledge of Indian / Global (EU, US and TGA) pharmacovigilance guidelines / regulations 3. Strong knowledge and understanding of medical terminology and clinical development processes Required Candidate profile Educational qualification Graduation/post-graduation in Pharma, science or any life science Function/department Pharmacovigilance only accepted who has worked in pharma company in this function

1.To perform cleaning of Visual inspection equipment in fill finish facility. 2.To Perform visual inspection of Vials, PFS and Cartridge along with documentation. 3.Making entries in log books, batch packing record and status labeling. Required Candidate profile 1. Looking for smart and dynamic pharma fresher candidate. 2. Candidate should be very good in to written and oral english communication 3. Candidate should be very dynamic.

Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsYou will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures The person requires understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor or team leads Generally interacts with peers and/or management levels at a client and/or within Accenture The person should require minimal guidance when determining methods and procedures on new assignments Decisions often impact the team in which they reside and occasionally impact other teams Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Interested can also apply with Sanjeevan Natarajan - 94866 21923 sanjeevan.natarajan@careernet.in Role & responsibilities Technical Leadership Lead a team of data engineers and developers; define technical strategy, best practices, and architecture for data platforms. End-to-End Solution Ownership Architect, develop, and manage scalable, secure, and high-performing data solutions on AWS and Databricks. Data Pipeline Strategy Oversee the design and development of robust data pipelines for ingestion, transformation, and storage of large-scale datasets. Data Governance & Quality Enforce data validation, lineage, and quality checks across the data lifecycle. Define standards for metadata, cataloging, and governance. Orchestration & Automation Design automated workflows using Airflow, Databricks Jobs/APIs, and other orchestration tools for end-to-end data operations. Cloud Cost & Performance Optimization Implement performance tuning strategies, cost optimization best practices, and efficient cluster configurations on AWS/Databricks. Security & Compliance Define and enforce data security standards, IAM policies, and compliance with industry-specific regulatory frameworks. Collaboration & Stakeholder Engagement Work closely with business users, analysts, and data scientists to translate requirements into scalable technical solutions. Migration Leadership Drive strategic data migrations from on-prem/legacy systems to cloud-native platforms with minimal risk and downtime. Mentorship & Growth Mentor junior engineers, contribute to talent development, and ensure continuous learning within the team. Preferred candidate profile Python , SQL , PySpark , Databricks , AWS (Mandatory) Leadership Experience in Data Engineering/Architecture Added Advantage: Experience in Life Sciences / Pharma

Primary Responsibilities Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by Planning, creating, and implementing automated verification processes Creating associated validation documentation using proper documentation methods Assisting in the development and maintenance of automated testing procedures, processes, and quality standards Performing troubleshooting methods as necessary to maintain a stable and effective automated testing environment Working with software developers to resolve issues and retest applications Evaluating and analyzing test results Participating in project team meetings as needed Updating automated test scripts by Maintaining scripts and associated test matrices Identifying new areas for regression testing Mentors junior validation staff by Assisting in the quality review of automated validation packages and providing related feedback Assisting staff with problem solving and troubleshooting issues Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) Assisting in establishing and enforcing departmental standards including defining, documenting and implementing validation standards as needed Secondary Responsibilities Contributes to team effort by Training staff on departmental processes, validation protocol, testing techniques and documentation methods. Performing code reviews and offer feedback on best coding practices when necessary. Evaluating, monitoring and prioritizing workload of staff to ensure projects are on time; affecting change when necessary Offering technical and quality feedback/advice to both internal and external client. Working with internal staff including technical staff, project managers and applications developers to assist with the development of project specifications Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned Maintains Technical and Industry Knowledge by Attending and participating in applicable company-sponsored training Qualifications: Education: Bachelor s Degree in Computer Science, Engineering, Life Sciences or related field required; Master s preferred. Experience: 4+ years experience in validation/software testing required Experience working with test automation tools such as Coded UI, Selenium, Ranorex, Test Complete preferred Experience working with computer software including Word, Excel and Access preferred 2+ years experience working with clinical trials and/or within pharmaceutical environment preferred Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11 preferred Proven problem-solving abilities Additional skill set: Ability to adjust to changing priorities Strong understanding automated software QA methodologies Excellent attention to detail and orientation toward careful meticulous work Must be highly motivated, result-oriented, and possess the ability to handle multiple projects with multiple deadlines concurrently with minimal supervision Strong problem-solving, documentation and organizational skills Excellent oral and written communication skills Ability to project and maintain a professional and positive attitude Working conditions: Travel: 0-5% Lifting: 0-25lbs Other: Computer work for long periods of time This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs. Acknowledgement By electronically signing off on this document, I am acknowledging that I have received a copy of my job description and I understand my roles and responsibilities as it relates to my position. EEO Statement Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

A highly motivated and analytical Pharma Competitive Intelligence professional to join our growing team. You will be responsible for delivering timely, accurate, and actionable insights to support strategic business decisions, managing competitor monitoring projects, and producing in-depth market and competitive landscape reports. The ideal candidate should demonstrate strong cross-functional collaboration, clear communication, and the ability to work independently in a fast-paced, global environment. This is a critical role requiring immediate impact and deep CI expertise, along with a forward-looking mindset to leverage AI tools that enhance research workflows, accelerate insight generation, and improve overall efficiency. Key Responsibilities: Independently develop and deliver in depth, comprehensive CI deliverables including periodic monitoring, indication-based pipeline landscapes, competitor asset profiles, market landscapes, key event trackers, competitor approval timelines, conference coverage, newsletters etc. Analyze and triangulate information from multiple secondary data sources and propriety databases such as TrialTrove, PharmaProjects, Cortellis, Evaluate, DRG, AlphaSense, and more to deliver holistic competitor profiles and landscape assessments Develop client- ready outputs (slides or documents) with the best suited data synthesis and convincing visualization to convey key messages while maintaining rigorous quality checks on insights and outputs to ensure data accuracy and relevance Manage multiple CI projects under tight timelines interfacing with global clientele and prioritize requests based on the criticality and client expectations and strategic priorities Leverage advanced tools and innovative methods, including AI to enhance data collection, accelerate analysis, and improve efficiency and impact of deliverables by thinking beyond traditional approaches Understand business context about key client assets and competitor dynamics to monitor KITs/KIQs, and develop meaningful insights and recommendations from diverse data sources What You Bring: Experience: 4-6 years experience in competitive intelligence in pharmaceutical or life sciences industry Functional Skills: In-depth understanding of global pharmaceutical markets across development stages early pipeline, pre-launch, and marketed products including clinical development processes, regulatory pathways, and commercial considerations Strong experience in working with pharmaceutical databases including (but not limited to) BioMed tracker, PharmaProjects, Trial trove, IQVIA, Cortellis, Evaluate, DRG, AlphaSense Past experience of contributing to projects in but not limited to market landscaping, product/asset profiling, competitor benchmarking, pipeline assessments, conference monitoring, and triangulating data from multiple sources Proficient in Microsoft Office tools (PowerPoint, Excel, Word); ability to create compelling, insightful, and client-ready deliverables presentations and reports Awareness of and curiosity about AI/ML tools and their potential applications in CI workflows Behavioral Skills: High learning agility and a proactive mindset Resilient and adaptable in a dynamic, fast-paced work environment Team player with leadership potential, willing to take ownership and contribute to collective success Strong collaboration and interpersonal skills and work independently within a global and multicultural team (both virtual and in-person) Effective communication and articulation skills, ability to convey complex insights in a structured and impactful manner Strategic thinking to connect dots across data sets with attention to detail Good organizational, time management and priority setting skills, and the flexibility to multi-task Preferred Qualifications: Educational Qualifications: PhD/Masters Degree in Life Sciences. MBA from reputed institutes.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for supporting business processes within Global Business Services, driving program management including but not limited to governance, transition and continuous improvements Job Responsibilities Responsible for operational excellence in line with GBS operating model by driving governance framework as per GBS operating model Drive governance for GBS operational plans Publish operational dashboards. Trend and analyze for governance Track execution of operational actions. Report against plan on outcomes realized from actions Champion Continuous Improvement Initiatives at GBS Drive meeting as per agreed governance framework for all processes Ensure transition excellence by implementing 6D methodology for all process transfers Manage RAID (Risk, Action, Issue, Decision) across GBS for people, process and systems Escalate process risks and issues appropriately collaboratively with the Service Leaders and Operational Leaders Support Quality Management Team for activities as aligned Support regulatory and customer audits, when required Escalate unresolved issues to immediate supervisor Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Minimum Post Graduate, preferably in the field of Life-sciences Knowledge, Skills and Abilities Excellent communication skills Multitasking and good at analytics Adept with Microsoft office suite of applications Capability to work in a matrix environment Experience 5-8 yrs of similar industry experience At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Responsibilities & Key Deliverables Provides technical consultation on various aspects of the product and solutions based on the customer s business requirements. Responsible for designing/architecting the overall solution and development part with the help of development for large-scale customers; Validates solution components and provide solution walkthrough with customer; Identify technical issues / risks and present alternatives to alleviate or resolve Guide and support team across multiple client engagements by providing technical thought leadership and guide team on standard methodologies for design & development. Drive innovation within the practice/team by creating/identifying reusable components, tools, accelerators & as well work on increasing adoptions of these accelerators during delivery Experience 1. 10+ years experienced Technical Architect specialized in designing and delivering Industry specific applications for Salesforce Cloud solutions. 2. Proven record of delivering enterprise level scalable solutions across Customer Relationship Management (CRM), Automotive, Insurance, Real Estate, Financial Services, Healthcare & Utilities industries 3. Salesforce certifications such as Salesforce Certified Technical Architect, Salesforce Certified AI Specialist, or equivalent. 4. 4+ years of experience working as a developer in Salesforce. 5. In-depth knowledge of the basic capabilities of the Salesforce platform and products (especially Marketing Cloud, Call Center and Data), including an understanding of the data model, integration capabilities, development and maintenance best practices, as well as the pros and cons of the available tools and frameworks. Industry Preferred Industry expertise preferred:: Automobile Industry Real Estate - Pre / Post sales and Leasing Airline Industry Healthcare /Life Sciences Qualifications 1. Bachelor s degree in computer science, Information Technology, or a related field. 2. Proven experience as a Technical Architect in Salesforce General Requirements Technical Skills: CRM Solution Architecture Salesforce App Development Lightning Framework SOAP/REST Integration Architecture Execution Planning (including Accounts and Contacts, Surveys, KPIs and Assessment Tasks, Action Plan templates, Visits and Salesforce Maps) LWC, Apex, Configuration based Salesforce solutions including scaling complex UIs Agentforce, Salesforce Chatbot, and Einstein AI. Understanding of Data Analytics, AI, Large Language Models (LLM), and Natural Language Processing (NLP) ecosystems General Requirements: 1. Ability to mentor, coach, and develop team members. 2. Strong analytical and problem resolving skills. 3. Excellent executive communication skills, both written and verbal. 4. Strong pdecision-making skills. 5. Ability to drive innovation and encourage creative solutions. 6. Strong collaboration skills, promoting effective teamwork and communication among peers and stakeholders.

Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives . Manage the quality assurance oversight of projects, assignments, training and staff. Essential Functions Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies. Oversee and participate in the documentation, reporting, and closure of compliance issues. Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc. Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified. Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. Serve as author of Quality Assurance Standard Operating Procedures ( SOPs) as assigned. Advise Quality Assurance management on system audit needs. Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status. Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed Qualifications Bachelors Degree Pref 7 years Quality Assurance experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience. Knowledge of word-processing, spreadsheet, and database applications. Extensive knowledge of pharmaceutical research and development processes and regulatory environments. Considerable knowledge of quality assurance processes and procedures. Strong interpersonal skills. Excellent problem solving, risk analysis and negotiation skills. Exceptional training capabilities. Effective organization, communication, team orientation, and leadership skills. Ability to work independently with initiative. Ability to manage multiple projects. Ability to establish and maintain effective working relationships with coworkers, managers and clients. . IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

Overview:- Join global organization with 82000+ employees around the world, as a Automation testing role based in IQVIA Bangalore. You will be part of IQVIA s world class technology team and will be involved in design, development, enhanced software programs or cloud applications or proprietary products. :- Under general supervision, conducts quality assurance testing of highly complex software applications. Essential Functions Understands and reviews requirements, creates test plans and/or contributes in test estimations, manual and automation planning. Performs test case planning, authoring and execution of compliance products for client implementation projects. Supports and performs test iterations, defect tracking and reports test results; coordinates with team Works closely with Developers, Tech Leads/Managers, BAs/Consultants and other project stakeholders throughout the SDLC. Coordinates with BAs and development teams in troubleshooting and resolving issues. Regularly documents, tracks and escalates issues as appropriate. Hands on experience in running automated test scripts and identifying scope for areas for automation. Seeks necessary managerial support to discuss/flag risks and mitigation plans Typically requires 1 year of prior relevant experience Qualifications Bachelors Degree Computer Science, a related field, or equivalent experience Req IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e. g. , Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc. ), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents. Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents. Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e. g. , Canadian Annual Report). Primary Responsibility Communicate WWS s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance. Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs. Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. Develop and sustain constructive relationships within other Pfizer lines including country organizations. If assigned by manager, serve as the WWS point of contact for all document issues for a given product or set of products. Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line. Education: Bachelors Degree in life sciences and 3+ years relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas Advanced degree preferred (MD, DVM, PharmD, or Master s/PhD in relevant field) Experience and Attributes: Able to execute routine analyses and interpret routine safety analyses with guidance from team members ( analytic skills) Has comprehensive understanding of regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance ( regulatory knowledge) Is able to synthesize analyses of aggregate or individual patient data into clearly written text with minimal supervision. (writing skills) Has good understanding of medical concepts of the disease and the specific approach to treatment. Makes decisions that require choosing between multiple options to resolve moderately complex problems, some of which deviate from standard situations. (analytic skills, and maybe interpersonal skills as well) Medical #LI-PFE

Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e. g. , Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc. ), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents. Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents. Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e. g. , Canadian Annual Report). Primary Responsibilities Communicate WWS s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. If overseeing the work of or leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance. Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs. Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. Develop and sustain constructive relationships within other Pfizer lines including country organizations. Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line. Education Bachelors Degree in life sciences and 2+ years relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas Advanced degree preferred (MD, DVM, PharmD, or Master s/PhD in relevant field) Experience and Attributes Able to execute routine analyses and interpret routine safety analyses with guidance from team members ( analytic skills) Understands regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance ( regulatory knowledge) Is able to synthesize analyses of aggregate or individual patient data into clearly written text under general supervision. (writing skills) Has basic understanding of medical concepts of the disease and the specific approach to treatment. Makes decisions that require choosing between multiple options to resolve moderately complex problems in standard situations. (analytic skills, and maybe interpersonal skills as well) Medical #LI-PFE

Prefer Immediate joiners Position Summary As the Head of SAP, you will play a pivotal role in driving the organization towards digital transformation and operational excellence. Your vision will be to leverage SAP S/4 HANA as a catalyst for innovation, efficiency, and strategic growth. By implementing best-in-class solutions and optimizing business processes, you will empower our teams to unlock their full potential and deliver exceptional value to our customers and stakeholders. Your leadership will be instrumental in shaping the future of our organization, positioning us as a leader in the industry and driving sustainable success in an ever-evolving landscape. You will lead and oversee the implementation and optimization of SAP S/4 HANA within our organization. Reporting directly to the CIO, you will be responsible for driving strategic initiatives, streamlining processes, and ensuring the successful integration of SAP S/4 HANA across all departments. Additionally, 10-12 people will report to this position, in addition to the outsourced partner. Key Result Areas 1. SAP Implementation Leadership: Lead the planning, execution, and management of SAP S/4 HANA implementation projects from initiation to completion. Ensure alignment with organizational goals, timelines, and budgetary constraints. 2. Financial Expertise: Utilize your strong background in finance to understand and address the unique financial requirements and challenges of the organization. Collaborate with finance teams to develop and implement solutions that optimize financial processes within SAP S/4 HANA. 3. Business Process Optimization: Identify opportunities for business process improvement and optimization through the implementation of SAP S/4 HANA. Work closely with cross-functional teams to streamline workflows, enhance efficiency, and drive productivity gains. 4. Change Management: Lead change management efforts to drive user adoption and acceptance of SAP S/4 HANA across the organization. Develop and execute comprehensive change management plans, including training programs and communication strategies. 5. Vendor Management: Manage relationships with SAP implementation partners, consultants, and vendors. Ensure adherence to project scope, deliverables, and service level agreements (SLAs) to achieve successful outcomes. 6. Technical Expertise: Serve as a subject matter expert on SAP S/4 HANA functionality, capabilities, and best practices. Provide guidance and support to internal teams on system configuration, customization, and integration requirements. 7. Risk Management: Identify and mitigate project risks and issues to minimize potential disruptions to implementation timelines and objectives. Proactively address challenges and obstacles to ensure the successful delivery of SAP S/4 HANA projects. 8. Continuous Improvement: Drive a culture of continuous improvement within the SAP team and across the organization. Monitor key performance indicators (KPIs) and metrics to evaluate the effectiveness of SAP S/4 HANA implementation and identify areas for enhancement. Qualifications & Experience: Bachelor's degree in finance, Business Administration, Information Technology, or a related field. Proven record of accomplishment of at least 5 years in successfully leading SAP S/4 HANA implementation projects in a mid-sized organization, with additional pharmaceutical industry experience being a significant advantage. Extensive experience of at least 5 years in finance, accounting, or related fields, with a deep understanding of financial processes and systems. Advanced knowledge of SAP S/4 HANA modules, functionality, and configuration options. Certification in SAP S/4 HANA or relevant SAP modules preferred. Strong leadership skills with the ability to inspire, motivate, and mentor cross-functional teams. Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities simultaneously. Excellent communication, interpersonal, and stakeholder management skills. Experience with change management, business process optimization, and project management methodologies

Eligibility Criteria: Designation: Trainee Medical Code Qualification: Life Science Graduates can apply (No Standing Arrears) Should have 60% in all the academics Work From Office only Work Location: Chennai Shift: Day Salary: As per Industry Age Limit: 28 yrs Interested candidates share your resume durgadevi.chandrasekaran@corrohealth.com Durga HR - 8248059972

Role & responsibilities Scrum master should be able to create the environment for a team to deliver value, be highly independent, confident in their abilities and flexible enough to adapt to an evolving landscape. Responsible for ensuring Scrum is understood and the team adheres to Scrum practice, and guidelines. Works with Multiple Scrum Teams , as well as internal and external stakeholders, to influence and drive decision making and support organizational project or product teams. Facilitates and supports all scrum events: Sprint Planning, Daily Scrum, Sprint Review, and Sprint Retrospective. Removing impediments or guiding the team to remove impediments. Facilitating discussion, decision making, and conflict resolution. Supporting and educating the Product Owner, especially on grooming and maintaining the product backlog. Providing all support to the team using a servant leadership style whenever possible and leading by example. Scrum is understood and the team adheres to Scrum theory, practice, and guidelines. Good skills and knowledge of servant leadership, facilitation, situational awareness, conflict resolution, continual improvement, empowerment, and increasing transparency. Adept at refinement, story splitting, estimation, velocity, retrospection , and other Scrum techniques. Planning and problem-solving involving product management and delivery teams. Assisting with internal and external communication, improving transparency, and radiating information on team performance and progress using key Agile metrics. Working with the Product Owner to align team with product vision and sprint goals and participate in product backlog preparation activities. Mitigate risks and communicate to leaders using best practices in Agile. Instill continuous improvement activities to reduce waste and increase productivity. Leverage skills from coaching, facilitation, conflict resolution and more to guide teams to embrace Agile mindset. Handle the escalations and conflict within the project team. Experience working with geographically dispersed clients. Excellent communication and articulation skills. Preferred candidate profile 6-9 years of experience as a Scrum Master Life sciences/Pharma domain experience is a must Proven experience managing technology transformation, digital health, lab systems (e.g., LIMS, ELN), clinical systems (e.g., CTMS), manufacturing systems or similar. Strong understanding of regulatory environments and compliance standards (FDA, GxP, CSV, etc.). Good understanding of industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Hands on experience as Scrum Master/ Agile Project Manager for at least for 3-4 years. Hands on experience in Software Life Cycle (SDLC), waterfall, hybrid and agile projects Experience in using Scrum, Kanban, SAFe, Lean Agile frameworks. Experience in Project Management tools such as JIRA, ADO etc. SAFe/ CSM / PSM equivalent certification. Bachelors in Engineering / MBA. PMP certification, Agile or SAFe certification preferred. The experience in applying a wide variety of well-documented patterns and techniques to enhance the Scrum approach (e.g. Estimation Techniques, progress visualization techniques, retrospective formats, approaches for handling bugs , etc.). Excellent communication skills, both written and verbal Excellent coaching and mentoring skills

Role & responsibilities Lead end-to-end project management for IT/technology initiatives in the pharma/life sciences domain, ensuring timely delivery and within budget. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Commercial teams. Define project scope, objectives, deliverables, milestones, and timelines. Manage vendor coordination, software implementation, system integration, and infrastructure deployments. Ensure alignment of projects with industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Prepare detailed project plans, status reports, risk mitigation strategies, and issue logs. Act as a single point of contact for stakeholders, ensuring effective communication and expectation management. Facilitate change management, training, and adoption strategies. Ensure adherence to internal project governance, compliance, and validation procedures. Preferred candidate profile 1012 years of total experience in IT/Technology Project Management, with at least 5 years in the Pharma/Life Sciences domain. Proven experience managing technology transformation, digital health, lab systems (e.g., LIMS, ELN), clinical systems (e.g., CTMS), manufacturing systems or similar. Strong understanding of regulatory environments and compliance standards (FDA, GxP, CSV, etc.). Hands-on experience with Agile, Scrum, or Hybrid delivery methodologies. Ability to manage cross-functional teams and third-partyvendors. Excellent communication, stakeholder management, and leadership skills. PMP/Prince2/CSM certification is a plus Good To Have Experience with data platforms, analytics in pharma, or AI/ML initiatives in life sciences. Exposure to cloud migrations, enterprise platformslike SAP, Veeva, Oracle Health Sciences, etc. Prior experience with global project rollouts across geographies. Understanding of pharma manufacturing processes, quality control, or clinical development lifecycle

Hiring for Sm and ASM For Following locations: Jaipur/ Chennai/ Hyderabad/ Bangalore/ Ahmedabad/ Vadodara /Kolkata / North delhi Job Responsibilities: Generate requirements from existing Actual Users. Close Orders with Purchase, Procurement Personnel. Distributor Management in terms of Sales & Collection Target Achievement. New Business Development. Implement Marketing Strategies. Deliver profitable growth. Key Skills: Knowledge of Basic Analytical/Life Science techniques. Handling of Customer Queries and secure orders Product Knowledge and using product features/benefits to generate demand Key account management, Negotiation, Trade Handling Preference: Exposure to working with products related to QC Labs in Pharma Industry and Research & Educational Labs. Products could be Lab Chemicals/Glassware/Microbiology Media/Reagents/Chromatography Products/Filtration Products

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager, Global Regulatory Intelligence The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process. Key Responsibilities: Intelligence Gathering & Analysis: Assist in monitoring and analyzing the global regulatory landscape, and in developing intelligence reports and updates as directed by the RI Director. A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgen s local regulatory teams, for the Manager s assigned areas of responsibility. This information feeds into the group s centralized knowledge base. The Manager helps execute the regulatory intelligence workplans by preparing agreed deliverables for example, compiling monitoring reports, bulletins, and landscape summaries that highlight regulatory changes or requirements relevant to upcoming filings. They ensure that these deliverables are coherent and actionable, providing clear recommendations or insights where appropriate . Tools & Data Management: Take ownership of the tools, databases, and documentation that support intelligence gathering and dissemination. The Manager is responsible for facilitating and maintaining these systems on a day-to-day basis. This includes ensuring that repositories of regulatory requirements and intelligence reports are up-to-date and accessible to stakeholders. Importantly, the Manager may also be expected to build or modify new tools and databases as needed, not just use existing ones. (For example, if a new tracking database or dashboard is required to capture regulatory changes, the Manager would play a key role in its development or configuration.) Emphasizing this in the job description sets clear expectations that the role involves technical initiative in improving intelligence systems. Cross-Functional Support: Work closely with other members of the Regulatory Policy & Intelligence team and with regulatory staff in various functions to ensure intelligence is applied effectively. The Manager engages with policy analysts, product regulatory leads, and other cross-functional team members to share findings and gather input. While the Manager may not lead cross-functional projects independently, they support these efforts by providing the necessary data or analysis. For instance, if a cross-product regulatory strategy project is underway, the Manager might supply the compiled country requirements or recent regulatory changes needed for decision-making. They help ensure that agreed intelligence deliverables are executed on time and that any intelligence requests from internal stakeholders are addressed promptly. Progress Tracking & Improvement: Monitor the progress of intelligence-gathering activities against the team s objectives and timelines. The Manager tracks their assignments (e.g., monitoring tasks or updates due) and regularly reports status to the RI Director. If there are delays or obstacles in obtaining information, the Manager flags these and helps troubleshoot solutions. Additionally, the Manager contributes to process improvement discussions identifying any inefficiencies in how intelligence data is collected or shared and suggesting enhancements. They participate in continuous improvement of the function s processes and tools, helping to refine workflows for greater efficiency and reliability. Knowledge & Skills: Regulatory Knowledge: A solid grounding in regulatory affairs processes and requirements is needed. The Manager should understand regulatory submission guidelines and procedures across different regions (major markets and smaller markets) and have familiarity with how local regulations impact drug development and filings. While they may rely on senior staff for deeper analysis, the Manager must be able to interpret regulatory documents or health authority guidance and extract key points. The ability to handle complex information and distill it into clear summaries is crucial often the Manager will be the first to review new regulations and must highlight what matters to Amgen s products. Attention to Detail and Analytical Skills: The role requires strong analytical abilities and attention to detail. The Manager will be dealing with regulatory texts, tracking changes, and inputting data into intelligence systems so accuracy is paramount. They should be skilled at comparing regulatory requirements and spotting differences or trends. At the same time, they need to maintain a big-picture view to recognize how a particular change might affect Amgen s global filing strategy. Being able to propose practical solutions or escalate important findings is part of this analytical skill set. Technical and Project Skills: Proficiency in using information systems and databases is important, as this role often acts as the power user of regulatory intelligence tools. Experience with managing or configuring databases, spreadsheets, or tracking tools will be useful. The Manager should also have good project coordination skills capable of managing their own workstreams, meeting deadlines, and juggling multiple intelligence requests or projects. Strong written and oral communication skills are needed to draft clear reports and to communicate findings to the team or other stakeholders. Additionally, a willingness to learn and even create new technical solutions (e.g., leveraging an internal SharePoint site or an intelligence software platform) is highly valued in this position. Qualifications: Education & Experience: It is recommended that candidates have at least a Bachelor s degree in a relevant discipline (such as life sciences or regulatory affairs) plus relevant experience in regulatory or drug development roles. An advanced degree ( Master s or higher) in a related field is a plus. While Amgen s internal templates for similar roles have sometimes listed lower educational minima ( e.g. associate degree or high school with significant years of experience), for a Regulatory Intelligence Manager it is preferable to require a Bachelor s degree as the minimum qualification . This ensures the candidate has a sufficient foundation to grasp complex regulatory information. In terms of experience, a few years of hands-on regulatory affairs or regulatory operations experience (for instance, ~3-5 years with a Bachelor s degree ) would likely be expected, given the need to work independently and with understanding of the regulatory context. Preferred Background: Relevant industry experience in pharmaceutical/biotech regulatory affairs or compliance is strongly preferred. Experience specifically with regulatory intelligence or policy tracking whether in a prior role or via project work would allow a new hire to hit the ground running. Familiarity with regulatory intelligence tools or subscription databases (such as Tarius or similar services) and experience interacting with global regulatory colleagues would also be advantageous . The ideal candidate will be one who not only has the technical skills to manage data and tools, but also the curiosity and insight to understand why regulatory changes matter and how to communicate those insights effectively.

This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps , use cases , and test plans for the software development teams. This enabl es the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. Y ou will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre- clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. You will implement and manage scientific software platforms across the research informatics ecosystem , and provide technical support, training, and infrastructure management , and ensure it meets the needs of our Amgen R esearch community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework ( SAFe ) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and milestones Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. Basic Qualifications and Experience: Master s degree with 1 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/Bioinformatics or related field , OR Bachelor s degree with 3 - 5 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/Bioinformatics or related field , OR Diploma with 7 - 9 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/ Bioinformatics or related field , OR Preferred Qualifications: 3 + years of experience in implementing and supporting LIMS platforms . Functional Skills: Must-Have Skills : Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data E xperience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS platforms such as STARLIMS, Watson LIMS , LabVantage, etc. Good-to-Have Skills: Experience in the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation , and k nowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud ( e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile process es and principles for coordinated solutions and teams via SAFe Knowledge of business analysis best practices, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certification s: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation . .

Career Category Information Systems Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human data to push beyond what s known today. ABOUT THE ROLE Let s do this. Let s change the world. At Amgen, we believe that innovation can and should be happening across the entire company. Part of the Artificial Intelligence & Data function of the Amgen Technology and Medical Organizations (ATMOS), the AI & Data Innovation Lab (the Lab) is a center for exploration and innovation, focused on integrating and accelerating new technologies and methods that deliver measurable value and competitive advantage. We ve built algorithms that predict bone fractures in patients who haven t even been diagnosed with osteoporosis yet. We ve built software to help us select clinical trial sites so we can get medicines to patients faster. We ve built AI capabilities to standardize and accelerate the authoring of regulatory documents so we can shorten the drug approval cycle. And that s just a part of the beginning. Join us! We are seeking a Senior DevOps Software Engineer to join the Lab s software engineering practice. This role is integral to developing top-tier talent, setting engineering best practices, and evangelizing full-stack development capabilities across the organization. The Senior DevOps Software Engineer will design and implement deployment strategies for AI systems using the AWS stack, ensuring high availability, performance, and scalability of applications. Roles & Responsibilities: Design and implement deployment strategies using the AWS stack, including EKS, ECS, Lambda, SageMaker, and DynamoDB. Configure and manage CI/CD pipelines in GitLab to streamline the deployment process. Develop, deploy, and manage scalable applications on AWS, ensuring they meet high standards for availability and performance. Implement infrastructure-as-code (IaC) to provision and manage cloud resources consistently and reproducibly. Collaborate with AI product design and development teams to ensure seamless integration of AI models into the infrastructure. Monitor and optimize the performance of deployed AI systems, addressing any issues related to scaling, availability, and performance. Lead and develop standards, processes, and best practices for the team across the AI system deployment lifecycle. Stay updated on emerging technologies and best practices in AI infrastructure and AWS services to continuously improve deployment strategies. Familiarity with AI concepts such as traditional AI, generative AI, and agentic AI, with the ability to learn and adopt new skills quickly. Functional Skills: Deep expertise in designing and maintaining CI/CD pipelines and enabling software engineering best practices and overall software product development lifecycle. Ability to implement automated testing, build, deployment, and rollback strategies. Advanced proficiency managing and deploying infrastructure with the AWS cloud platform, including cost planning, tracking and optimization. Proficiency with backend languages and frameworks (Python, FastAPI, Flask preferred). Experience with databases (Postgres/DynamoDB) Experience with microservices architecture and containerization (Docker, Kubernetes). Good-to-Have Skills: Familiarity with enterprise software systems in life sciences or healthcare domains. Familiarity with big data platforms and experience in data pipeline development (Databricks, Spark). Knowledge of data security, privacy regulations, and scalable software solutions. Soft Skills: Excellent communication skills, with the ability to convey complex technical concepts to non-technical stakeholders. Ability to foster a collaborative and innovative work environment. Strong problem-solving abilities and attention to detail. High degree of initiative and self-motivation. Basic Qualifications: Bachelor s degree in Computer Science, AI, Software Engineering, or related field. 8+ years of experience in full-stack software engineering.

We are seeking a seasoned Senior Engineering Manager ( Data Engineer ing) to lead the end-to-end management of enterprise data assets and operational data workflows. This role is critical in ensuring the availability, quality, consistency, and timeliness of data across platforms and functions, supporting analytics, reporting, compliance, and digital transformation initiatives. As a senior leader in the data organization, you will oversee the day-to-day data operations, manage a team of data professionals, and drive process excellence in data intake, transformation, validation, and delivery. You will work closely with cross-functional teams including data engineering, analytics, IT, governance, and business stakeholders to align operational data capabilities with enterprise needs. Roles & Responsibilities: Lead and manage the enterprise data operations team, responsible for data ingestion, processing, validation, quality control, and publishing to various downstream systems. Define and implement standard operating procedures for data lifecycle management, ensuring availability, accuracy, completeness, and integrity of critical data assets. Oversee and continuously improve daily operational workflows, including scheduling, monitoring , and troubleshooting data jobs across cloud and on-premise environments. Establish and track key data operations metrics (SLAs, throughput, latency, data quality, incident resolution) and drive continuous improvements. Partner with data engineering and platform teams to optimize pipelines, support new data integrations, and ensure scalability and resilience of operational data flows. Collaborate with data governance, compliance, and security teams to maintain regulatory compliance, data privacy, and access controls. Serve as the primary escalation point for data incidents and outages, ensuring rapid response and root cause analysis. Build strong relationships with business and analytics teams to understand data consumption patterns, prioritize operational needs, and align with business objectives . Drive adoption of best practices for documentation, metadata, lineage, and change management across data operations processes. Mentor and develop a high-performing team of data operations analysts and leads. Functional Skills: Must-Have Skills: E xperience managing a team of data engineers in biotech/pharma domain companies . E xperience in designing and maintaining data pipelines and analytics solutions that extract, transform, and load data from multiple source systems. Demonstrated hands-on experience with cloud platforms (AWS) and the ability to architect cost-effective and scalable data solutions. E xperience managing data workflows on Databricks in cloud environments such as AWS, Azure, or GCP. Strong problem-solving skills with the ability to analyze complex data flow issues and implement sustainable solutions. Working knowledge of SQL, Python, PySpark or scripting languages for process monitoring and automation. Experience collaborating with data engineering, analytics, IT operations, and business teams in a matrixed organization. Familiarity with data governance, metadata management, access control, and regulatory requirements (e.g., GDPR, HIPAA, SOX). Excellent leadership, communication, and stakeholder engagement skills. Well versed with full stack development & DataOps automation, logging & observability frameworks, and pipeline orchestration tools. Strong analytical and problem-solving skills to address complex data challenges. Effective communication and interpersonal skills to collaborate with cross-functional teams. Good-to-Have Skills: Data Engineering Management experience in Biotech/ Life Sciences/ Pharma Experience using graph databases such as Stardog or Marklogic or Neo4J or Allegrograph , etc. Education and Professional Certifications 12 to 15 years of experience in Computer Science, IT or related field Databricks Certificate preferred Scaled Agile SAFe certification preferred Experience in life sciences, healthcare, or other regulated industries with large-scale operational data environments. Familiarity with incident and change management processes (e.g., ITIL). Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills