Pharmacist - retail pharmacy Dispensing medicines. With 6 months experience Sr pharmacist ATL Required Candidate profile Bpharma dpharma

Responsibilities: * Manage territory sales performance * Collaborate with healthcare professionals * Meet revenue targets * Develop & execute area strategy * Achieve target market penetration

Hiring Area Sales Officer / Medical Representative for A Leading AYURVEDIC PHARMA MNC BRAND Division: Gynae Ayurvedic Ethical Locations (Headquarters): Ahmedabad Borivali Thane Experience: 2-3 years Education: Any Graduate CTC: Attractive Package Number of Openings: 6 Role & Responsibilities: Promote and demonstrate products to Gynecologists, Pediatricians, and Pharmacists Ensure prescription generation and doctor engagement Handle both Primary and Secondary Sales Manage and coordinate with distribution partners: Stockists, Distributors, and Chemists

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Analyst Qualifications: MSc/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressure Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification MSc,Bachelor of Pharmacy,Master of Pharmacy

Project Role : Software Development Lead Project Role Description : Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills : Manufacturing Engineering MES Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Pharmasuite MES Architect, you will be responsible for designing, developing template based MES recipes in Rockwell FactoryTalk PharmaSuite (FTPS) to support pharmaceutical manufacturing processes. You will collaborate with cross-functional teams to ensure efficient recipe authoring and seamless integration with automation and enterprise systems while adhering to regulatory and industry standards. Roles & Responsibilities:-Develop MES recipes using Rockwell FTPS, ensuring compliance with industry best practices.-Design and implement building blocks for reusable recipe structures.-Work closely with process engineers and manufacturing teams to map end-to-end pharmaceutical processes, with a focus on biologics.-Ensure compliance with pharmaceutical regulations (GMP, GxP, 21 CFR Part 11).-Participate in the full MES lifecycle, from design and validation to deployment and support.-Perform recipe testing, troubleshooting, and validation in alignment with SDLC (Software Development Life Cycle) methodologies.-Collaborate with DCS teams to ensure seamless MES-DCS integration for automated manufacturing.-Support and maintain MES systems in a validated state, ensuring high availability and performance.-Provide technical expertise in MES implementation and contribute to continuous improvements in manufacturing processes.Must-Have Skills: -MES experience in life sciences manufacturing, specifically with Rockwell FTPS.-Hands-on experience in MES-DCS integration for process automation.-Knowledge of ERP and Data Historian integration with MES.-Hands-on experience in recipe authoring, building block development, and validation.-Strong understanding of pharmaceutical manufacturing, especially biologics. Professional & Technical Skills: -Knowledge of SDLC and pharmaceutical regulations (GMP, GxP, 21 CFR Part 11).-Experience in executing at least one full MES lifecycle project with demonstrated results.-Good communication skills to collaborate with cross-functional teams. Additional Information:-Minimum 5 to 7.5 years of experience in MES recipe design and deployment in pharmaceutical manufacturing.-This position is based at our Kolkata, Bengaluru, Pune, Mumbai, Chennai, Hyderabad and Ahmedabad office.-A full-time 15 years of education is required. Qualification 15 years full time education

