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2.0 - 5.0 years
7 - 11 Lacs
Bengaluru
Work from Office
Job Title: Technical Writer Location: Bengaluru(Hybrid) At Reltio , we believe data should fuel business success. Reltio s AI-powered data unification and management capabilities encompassing entity resolution, multi-domain master data management (MDM), and data products transform siloed data from disparate sources into unified, trusted, and interoperable data. Reltio Data Cloud delivers interoperable data where and when its needed, empowering data and analytics leaders with unparalleled business responsiveness. Leading enterprise brands across multiple industries around the globe rely on our award-winning data unification and cloud-native MDM capabilities to improve efficiency, manage risk and drive growth. At Reltio, our values guide everything we do. With an unyielding commitment to prioritizing our Customer First , we strive to ensure their success. We embrace our differences and are Better Together as One Reltio. We are always looking to Simplify and Share our knowledge when we collaborate to remove obstacles for each other. We hold ourselves accountable for our actions and outcomes and strive for excellence. We Own It . Every day, we innovate and evolve, so that today is Always Better Than Yesterday . If you share and embody these values, we invite you to join our team at Reltio and contribute to our mission of excellence. Reltio has earned numerous awards and top rankings for our technology, our culture and our people. Reltio was founded on a distributed workforce and offers flexible work arrangements to help our people manage their personal and professional lives. If you re ready to work on unrivaled technology where your desire to be part of a collaborative team is met with a laser-focused mission to enable digital transformation with connected data, let s talk! Job Summary: As a Technical Writer, you ll create clear, concise, and user-focused documentation for Reltio s data and API platforms helping users confidently adopt AI-driven features and data services Job Duties and Responsibilities: Write and maintain product docs, API guides, and release notes for cloud-based apps and developer tools Translate complex technical concepts into simple, actionable language Document AI-based workflows and automation tools used across the platform Collaborate with engineers, product managers, and designers to improve UX through content Apply Reltio s editorial and DITA standards for consistent and structured output Improve docs using feedback, metrics, and AI insights Support content creation for tutorials, how-to videos, and UI-integrated help Skills You Must Have: 2 to 5 years of technical writing experience, preferably in enterprise SaaS or cloud platforms Strong writing and editing skills; ability to explain technical concepts clearly for diverse audiences Familiarity with AI/ML terminology and experience documenting AI-driven features or tools Hands-on knowledge of DITA, XML, or structured authoring Experience with tools like Oxygen XML, Confluence, Jira, Acrolinx, Snagit, Captivate, or Videate Ability to work independently in a fast-paced, remote-friendly environment Bonus: Exposure to AI-powered authoring workflows or content intelligence platforms Bachelors/Masters degree relevant to functional area or equivalent experience. DITA/XML structured/topic-based authoring DITA/XML authoring tools (oXygen XML, XMetal, or similar) CCMS (Heretto, Ixiasoft, Paligo, or similar) Editorial style guides (Microsoft Writing Style Guide, Chicago Manual of Style, or similar) Software as a Service (SaaS), server/systems management, networking technologies, and /or cloud computing Skills That Are Nice to Have: Issue and project tracking software (Confluence, JIRA, Zendesk, or similar) Code documentation tools (Swagger, JavaDoc, JSON, or similar) Style governance software (Acrolinx, Grammarly, or similar) Federated search software (SearchUnify, Coveo, or similar) Why Join Reltio At Reltio, we believe that taking care of our employees is key to their success and well-being. Here s why you should join our team: Health & Wellness : Comprehensive Group medical insurance including your parents with additional top-up options. Accidental Insurance Life insurance Free online unlimited doctor consultations An Employee Assistance Program (EAP) Work-Life Balance : 36 annual leaves, which includes Sick leaves 18, Earned Leaves - 18 26 weeks of maternity leave, 15 days of paternity leave Very unique to Reltio - 01 week of additional off as recharge week every year globally Support for home office setup : Home office setup allowance. Stay Connected, Work Flexibly: Mobile & Internet Reimbursement No need to pack a lunch we ve got you covered with free meal. And many more .. Reltio is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Reltio is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities.
Posted 5 days ago
3.0 - 8.0 years
5 - 9 Lacs
Pune
Work from Office
Project Role : Business Function Implement Practitioner Project Role Description : Support the implementation of activities for a specific business function to improve performance for a function end to end. Activities include analyzing and designing/re-designing business processes and/or defining parts of an organization. Must have skills : Infor M3 Process Manufacturing & Distro, Technical Writing Good to have skills : Technical DocumentationMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Function Implement Practitioner, you will support the implementation of activities for a specific business function aimed at enhancing overall performance. A typical day involves collaborating with various stakeholders to analyze current business processes, identifying areas for improvement, and designing or redesigning processes to optimize efficiency. You will engage in discussions to gather insights, facilitate workshops, and document findings to ensure that the proposed changes align with organizational goals. Your role will also require you to monitor the implementation of these processes, ensuring that they are effectively integrated into the business function. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Facilitate workshops and meetings to gather requirements and feedback from stakeholders.- Develop and maintain comprehensive documentation of business processes and changes. Professional & Technical Skills: - Must To Have Skills: Proficiency in Infor M3 Process Manufacturing & Distro, Technical Writing.- Good To Have Skills: Experience with Technical Documentation.- Strong analytical skills to assess business processes and identify improvement opportunities.- Ability to communicate complex ideas clearly and effectively to diverse audiences.- Experience in process mapping and redesign methodologies. Additional Information:- The candidate should have minimum 3 years of experience in Infor M3 Process Manufacturing & Distro.- This position is based at our Pune office.- A 15 years full time education is required. Qualification 15 years full time education
Posted 5 days ago
15.0 - 20.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Project Role : Engineering Services Practitioner Project Role Description : Assist with end-to-end engineering services to develop technical engineering solutions to solve problems and achieve business objectives. Solve engineering problems and achieve business objectives using scientific, socio-economic, technical knowledge and practical experience. Work across structural and stress design, qualification, configuration and technical management. Must have skills : Aircraft Illustrated Parts Catalogue Authoring Guidelines Good to have skills : Aircraft MaintenanceMinimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Engineering Services Practitioner, you will assist with end-to-end engineering services to develop technical engineering solutions that address complex challenges and meet business objectives. Your typical day will involve collaborating with cross-functional teams, analyzing engineering problems, and applying scientific and technical knowledge to create effective solutions. You will engage in discussions to share insights and contribute to the overall success of projects, ensuring that all engineering tasks align with organizational goals and standards. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Engage in continuous learning to stay updated with industry trends and best practices.- Assist in the documentation and presentation of engineering solutions to stakeholders.- Creation/modification/revision of the manual content for the IPC.- Should be well versed with the Authoring & proofreading process and standards.- Should have knowledge of Aerospace tech data process.- Should have good understanding on IPC configuration management.- Knowledge on Cabin ATA25 and LMP processing would be an added advantage.- Knowledge on ATA iSpec 2200 and S1000D standards.- Analyzing and interpretation of engineering drawings.- Should have Aircraft and systems knowledge.- Excellent Written and Verbal Communication Skills- Should be capable of conducting training/knowledge sharing session to team. Professional & Technical Skills: - Must To Have Skills: Proficiency in Aircraft Illustrated Parts Catalogue Authoring Guidelines.- Strong understanding of engineering principles and practices.- Experience with technical documentation and reporting.- Ability to analyze and interpret engineering data effectively.- Familiarity with aircraft maintenance processes and standards.-2 to 5 years of experience in Aerospace Technical Publications.-Creation/modification/revision of the manual content for the IPC.-Candidate currently performing Proofreading activity will be preferred.- Should have knowledge of Aerospace Tech Data process.- Knowledge on ATA iSpec 2200 and S1000D standards.- Analyzing and interpretation of engineering drawings.- Should have Aircraft and systems knowledge. Working knowledge of LMP activities will be additional advantage. Additional Information:- The candidate should have minimum 2 years of experience in Aircraft Illustrated Parts Catalogue Authoring Guidelines.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education
Posted 5 days ago
0.0 - 5.0 years
3 - 8 Lacs
Nashik
Work from Office
We are seeking a talented and creative Content Writer to join our dynamic marketing team. As a Content Writer, you will be responsible for creating engaging and informative content to promote our company's products. The ideal candidate should have a strong understanding of technology, excellent writing skills, and the ability to translate technical information into compelling and accessible content. ( Freshers with very good communication skills can also apply) Responsibilities: Content Creation: Develop high-quality and engaging content for various channels, including blog posts, website content, product descriptions, case studies, and whitepapers. Collaborate with product managers, developers, and other stakeholders to gather information and insights for content creation. Content Calendar Management: Develop and maintain a content calendar to ensure a consistent flow of content aligned with marketing and product release schedules. Editing and Proofreading: Review and edit content to ensure it meets high-quality standards, including grammar, style, and brand guidelines. Collaboration: Work closely with the marketing team, graphic designers, and other departments to ensure cohesive and effective content delivery. Market Research: Stay informed about industry trends, competitor activities, and customer preferences to create content that resonates with our target audience. Qualifications: Exceptional writing, editing skills, with a keen eye for detail. Ability to think creatively and generate original ideas. Strong communication and collaboration skills, with the ability to work effectively in a team environment. Timings: Flexible timings Weekly off: Saturday and Sunday Salary No Bar For Right Candidate
Posted 5 days ago
2.0 - 5.0 years
8 - 13 Lacs
Bengaluru
Work from Office
We are looking for a highly skilled and experienced Engineer 1 to join our team at J C Penney Services India Pvt Ltd, located in the Retailing industry. The ideal candidate will have a strong background in engineering and excellent problem-solving skills. Roles and Responsibility Collaborate with cross-functional teams to design and develop new products and systems. Conduct research and analysis to identify areas for improvement and implement changes. Develop and maintain technical documentation and reports. Provide technical support and training to junior engineers and technicians. Participate in code reviews and ensure compliance with industry standards. Troubleshoot and resolve complex technical issues efficiently. Job Requirements Bachelor's degree in Engineering (B.Tech/B.E.) or equivalent. Strong understanding of retail industry operations and processes. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills. Familiarity with industry-standard software and tools.
Posted 5 days ago
4.0 - 9.0 years
9 - 11 Lacs
Pune
Work from Office
Role Overview: We're seeking a skilled Content Strategist with expertise in cloud computing and technical content creation. You will strategize, plan, and execute compelling content tailored for multiple platforms including social media, LinkedIn, Reddit, our website, guest blogs, newsletters, and press releases. Key Responsibilities: Develop and implement content strategies for CloudPe across various digital channels. Create and manage engaging technical content related to cloud hosting, infrastructure solutions, and industry trends. Craft tailored content optimized for different platforms: Social Media (Instagram, Twitter, Facebook), LinkedIn professional posts, Reddit community engagement, and website blogs/articles. Produce press releases and manage distribution strategies to amplify brand awareness. Coordinate guest blog posts to enhance external visibility and authority. Collaborate with internal teams (marketing, technical) to ensure consistent messaging and brand voice. Analyze content performance metrics to refine and optimize future content initiatives. Required Skills: Proven experience (4+ years) in technical writing, specifically within cloud hosting, IT infrastructure, or SaaS industry. Demonstrable expertise in content planning for diverse digital channels. Strong proficiency in keyword research tools and SEO practices. Exceptional writing, editing, and communication skills. Ability to distill complex technical concepts into clear, compelling narratives for different audiences. Strategic thinker capable of planning and executing cohesive content campaigns.
Posted 5 days ago
4.0 - 12.0 years
14 - 18 Lacs
Hyderabad
Work from Office
Career Category Regulatory Job Description Career Category: Regulatory Job Description Let s do this. Let s change the world. In this vital role you will 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. The [vital attribute] professional we seek is a [type of person] with these qualifications. 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 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 .
Posted 5 days ago
0.0 - 5.0 years
2 - 3 Lacs
Navi Mumbai
Work from Office
Eligibility Criteria: - B.E/ B.Tech (Graduate) / Mechanical, Chemical, Electrical, Production, Mechatronics, Automation. BSc / MSc (Biotechnology, Biochemistry, Physics, Chemistry) Fixed Sat-Sun off Pick Up & Drop Available HR Nasreen - 8879637583
Posted 5 days ago
10.0 - 14.0 years
0 Lacs
kakinada, andhra pradesh
On-site
The primary purpose of this role is to ensure the safety and integrity of process systems by leading and facilitating various safety studies such as HAZOP, HAZID, SIL and LOPA. You will be responsible for conducting risk assessments, participating in incident investigations, and performing safety audits to identify and mitigate process safety hazards. Additionally, you will provide technical expertise, train plant personnel, and ensure compliance with safety procedures to safeguard operational excellence. Your key accountabilities will include knowledge and experience on studies like HAZOP, HAZID, SIL, LOPA for process systems, participation in Management of Change, Risk Assessment, and PSSR, performing Dispersion Analysis using PHAST, leading Plant Process Safety Audits, understanding P&IDs concerning various equipment, instruments, and processes, conducting logic and interlocks review, facilitating the identification, evaluation, and mitigation plan for process safety hazards, training plant personnel on Process Safety procedures, and technical evaluation of vendor specifications for process safety items and equipment. You should have strong analytical skills to assess technical information and identify safety risks effectively. Excellent communication and interpersonal skills are crucial for engaging with stakeholders at all levels. Certification in process safety management is required, along with proficiency in relevant software tools and technologies for data analysis and risk assessment. To qualify for this role, you should hold a Bachelor's degree in Chemical Engineering, Safety Engineering, or a related field, with an advanced degree being preferred. A minimum of 10 years of experience in operations/process safety in oil & gas, petrochemical, or similar industries is necessary, along with proven experience in process safety management within these industries. If you are interested in this opportunity, please email your application to enpcareers.hr@ril.com.,
Posted 6 days ago
6.0 - 10.0 years
0 Lacs
bhubaneswar
On-site
You should have a minimum of 6-9 years of experience as a Salesforce Lead Developer, with a strong understanding of Salesforce architecture and deep expertise in Lightning Web Components (LWC) and Apex development. You must have a proven track record of successfully completing multiple end-to-end greenfield implementations on the Salesforce platform. Your expertise should extend to designing and implementing complex Salesforce-based solutions, including customization, configuration, and integration with third-party systems. It is essential to stay updated on emerging technology trends and be able to contribute to and influence best practices within the discipline. You should have master-level proficiency in programming languages such as JavaScript, Apex, and Python. Experience with data migration and integration tools, particularly MuleSoft, is highly advantageous. Possessing Salesforce certifications, such as Salesforce Certified Technical Architect or Salesforce Certified Application Architect, would be highly desirable. Your knowledge and experience should cover Salesforce.com development, designing and delivering intricate business solutions on the Force.com platform, and expertise in all aspects of 2GP managed packages, Sales and Service Cloud, as well as various technology stacks outside of Salesforce.com to support integrations and other Salesforce ecosystem managed packages. You should be familiar with diverse integration patterns and have a track record of building highly scalable integrations with various systems using MuleSoft or other middleware technologies. Significant experience in implementing the Lightning Framework, Lightning Components, Lightning App Builder, and the Lightning Design System is required. Strong technical writing skills are necessary for solution illustration, proposals, and contract documentation. You should also possess exceptional problem-solving abilities to articulate complex issues and solutions in a clear, visual, and impactful manner.,
Posted 6 days ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
As a Technical Writer, you will collaborate with cross-functional teams to understand product specifications, user requirements, and technical processes. Your responsibilities will include researching, writing, editing, and proofreading technical documentation such as user manuals, guides, tutorials, API documentation, release notes, and online help. You will organize and maintain documentation repositories to ensure easy access and version control. Additionally, you will map product roadmap and requirements to functional sprints and track daily progress against sprints. Working closely with product managers, engineers, and designers, you will ensure documentation accuracy and completeness. You will be responsible for developing and maintaining a style guide and documentation templates to ensure consistency across all materials. Gathering feedback from users and stakeholders to continuously improve documentation quality and usability will be an essential part of your role. You will also keep up-to-date with industry trends and best practices in technical writing and documentation tools. To be successful in this role, you should have a Bachelor's degree in English, Technical Communication, Computer Science, or related field. Proven experience as a technical writer with a portfolio showcasing various types of technical documentation is required. Strong writing, editing, and proofreading skills with keen attention to detail are essential. Proficiency in using documentation tools such as Adobe Technical Communication Suite, MadCap Flare, Microsoft Word, Markdown, and version control systems like Git is necessary. You should have the ability to quickly grasp complex technical concepts and translate them into clear and concise documentation for both technical and non-technical audiences. Excellent communication and interpersonal skills are important for effective collaboration with cross-functional teams. Familiarity with Agile development methodologies and project management tools like Jira will be beneficial. While experience with software development or technical support is preferred, it is not required for this role.,
Posted 6 days ago
5.0 - 9.0 years
0 Lacs
karnataka
On-site
The Risk Analytics, Modeling and Validation role involves the development, enhancement, and validation of methods for measuring and analyzing all types of risks, including market, credit, and operational. In areas related to credit risk, individuals in this role develop, enhance, and validate models for measuring obligor credit risk, or early warning tools that monitor the credit risk of corporate or consumer customers, besides being involved in Loss Given Default studies. They also develop and maintain key risk parameters like default and rating migration data, usage given default data and transition matrices. This role is vital to the company as it provides a scientific and systematic approach to assessing and mitigating risks, thereby ensuring the company's financial stability, protecting its assets, and supporting its overall business strategy. The responsibilities of a Model Validator include performing model validations, annual model reviews, ongoing monitoring reviews (on Low and Medium Model Risk Rating (MRR) models) and model limitation remediation reviews for one or more model / product types under the supervision of a Validation Lead (VL). The role also involves providing effective challenge to the model development process, evaluating testing approach and results for individual models, assessing ongoing performance monitoring of the models, contributing to regulatory and internal audit related responses, collaborating with other teams within Risk and the Business, assisting with preparing reports and meeting materials, and supporting the process of designing, developing, delivering, and maintaining best-in-class qualitative model validation process standards. The ideal candidate for this role should have 5-8 years of experience in Quantitative Finance, Risk management, Analytics, Model Development or Model Validation. They should possess excellent partnership and teamwork skills, ability to formulate findings clearly and concisely in written form, good verbal communication skills, good analytic and creative thinking abilities, adept at analysis and documentation of results, ability to multi-task and work well under pressure, and deliver results under tight deadlines. Proficiency in programming languages like Python, MATLAB, C/C++/C#, VBA or other coding languages is required, along with knowledge of financial markets and products. Qualitative or quantitative model risk management experience is a plus, along with strong technical skills in time series analysis, statistics, and econometrics. Education requirement for this role is a Master's degree. Key skills required include Analytical Thinking, Business Acumen, Credible Challenge, Data Analysis, Governance, Policy and Procedure, Policy and Regulation, Risk Controls and Monitors, Risk Identification and Assessment, and Statistics. If you are a person with a disability and need a reasonable accommodation to use the search tools and/or apply for a career opportunity, please review Accessibility at Citi. View Citis EEO Policy Statement and the Know Your Rights poster for more information.,
Posted 6 days ago
2.0 - 7.0 years
4 - 9 Lacs
Hyderabad
Work from Office
The Sr. Associate QA position will implement internal collaboration with Amgen s global quality teams, manufacturing sites, commercial supply chains, Amgen affiliates, warehouses, and external logistic partners in various regions and countries. The role will support right-first-time quality systems activities, a resilient supply network, leverage compliance knowledge, and support continuous improvement initiatives. This role will also be a critical link between cross-functional teams to uphold the integrity and reliability of our quality standards Roles and Responsibilities: Primarily Perform the QA Contact role on the Product complaint and Distribution Complaint records and support other QMTS records such as Quality Events, Change Control records, Clinical and Commercial Temperature Excursion records, Corrective and Preventive Actions, effectiveness verification, and documentation. Manage quality records, including those for complaints, product recalls, and returned goods, ensuring they meet regulatory and organizational standards. Support audits, including self-inspections and external vendor audits, ensuring compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). Demonstrate knowledge of key regulatory guidelines, including c GDP and cGMP for pharmaceutical/ device products. Understand and incorporate risk management strategy into the overall supply chain strategy Ensure accurate, complete, and timely documentation of quality records, including deviations, CAPA, change controls, and audit findings. Develop quality reports and metrics to track key performance indicators (KPIs) related to quality assurance and compliance. Identify and lead initiatives for process improvement, driving quality and operational efficiency through structured methodologies. Collaborate with cross-functional teams to implement best practices in quality assurance processes, ensuring continuous improvement. Participate in training sessions for quality and compliance, promoting an organizational culture of quality excellence Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs. Education and Experiences: We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelors degree in science or engineering and 2+ years of professional experience in related fields. Understanding of GMP/GDP requirements. Familiarity with logistics processes of parcel, transport, and warehousing providers. Experience in final release and QMTS processes in global markets Strong technical writing skills. Preferred Qualifications: Strong continuous improvement mindset and lean practices experience. Understanding of end-to-end supply chain business processes. Experience in project management across multiple departments and geographies. Quick process understanding, insight, and visualizing. Strong analytical and problem-solving skills. Independent self-starter, able to work autonomously, under pressure, and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail-oriented, and highly motivated with a can do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools, including Excel, Word, and PowerPoint. Ability to multi-task and prioritize
Posted 6 days ago
1.0 - 3.0 years
14 - 15 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you willbe serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organisations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. In this role you will be part of Amgen s Global Supply Quality team supporting oversight and maintenance of contract manufacturers. Roles & Responsibilities: Working independently, the individual will be responsible for, but not limited to the following: Enter analytical into LIMS Create and update LIMS sample plans Generate Certificate of Analysis Compile batch release documentation Perform QA Approver role on the Quality Events Initiate Quality records for supplier related changes Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Take part in operational and quality improvement initiatives, programs, and projects. Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs. This role may require working in shifts or extended hours within the same shift to support global timezones. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master s degree and 1 to 3 years of professional experience in related fields OR Bachelor s degree and 3 to 5 years of professional experience in related fields OR Diploma and 7 to 9 years of professional experience in related fields Understanding GMP/GDP requirements. Familiarity with raw material compendial testing Experience overseeing quality of suppliers or external parties Strong technical writing skills Preferred Qualifications: Experience and strong familiarity with digital tools and computerized systems. Strong continuous improvement attitude and lean practices experience. Understanding of end-to-end supply chain business processes. Experience in project management across multiple departments and geographies. Quick process understanding, insight and visualizing. Strong analytical and problem-solving skills. Independent self-starter, able to work autonomously, under pressure and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail oriented, highly motivated with a can do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. Ability to multi-task and prioritize Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams 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.
Posted 6 days ago
2.0 - 7.0 years
1 - 5 Lacs
Hyderabad
Work from Office
The Sr Associate Supplier Quality position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen multi-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process development, and supply chain. Role Description Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Collaborate with raw material suppliers to ensure alignment to quality agreements, identifying performance improvement opportunities Understand and incorporate risk management strategy into the overall raw material lifecycle Provide support to the supplier periodic monitoring oversight activities Support in tactical activities related to internal/external audits and inspections Perform routine quality assessments and provide approval of changes to raw material inspection profiles Take part in operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships Work under minimal supervision in line with Amgen Values and Leadership Attributes What we expect of you Education and Experiences: We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelor s degree in science or engineering and 2+ years of professional experience in related fields Understanding of GMP/GDP requirements Familiarity with raw material compendial testing Experience overseeing quality of suppliers or external parties Deep technical writing skills Preferred Qualifications Strong continuous improvement approach and lean practices experience Understanding of end-to-end supply chain business processes Experience in project management across multiple departments and geographies Quick process understanding, insight and visualizing Strong analytical and problem-solving skills Independent self-starter, able to work autonomously, under pressure and in teams GMP/GDP knowledge and understanding of pharmaceutical regulations Energetic, detail oriented, highly motivated with a can do outlook Change management skills Ability to communicate across all levels of the organization Effective written and verbal communication skills Experience with Microsoft Office Tools including Excel, Word, and PowerPoint Ability to multi-task and prioritize 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.
Posted 6 days ago
1.0 - 3.0 years
9 - 13 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will The Sr. Associate QA position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen cross-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process development, and supply chain. Responsibilities : Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Collaborate with raw material suppliers to ensure adherence to quality agreements, identifying performance improvement opportunities Understand and incorporate risk management strategy into the overall raw material lifecycle Provide support to the supplier periodic monitoring oversight activities Support in tactical activities related to internal/external audits and inspections Perform routine quality assessments and provide approval of changes to raw material inspection profiles Take part in operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Work under minimal supervision in line with Amgen Values and Leadership Attributes. This role may require working in shifts or extended hours within the same shift to support global timezones. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master s degree and 1 to 3 years of professional experience in related fields OR Bachelor s degree and 3 to 5 years of professional experience in related fields OR Diploma and 7 to 9 years of professional experience in related fields Understanding of GMP/GDP requirements. Familiarity with raw material compendial testing Experience overseeing quality of suppliers or external parties Strong technical writing skills Preferred Qualifications: Experience and strong familiarity with digital tools and computerized systems. Strong continuous improvement approach and lean practices experience. Understanding of end-to-end supply chain business processes. Experience in project management across multiple departments and geographies. Quick process understanding, insight and visualizing. Strong analytical and problem-solving skills. Independent self-starter, able to work autonomously, under pressure and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail oriented, highly motivated with a can do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. Ability to multi-task and prioritize 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.
Posted 6 days ago
2.0 - 7.0 years
4 - 9 Lacs
Hyderabad
Work from Office
We are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team. HOW MIGHT YOU DEFY IMAGINATION? You ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you ve worked hard to acquire and the passion you already have. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this relevant role. Role Description The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgen s Global Supply Hubs to Amgen s global markets, and provide QA oversight of QA activities for Global Supply Chain operations. This role may require working in shifts or extended hours within the same shift. Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation, as well as QA triage of Distribution complaints. Work closely with all relevant collaborators for the end-to-end process and ensure compliance to GMP/GDP. Act as subject matter expert (SME) for transportation related Quality Processes Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Collaborate with the 3rd Parties to ensure adherence to service levels, identifying and implementing performance improvement Understand and incorporate risk management strategy into overall supply chain strategy Provide support for logistic service provider and transportation service provider oversight Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team Provide quality expertise and guidance to operational staff and within cross functional Amgen teams Take part in operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Work under minimal supervision in line with Amgen Values and Leadership Attributes What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelor s degree in science or engineering and 2+ years of professional experience in related fields. Understanding of GMP/GDP requirements. Familiarity with logistics processes of parcel, transport, and warehousing providers. Experience in Validation/Qualification of processes, equipment, and facilities. Strong technical writing skills. Preferred Qualifications: Strong continuous improvement attitude and lean practices experience. Understanding of end-to-end supply chain business processes. Experience in project management across multiple departments and geographies. Quick process understanding, insight and visualizing. Strong analytical and problem-solving skills. Independent self-starter, able to work autonomously, under pressure and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail oriented, highly motivated with a can do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. Ability to multi-task and prioritize 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.
Posted 6 days ago
2.0 - 7.0 years
10 - 13 Lacs
Hyderabad
Work from Office
We are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team. The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgen s Global Supply Hubs to Amgen s global markets, and provide QA oversight of QA activities for Global Supply Chain operations. Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, as well as QA triage of Distribution complaints. Work closely with all relevant partners for the end-to-end process and ensure compliance to GMP/GDP. Act as subject matter expert (SME) for transportation related Quality Processes Collaborate with the 3rd Parties to ensure alignment to service levels, identifying and implementing performance improvement Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Understand and incorporate risk management strategy into overall supply chain strategy Provide support for logistic service provider and transportation service provider oversight Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team Provide quality expertise and guidance to operational staff and within multi-functional Amgen teams Take part in operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Work under minimal supervision in line with Amgen Values and Leadership Attributes What we expect of you Basic Qualifications and Experience We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelor s degree in science or engineering and 2+ years of professional experience in related fields. Understanding of GMP/GDP requirements. Familiarity with logistics processes of parcel, transport, and warehousing providers. Experience in Validation/Qualification of processes, equipment, and facilities. Deep technical writing skills. Independent self-starter, able to work autonomously, under pressure and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail oriented, highly motivated with a can do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. Ability to multi-task and prioritize 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.
Posted 6 days ago
4.0 - 6.0 years
8 - 12 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will be responsible for leading and charting the course for the Quality Control technology product team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a very hardworking team that is built for delivering high-end and innovative technologies. The ideal candidate will have a proven track record of leadership in technology-driven environments for the Quality Control area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a solid background in end-to-end software development and Quality Control Platforms, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational pivotal initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Maintain strategic relationships and good communication with the leadership team about IS services and service roadmaps to ensure that all the partners feel informed and engaged Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle Develop and implement strategic plans for technology and workforce. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Attract and recruit top talent as part of an extensive Technology organization to be hired within India. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and stakeholders Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate standard methodology sharing, ensuring ongoing alignment with the Technology & Digital strategy Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy What we expect of you We are all different, yet we all use our unique contributions to serve patients. The vital attribute in a professional we seek with these qualifications Basic Qualifications: Master s degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field Preferred Qualifications: Must-Have Skills Demonstrated experience in handling technology initiatives and teams with a track record of successful innovation Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Must be flexible and able to handle multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively handle collaborator relationships and build new partnerships. Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc. GMP and Validation Experience on Pharmaceutical / Regulated Industry Experience with Managing Quality Control Platforms on a Global Enterprise Environment Have good eye for business. Can demonstrate deep understanding of industry, therapy and product Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Knowledge on Investigational Methodologies and Technical Writing Proficiency Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. 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. Excellent analytical and fix skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams 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.
Posted 6 days ago
1.0 - 3.0 years
2 - 5 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. 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.
Posted 6 days ago
4.0 - 6.0 years
13 - 17 Lacs
Hyderabad
Work from Office
Career Category Regulatory Job Description Career Category: Regulatory Job Description Let s do this. Let s change the world. In this vital role you will 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. The [vital attribute] professional we seek is a [type of person] with these qualifications. 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 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.
Posted 6 days ago
5.0 - 7.0 years
5 - 9 Lacs
Hyderabad
Work from Office
Roles and Responsibilities Experienced technical writer for writing reports, recommendations and detailed analysis of deeply technical subjects in a way that can be explained. Standard Technical Writer profile with 5-7 years experience as the base requirement. To be sourced from the experienced Tech Writer community in Services or Product firms. Experience in writing product manuals, creating write ups for client proposal etc Experience in helping the corporate communication team in writing blogs and other communication write ups. Prior experience in working on Tech Report authoring in AI space will be an added advantage. Qualifications Required Bachelors degree (or equivalent) in journalism, communications, or relevant technical field Firm understanding of SDLC (systems development lifecycle) Previous experience in software development Professional certification (ex: Society for Technical Communication) Experience in using XML tools to create documentation Skills and Experience Required We are seeking an experienced Technical Writer with 5-7 years of expertise in crafting clear, concise, and comprehensive documentation for complex technical subjects. The ideal candidate will have a strong background in writing technical reports, client proposals, and product manuals, with a flair for translating intricate technical concepts into accessible content for diverse audiences. This role requires collaboration across product, engineering, and corporate communication teams to produce high-quality reports, recommendations, blogs, and internal/external communication materials. Experience in authoring technical documents in the AI/ML space will be a significant advantage.
Posted 6 days ago
5.0 - 10.0 years
7 - 16 Lacs
Thane, Navi Mumbai, Mumbai (All Areas)
Work from Office
Location : Thane Role Overview: We are seeking a dynamic and meticulous professional to join our team as a QA & Technical Process Writer . This mid-management role is pivotal in ensuring the highest standards of quality across our payment systems while also documenting technical processes with clarity and precision. The ideal candidate will bring a strong understanding of the payments or fintech industry, a passion for quality, and the ability to collaborate across cross-functional teams. Key Responsibilities: Quality Assurance: Design, implement, and maintain QA processes and test strategies for payment systems and fintech products. Collaborate with product, engineering, and compliance teams to ensure product quality and regulatory adherence. Conduct root cause analysis and drive continuous improvement initiatives. Monitor key quality metrics and report on performance trends. Technical Process Writing: Create, maintain, and update detailed technical documentation, including process flows, SOPs, user manuals, and compliance documentation. Translate complex technical concepts into clear, concise, and user-friendly content. Collaborate with subject matter experts (SMEs), product managers, to gather information and validate content. Standardize and templatize SOPs and process documentation to ensure consistency, scalability, and ease of use across teams. Maintain version control and ensure timely updates to reflect process or policy changes. Ensure consistency in tone, formatting, and terminology across all documentation. Maintain and update documentation repositories to reflect product/process changes. Identify gaps in existing documentation and proactively recommend improvements. Organize and manage documentation repositories for easy access and retrieval. Support knowledge management initiatives by identifying content gaps and proposing improvements. Ensure documentation aligns with internal standards and regulatory requirements. Standardize and templatize SOPs and process documentation to ensure consistency, scalability, and ease of use across teams. Leadership Skills: Act as a bridge between Multiple functions, QA, Technology, product, and compliance teams. Engage with senior leadership to communicate quality insights and documentation strategies. Mentor junior team members and contribute to a culture of quality and knowledge sharing. Qualifications & Experience: Bachelors degree in computer science, Engineering, Information Systems, or a related field (Talent Acquisition can vet this) 610 years of experience in QA and/or technical writing, preferably in the payments or fintech domain. Strong understanding of payment systems, transaction flows, and regulatory frameworks (e.g., PCI DSS, ISO 20022). Proven experience with QA tools (e.g., JIRA, Selenium, Postman) and documentation platforms (e.g., Confluence, Markdown, Git). Key Competencies: Collaboration & Teamwork: Proven ability to work cross-functionally and build strong relationships across departments. Communication: Excellent written and verbal communication skills with the ability to engage with both technical and non-technical stakeholders. Clarity of Thought: Ability to distil complex processes into clear, actionable documentation. Eye for Detail: Meticulous attention to detail in both QA and documentation tasks. Quality Mindset: Passion for delivering high-quality products and continuously improving processes. Leadership Presence: Comfortable interacting with senior leaders and influencing decision-making. Why Join Us? Be part of a fast-growing fintech company shaping the future of digital payments. Work in a collaborative, innovation-driven environment. Opportunity to lead impactful quality and documentation initiatives.
Posted 6 days ago
6.0 - 10.0 years
12 - 13 Lacs
Mumbai
Work from Office
Currie & Brown is one of the leading International physical asset management and construction consultancies, dedicated to advising clients worldwide with our expertise and experience in multiple sectors and services. We are differentiated by our people, innovation and reputation with a genuine global office network. Our people, from the first-day apprentice to senior management make our business what it is today. Everybody in the Currie & Brown family, no matter how experienced they are, plays their own unique part in our success and have fun along the way. The role what is it we would like you to do Currie & Brown is currently looking for a Project Manager. Your core duties will involve: Support the project lead in managing the design and construction phases of the design and fit-out of multi-sited projects Liaise with multiple stakeholders from the client and customer teams including, property services, designers, contractors, FM and building management and security consultants. Lead the coordination of the design of the customer fit-out against the client s design guides and constraints. Delivering projects, commissions and professional assignments Assuming a leading role in setting objectives and priorities, working as a proactive team player Maintaining effective communication to ensure all information is available for the successful completion of projects; liaising with other managers to ensure efficient financial control Assisting with commercial management services Delivering all work outputs in an accurate and timely manner Providing support to the team leader/service leaders in cost management of projects Representing the company in a professional and diligent manner; meeting, negotiating and corresponding with clients to form strong working relationships What skills and attributes are we looking for from you: Technical delivery experience gained within the construction industry Good technical writing, client-facing and communication skills Well-organised, diligent, proactive, assertive, well-disciplined and commercially astute A team player with a can-do attitude, outgoing, polite, patient, diplomatic, personable, respectful and flexible BSc in construction management, architecture, building surveying or equivalent Experience in the education sector environment would be advantageous Experience of fit-out projects Risk management qualifications or experience About You About Us Why choose Currie & Brown Unlike some businesses, we prioritise for the long term and honour our commitments. We are compassionate and inclusive in the way we approach our work, and always look to invest in our people s futures. Be it a desire to work internationally, a drive to progress, or even a curiosity to operate in a new sector, we are there for our people at every stage providing advice, support and the structure to achieve. That is why so many of us have established and built successful careers here for so long. We don t offer just a job we offer a career with clear structured route to progression, and a track record of making international mobility happen with international moves encouraged on a permanent or secondment basis. We are an international industry leader Working for us provides the chance to work for a leading brand with a focus on excellence, being digitally-led in our approach, we present the chance to work on some of the world s most prestigious projects and for some of the world s top clients. We want you to be able to bring your best self to work everyday and that is why we firmly believe equality, diversity and inclusion should be fundamental in creating a successful work force. We offer comprehensive benefits packages in all our global regions which have been specifically tailored to offer additional rewards to our employees from entry level to senior executives.
Posted 6 days ago
2.0 - 5.0 years
8 - 12 Lacs
Pune
Work from Office
About the team and your role We are currently looking for integration consultants that are passionate about integration and understand what it takes to deliver TOP quality integration solutions to our clients and partners. You have an eagle-eye for identifying the integration challenges and the ability to translate those same business challenges into the best integration solutions. You can listen and stay calm under pressure and can be the linking pin between business and IT. You have seen integrations in different shapes, sizes, and colours, you can integrate any to any, either on-premise or cloud. You advise our clients about the best integration strategies based on best practices, analysts recommendations, and architecture patterns. Last but not least, to be successful in this position we expect you to apply your strong consultancy & integration skills. Part of your responsibilities is to support the different developing teams during the entire lifecycle of an interface, from requirements gathering, analysis, design, development, testing, and handing over to operational support. We are looking for experienced Enterprise Integration Consultants to join our team. The ideal candidate has: Strong knowledge of integration principles and consultancy skills to be able to translate business to IT requirements. Hands-on experience in the integration of SAP and non-SAP systems in A2A and B2B scenarios. Deep expertise and hands-on experience in Dell Boomi as the primary integration platform. Working knowledge of API Management platforms (e.g., SAP API Management, Apigee, or others). Familiarity with event-driven architecture and distributed streaming platforms like Solace or Confluent Kafka . In-depth technical, functional, and architectural expertise in integrating applications using different technologies such as but not limited to REST, SOAP, ALE-IDocs, EDI, RFC, XI, HTTP, IDOC, JDBC, File/FTP, Mail, JMS. Solid middleware knowledge and web service skills. Good understanding of REST API and Web Services. Extensive experience with integrating 3rd party applications using REST-based services. Experience using tools like Postman & SOAPUI for service testing. Proven experience with full life cycle Integration implementation or rollout projects. Demonstrated experience with deliverables planning, client-facing roles, and high pace environments. What is Rojo all about Founded in 2011, Rojo Integrations has transformed from a consulting firm into a comprehensive SAP integration leader, partnering with top software vendors like SAP, Coupa, SnapLogic, and Solace. As the leading SAP integration partner and ultimate expert, we provide seamless enterprise integration and data analytics solutions, enabling real-time insights and empowering digital transformation. Trusted by global Bluechip companies such as Heineken and Siemens, we deliver tailored services to meet unique business needs. Rojo is headquartered in the Netherlands and operates globally from its offices in the Netherlands, Spain, and India. We specialize in SAP integration modernization and business processes, improving data integration and business strategies. Our 360-degree portfolio includes consultancy, software development, and managed services to streamline integration, enhance observability, and drive growth. Requirements to succeed in this role Experience using Dell Boomi , SAP PO, SAP Cloud Integration, SnapLogic, and/or API Management. Quick Learner and adapt to the new tools and technologies and evaluate their test applicability. Team Player with good technical, analytical, communication skills and client-driven mindset. A bright mind and ability to understand a complex platform. Ability to understand technical/engineering concepts and to learn integration product functionality and applications. Demonstrated user-focused technical writing ability. Must be able to communicate complex technical concepts clearly and effectively. Strong analytical and problem-solving skills. Ability to work independently in a dynamic environment. Ability to work on multiple complex projects simultaneously. Strong interpersonal communication skills. Effectively communicates in one-to-one and group situations. At least three years of previous experience in a similar role. Additional desired skills: You have at least a Bachelor s degree in computer engineering or a related field. Experience with any API Management Platform. Experience with Distributed Streaming Platforms and Event-based Integration Architecture such as Kafka or Solace. Extensive experience in integration of SAP and non-SAP systems in A2A and B2B scenarios using SAP Integration Suite or Cloud Integration (CPI). Experience in integration with main SAP backend systems (SAP ERP, SAP S/4HANA, SAP S/4HANA Cloud). SAP PO experience in programming UDF s, Modules, Look-Ups (RFC, SOAP, JDBC), BPM, Inbound and Outbound ABAP Proxies. Extensive knowledge of Java, JavaScript and/or GroovyScript. Good understanding CI/CD concepts. Speak and write English fluently. Affinity and experience with integration platforms/software like Dell Boomi, SAP Cloud Integration, or SnapLogic is desirable. What do we offer The chance to gain work experience in a dynamic and inspiring environment and launch your career. Plenty growth opportunities while working in a high energy and fun environment. The opportunity to work on innovative projects with colleagues who are genuinely proud of their contribution. Training and mentoring to support your professional development with a yearly education budget. International atmosphere with Multicultural environments (+- 20 nationalities). A global, inclusive and diverse working climate within a world conscious organization. Plus, other exciting benefits specific to each region. Rojo is committed in achieving diversity & inclusion in terms of gender, caste, race, religion, nationality, ethnic origin, sexual orientation, disability, age, pregnancy, or other status. All qualified candidates are encouraged to apply. No one fits a job description perfectly, and there is no such thing as the perfect candidate. If you dont meet all the criteria, wed still love to hear from you. Does that spark your interestApply now.
Posted 6 days ago
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