About Advanced Data Science (ADS) : ZSs Advanced Data Science group is focused on creating practical impact for clients across various industries such as Healthcare and Bio-Tech, Hi-Tech & Telecommunication, Financial Services and Travel through advanced analytics and emerging data sources. Emerging datasets include both unstructured datasets (for example, text, voice, image, etc.) and semi-structured datasets (for example, patientlevel records). Advanced analytical techniques span a range of innovative machine learning, artificial intelligence, advanced statistics and optimization approaches. Being part of the ADS group at ZS will be an opportunity for you to work on cutting-edge solutions, utilizing new age data sources to shape innovations across multiple areas, for our clients and the broader ZS community. A key enabler of our services is leveraging data in delivering client solutions. The data available about customers is getting richer and the problems that our customers are trying to answer continue to evolve. In our endeavor to stay ahead in providing solutions to these evolving complex problems, ZS has set up an Advanced Data Science which has three major focus areas: Research the evolving datasets and advanced analytical techniques to develop new offerings/solutions Deliver client impact by collaboratively implementing these solutions Provide thought leadership by developing the ZS Point of View in this space Data Science Managers (DSMs) design, develop and execute analytic techniques on large, complex, structured and unstructured data sets (including big data) to help clients make better fact-based decisions. DSMs will develop new offerings/solutions, drive client impact by delivering client solutions and shape the ZS point of view in this space. You will be responsible for applying analytical techniques to model complex business problems, uncovering insights, and identifying opportunities using statistical, algorithmic, mining, and visualization techniques. What Youll Do: Lead and mentor a team of data scientists, providing guidance and support to ensure the successful execution of client projects. Develop and implement data science strategies that align with the overall goals of the AI team and the organization. Drive business and strategy development through project delivery and client relationship management; Develop/sell new business opportunities Direct multiple projects simultaneously, honing analytic and project management skills; Play a key role in development of data science capabilities and offerings that create scale and advance our analytic platform; Motivate, coach and serve as a role model for project team members Provide thought leadership and innovation through research and publication. What You’ll Bring: PhD degree in Computer Science, Statistics or related discipline will be highly preferred; 8+ years of relevant post-collegiate work experience; in lieu of a PhD, 10+ years of work experience may substitute. Experience with big data, claims analytics, advanced analytics concepts and algorithms (e.g. text mining, social listening, recommender systems, predictive modeling, Gen AI, proficiency with large language models etc.); Relevant programming background (e.g. Python/R); Strong understanding of relevant tools/platforms (e.g. cloud platforms such AWS/Azure); Proven track record of business development Agile project planning and project management experience; Team management and skill development experience; Relevant domain knowledge preferred; (healthcare, pharma); Excellent oral and written communication skills; Strong attention to detail, with a research-focused mindset; Excellent critical thinking and problem solving skills;

Product Owner - LIMS |10-16 Years| Hyderabad Product Owner - LIMS |10-16 Years| Hyderabad We are seeking a highly motivated and experienced Product Owner/Business Analyst/Subject Matter Expert to lead the development and enhancement of our Laboratory Information Management System (LIMS). This role will be responsible for defining and prioritizing product requirements, translating business needs into technical specifications, and ensuring the LIMS effectively supports our laboratory operations. The ideal candidate will possess a deep understanding of laboratory workflows, data management principles, and regulatory requirements within the [Specific Industry - e.g., Pharmaceutical, Biotech, Environmental Testing] industry. This is a hybrid role requiring a combination of product ownership, business analysis, and subject matter expertise. **Responsibilities:** * Define and maintain the product vision, strategy, and roadmap for the LIMS. * Prioritize and manage the product backlog, ensuring alignment with business goals and user needs. * Act as the primary point of contact for the LIMS product, representing the voice of the customer and stakeholders. * Collaborate with development teams to ensure successful product delivery. * Participate in sprint planning, daily stand-ups, sprint reviews, and retrospectives. * Translate business requirements into clear and concise user stories, acceptance criteria, and functional specifications. * Create process flows, use case diagrams, and other visual aids to communicate requirements effectively. * Conduct gap analysis to identify discrepancies between current and desired LIMS functionality. * Assist with user acceptance testing (UAT) and provide support to end-users * Serve as a subject matter expert on LIMS functionality, data management, and industry best practices. * Provide guidance and support to users on LIMS workflows and data entry procedures. * Stay up-to-date on industry trends and emerging technologies related to LIMS. * Participate in the evaluation and selection of new LIMS modules or enhancements. * Ensure the LIMS complies with relevant regulatory requirements, such as [e.g., FDA 21 CFR Part 11, GLP, GMP]. * Develop and deliver training materials and documentation for LIMS users. * Configure and customize the LIMS system to meet specific laboratory needs. 1. The Software Engineering Leader oversees and guides teams to deliver high-quality software solutions aligned with organizational goals and industry best practices.2. Is a professional in technology, proficient in strategic planning, decision-making, and mentoring, with an extensive background in software development and leadership.3. Is typically responsible for setting the strategic direction of software development efforts, managing project portfolios, and ensuring effective execution of software engineering initiatives to meet organizational objectives.4. Builds skills and expertise in leadership, staying abreast of industry trends, and cultivating a collaborative and high-performance culture within the software engineering team.5. Collaborates and acts as a team player with cross-functional teams, executives, and stakeholders, fostering a positive and productive environment for successful software development initiatives. - Grade Specific Skills (competencies) Verbal Communication

Overview About Role: We have an exciting role of Junior Copywriter to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About Omnicom Global Solutions Omnicom Global Solutions (OGS) is an agile innovation hub of Omnicom Group, a leading global marketing and corporate communications company. Guided by the principles of Knowledge, Innovation, and Transformation, OGS is designed to deliver scalable, customized, and contextualized solutions that meet the evolving needs of our Practice Areas within Omnicom. OGS India plays a key role for our group companies and global agencies by providing stellar products, solutions, and services in the areas of Creative Services, Technology, Marketing Science (Data & Analytics), Advanced Analytics, Market Research, Business Support Services, Media Services, and Project Management. We currently have 4000+ awesome colleagues in OGS India who are committed to solving our clients’ pressing business issues. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together! Why Omnicom Health (OH) At Omnicom Health, you’re not just starting a job—you’re becoming part of something bigger. As one of the largest and most specialized global healthcare networks, we’re dedicated to building the ideas and solutions of tomorrow. Your career here is about growth, impact, and the chance to shape the future of healthcare. Every day, the work you do will contribute to a greater cause, making a real difference in people’s lives About Our Agency Snow Companies The first and largest global patient engagement agency, innovating direct-to-patient marketing since 2001. Our core business focuses on partnering with biotech and pharma brands to connect with real patients and caregivers to design and implement direct-to-patient initiatives. Whether we’re building connections between brands and their patients or crafting compliant, patient-facing communications, we create content that enlightens and empowers. No other agency has made a bigger impact on the lives of patients around the world. Know more at: https://snow-companies.com/ Responsibilities • Content Creation: Develop creative and compelling copy for flyers, emails, recruitment cards, brochure, decks, direct mailers, children’s books, and some social media posts. • Pharma Experience: This role specializes in healthcare communications so knowledge in other relevant platforms and pharmaceutical regulation is a plus. • Storytelling: Collaborate with our writing team to identify markable points in a patient's story and translate them into engaging content that resonates with our audience. • Brand Voice: Maintain consistency in brand voice and messaging across all content while adhering to each platform's best practices and guidelines. • Campaign Support: Support the execution of brand campaigns by creating compelling copy and coordinating with internal teams to ensure seamless implementation. • Trends: Stay informed about industry trends and emerging platforms to continually innovate and improve our marketing copy.

|| Immediate Joiners || Dear Candidates, Please find the below Job Description. Qualification: BDS, MDS, BPT, MPT, BHMS, M.Pharma, B.pharma Experience: 05 years (Freshers welcome!) The role involves mapping clinical, laboratory, pharmacological, and other medical health terms to their corresponding concepts in standard medical terminologies, ensuring accurate representation of the source terms. Additionally, the position includes performing text labeling, data annotation, or image annotation tasks as assigned by the team. Notice Period : Immediate joiner Location : Noida sector 62 Shift Timing : 9PM - 6AM Regards, Manvi Rana mrana@innodata.com

QMS Implementation Audit facilitation: will represent the company during regulatory/ 3rd party audits: MHRA, USFDA, MCC, WHO, etc. Products: temperature-controlled packaging & temperature monitoring systems used for storage & transit of medicines Required Candidate profile Any science graduates 10-15 years' experience in quality, ideally in pharma/ medical devices/ equipment manufacturing industry International Audit Experience mandatory Should be open for global travel

PPP Card & Govt License Compulsory, D pharma or B pharma, Salary: 1.56 LPA Max

Overview About Role: We have an exciting role of Medical Editor - Analyst to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About Omnicom Global Solutions Omnicom Global Solutions (OGS) is an agile innovation hub of Omnicom Group, a leading global marketing and corporate communications company. Guided by the principles of Knowledge, Innovation, and Transformation, OGS is designed to deliver scalable, customized, and contextualized solutions that meet the evolving needs of our Practice Areas within Omnicom. OGS India plays a key role for our group companies and global agencies by providing stellar products, solutions, and services in the areas of Creative Services, Technology, Marketing Science (Data & Analytics), Advanced Analytics, Market Research, Business Support Services, Media Services, and Project Management. We currently have 4000+ awesome colleagues in OGS India who are committed to solving our clients’ pressing business issues. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together! Why Omnicom Health (OH) At Omnicom Health, you’re not just starting a job—you’re becoming part of something bigger. As one of the largest and most specialized global healthcare networks, we’re dedicated to building the ideas and solutions of tomorrow. Your career here is about growth, impact, and the chance to shape the future of healthcare. Every day, the work you do will contribute to a greater cause, making a real difference in people’s lives About our Agency Propeller Propeller is the digital-native, agile omnichannel healthcare agency, mobilizing data to drive meaningful results. Propeller develops and executes strategy to bring brand vision to life, leveraging its full-service, state-of-the-art digital suite and omnichannel principles. Know more at: https://www.propellercommunicates.com/#about Responsibilities Location: Remote Responsibilities: Understand and document client-mandated submission requirements and ensure these protocols are maintained. With guidance from MLR/Submission managers, create, uphold, and maintain submission checklists for assigned brands. Stay current with new electronic submission and regulatory documentation practices and standards. Ensuring accurate and timely MLR submissions into Client systems: Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines. Annotate any notes/comments relevant to MLR reviewers onto the submission file (including "red boxing" as required for identifying derivative/pick-up content, or callouts for new changes between reviews). Performing QC of MLR submission components/package prepared by the team, before submission. [this is not an editor role] Preparation and submission of MLR-submission, including electronic tagging and linking references in Client system. Establish and build relationships with all internal cross-functional team members: In collaboration with the Copy department, organize references to streamline project submissions. Support your cross-functional team with opening projects in Client review platforms. In collaboration with the Editorial team, if appropriate, proofread/fact check against multiple source documents to confirm annotation accuracy. Qualifications Required Skills: 4-5 years of relevant work experience, preferably in science, medicine, or at a pharmaceutical advertising agency. Bachelor’s degree in science, specifically related to medicine or pharma Proficiency in Microsoft Office (Word, Outlook, Excel, PowerPoint) and Adobe Acrobat. Familiarity with Veeva PromoMats and PubMed Extremely detail-oriented and organized approach Ability to work collaboratively with multiple departments and levels within the agency Strong team-oriented approach and excellent interpersonal skills Ability to thrive and grow in a fast-paced environment Ability to prioritize deadlines and work under pressure

Sales domestic & export documentation including Sale Orders & Bill of lading DGD & Non-Hazardous certificates Create & manage Sales Orders in SAP for domestic, international, sample based on POs & email approvals Shipping & Logistics Coordination Required Candidate profile 4+ years of experience majoring in Export Documentation specifically within the Chemical and Pharmaceutical industries. Experience of working in SAP. Education - Graduate/PG/PGDM/MBA (Full-time) Perks and benefits GTLI/GPA/GMC

1.Requirement gathering from Factory 2.Handling Existing and New Vendor management 3.Quotation and order placement 4.Getting best quote and supply the material to factory on time

Developing and executing strategic sales plans, managing a team of sales representatives, and achieving sales targets to drive business growth. Monitor performance metrics and provide regular sales forecasts Required Candidate profile Proven experience (10+ years) in sales, with at least 4 years in a Area Manager or Regional Manager Large Team handling experience.

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate’s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

Senior Associate Finance-R&D What you will do Let’s do this. Let’s change the world. In this vital role you will you will report to the Director of Consolidation in R&D Finance. The R&D Finance Senior Associate will assist in planning, quarter close and consolidation activities. The candidate is also expected to expand the centralization, automation and standardization practices established in R&D Finance team. In addition, the candidate is expected to provide support and guidance to other senior finance associates based in Amgen India. Experienced FP&A professional skilled in comprehensive financial data management, financial analysis and forecasting, ad hoc project financial support, and process optimization. Support functional and consolidation teams in R&D finance including Research, Development and the Office of the Chief Medical Office Master Data Maintenance including but not limited to managing and updating financial master data across all systems to ensure accuracy and integrity, cost center creation, modification, and deactivation, aligning them with the organizational structure, creation of Work Breakdown Structures (WBS) for precise project tracking and financial reporting. Provide headcount and staffing support by maintaining relevant data and assisting in workforce planning. Support efficient data migration from the business planning tool to financial system FE&O and Staff Support planning and Variance AnalysisConduct variance analysis to identify trends and discrepancies between actuals and forecasts. Forecasting of certain trended/low risk planning accounts Provide functional support related to certain function specific process like FSP reporting for BARDA, GMIP, Milestones planning, Functional/Corporate transfers Product Coding and Recovery OptimizationSupport product coding processes and recovery methods to improve financial accuracy and efficiency. Handle Non-Time Sensitive RequestsManage ad-hoc financial requests that are not time-sensitive, providing accurate and timely support to stakeholders. We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 1 to 2 years of accounting and/or finance (OR) Bachelor’s degree and 3 to 6 years accounting and/or finance (OR) Diploma and 8 to 10 years of accounting and/or finance experience Preferred Qualifications: Pharmaceutical / biotechnology industry experience Knowledge and understanding of financial planning processes, quarter close activities Strong analytical skills and exceptional attention to detail Excellent discernment (e.g., knowledge of business drivers, finding solutions, and knowledge of accounting, finance, and other business areas) Good To Have Skills Big 4 and Fortune 500 FP&A experience Capable of building models and financial reports Solid technical finance knowledge and skills (accounting, planning, modeling, etc.) Solid overall knowledge of financial systems and tools (e.g., SAP, Hyperion, Anaplan, Excel) Proven business partnering skills Proven ability to work effectively in ambiguous situations and team environment Soft Skills: Effective analytical and communication skills (both verbal and written) Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Collaborative, with a focus on achieving team goals What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

About Amgen 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. Sr Validation Engineer What you will do 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 genetic data to push beyond what’s known today. In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The Senior Validation Engineer will oversee strategies and documents related to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions. The candidate should have prior experience with qualification of the following modalities, primarilysynthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP. Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will includetech transfers, new product introductions, and ongoing validation maintenance activities. Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. Aseptic processing system oversight (media fill, autoclave validation, EM) Prepare materials/documents (playbooks) for topics to be presented during audits/inspections Perform validation change control assessments Review/approve validation deviations Review/approve Master Batch Records Perform Person in Plant activities as required Escalate issues to Validation/Quality management, as needed Author Validation sections of Marketing Applications Write/review responses to regulatory questions (RTQs) Drive Operational Excellence and Champion Change Authority: Determine outcome of validation activities Decision to approve or reject validation documentation Provide input on Validation position on related topics and strategy for the site Decision to approve Master batch Records This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor’s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field. Functional Skills: Must-Have Skills: Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. Relevant experience in qualification of finished drug product and packaging processes. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Working foundation in cleaning validation and aseptic process simulation.Experience in resolving complex deviations associated with validation studies. Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations that comprise a robust Validation package. 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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Medical Review Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products To support global individual case safety reports regulatory reporting compliance To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports To act as a significant point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Support MSRT product lead if assigned Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support MSRT Product Lead activities for the list of expected terms in the auto label tool Support Quality Assurance of ICSR medical review (if applicable) Support training to vendor staff (if applicable) on ICSR medical review Mentor junior medical reviewers. Participate in Safety Assessment Team (SAT) (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 3 years of related drug safety experience Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including the Amgen Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post marketing environments Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 4 years relevant work What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Medical Review Senior Associate Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. Responsibilities: To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support Quality Assurance of ICSR medical review (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 1 year of related drug safety experience Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including Safety Database and medical coding Knowledge of safety data capture in Clinical Trials and Post Marketing setting Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 3 years of relevant work What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master’s degree OR Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you are 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. What you will do Let’s do this. Let’s change the world. In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs). Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Job Summary The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event. This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures. Key Activities Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete. Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system. Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures. Supports performance emphasized culture. Ensures quality of PC, AE and OSF records. Implements Standard Operating Procedure requirements for the triage process. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Education & Experience (Basic) Master’s degree and 3 years of Drug Safety or Life Sciences experience OR Bachelor’s degree and 5 years of Drug Safety or Life Sciences experience Education & Experience (Preferred) Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry Bachelor’s Degree in a health-care subject area or scientific field Previous experience with a corporate intake system or safety database Ability to successfully manage workload to strict timelines Familiarity with basic project management tools Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

What you will do Let’s do this. Let’s change the world. In this vital role you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles & Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) May provide functional area input for Global Regulatory Plan and team goals May work with contract and freelance writers May participate in training and mentoring of junior medical writers May participate in departmental and cross-departmental initiatives, as appropriate. Generate document timelines, with team input Keep abreast of relevant professional information and technology What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of directly related experience OR Bachelor’s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Functional Skills: Proficiency with word processing and other Microsoft Office Programs Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds; Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions; Understanding and application of principles, concepts, theories and standards of scientific/technical field. Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance’s and requirements. Soft Skills: Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

What you will do Let’s do this. Let’s change the world. In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Ensures quality of complaint records Applies analytical abilities to evaluate complex situations using multiple sources of information Execution of regulatory and SOP requirements Anticipates and prevents potential issues with regulators Provides guidance and technical advice Evaluates subject matter expert assessments Raises potential Quality issues to Management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR , Master’s degree and 4 to 6 years of Specialist Quality Complaints experience OR , Bachelor’s degree and 6 to 8 years of Specialist Quality Complaints experience OR , Diploma and 10 to 12 years of Specialist Quality Complaints experience Preferred Qualifications: Quality and manufacturing experience in biotech or pharmaceutical industry Ability to oversee multiple projects simultaneously Ability to successfully handle workload to timelines Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Adaptable and flexibleAgility for quick learningAbility to work well in a team Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing