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4.0 - 9.0 years

5 - 9 Lacs

Pune

Work from Office

Technical writing expert, preferably healthcare experience, with below expertise. •Schema ST4 •FrameMaker tool •Technical Writing Course completion •Simplified Technical English course completion •Style Guide knowledge •Understanding of Medical regulatory and compliances •Understanding of service and maintenance activities

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7.0 - 12.0 years

11 - 14 Lacs

Pune, Greater Noida

Work from Office

Job Title / Role: Duckcreek Policy Developer Key Skills: DuckCreek Policy, Author, Product Studio, Express, Server, User Admin, Policy Administration System, Anywhere API, Native API, Manuscript Coding & Integration Experience: 3-12 years Location: Greater Noida & Pune Mode: Hybrid Immediate joiners preferred We at Coforge are hiring DuckCreek Policy Developer with the following skillset: Candidate should have strong experience on Duckcreek. Candidate should have strong experience on Policy. Candidate should strong experience on Duckcreek Example Platform 6X & 7X. G ood understanding of underwriting, rating, insurance rules, forms. Good Knowledge of Policy life cycle and various Policy Transactions. Hands-on experience working in Example Author, Server, Express, Forms, Rating, Batch Processing, Task Creation, Transact, Address Validation. Good Knowledge of Duck Creek Policy System and workflow. Experience in P&C insurance domain. Good Knowledge of Manuscripts, data model, inheritance model and Forms Good Understanding of business, functional requirements and policy workflow of the total application and project. Understanding the client's requirement properly then going for the development in the core areas of DCT. Must have excellent Communication Skills.

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2.0 - 7.0 years

4 - 8 Lacs

Bengaluru

Work from Office

Roles & Responsibilities Will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department. will be responsible for regulatory submission process, including CT-NOC, marketing authorization applications, NOC & test license. will follow up with regulatory agencies to obtain the approvals to support the regulatory timelines will identify and assess regulatory risks associated with product filing. will provide regulatory guidance to company personnel throughout the research and development process. Competencies: Understanding of various regulatory requirements for new drug development Presentation & Communication Skills Interpersonal Skills Proficiency in Kannada Desired Profile : M. Pharm/M.Sc. with 2+ yrs of experience in submission of dossiers to Indian Regulatory agencies Working experience of IND and NDA filing of NCE and NBE products

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2.0 - 7.0 years

3 - 7 Lacs

Hyderabad, Pune

Work from Office

Roles & Responsibilities : Create technical documents (authoring & illustrations) such as Parts Manuals, User Manuals, Service Manuals, Repair Guides, Installation Instructions and technical specifications for automotive products and systems. Educational Qualification : • B.E/B.Tech/Diploma in Mechanical/Automobile/ProductionEngineering Required Skills: • 1-3 years of experience in developing the technical documents such as Parts Manuals, User Manuals, Service Manuals, Repair Guides, Installation Instructions and technical specifications for automotive products and systems. • Should be well-versed with Arbortext Editor, IsoDraw, CreoView, Windchill • Should have sound knowledge in automotive parts and their applications. • Should be able to understand Mechanical Drawings, 3D Models and Orthographic Projections. • Should be a quick learner and should be able to work independently with a minimum supervision. • Should have good communication skills

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8.0 - 13.0 years

12 - 16 Lacs

Chennai

Work from Office

Job Responsibilities: Technical author- Must have at least 8 years working experience in Aircraft Maintenance Manuals (AMM) tasks creation and revision preferably on Cabin and Systems ATA chapters. Have good understanding of the aircraft systems and components. Good understanding of aircraft maintenance procedures and documentation. Hands on experience on tools like SAP/GAMS, DACAS, A350 PC suite (PDM), Gipsy, Taksy, Epic Editor, Adobe Professional is an added advantage. Working Knowledge on TechPub Standards. (ATA, iSpec2200, S1000D) Strong Simplified English skills Will be involved in the creation/revision of A-350 AMM tasks based on the customer supplied inputs (MPMs, SBs, TRs etc.). Responsible to deliver the assigned tasks with quality and on time schedule compliance. Train and mentor new Resources. Make sure high Quality of deliverables and adherence to schedules. Experience in AMM creation / Revisions, Experience in Authoring / Proof Reading, and Quality Reviews. Soft Skills: Excellent skill requirement in Excel, Visio, PowerPoint, and MS word Good written and oral communication Strong teamwork skills. Technical Skills: Minimum 8yrs of working experience on Airbus manuals (A-350, SA, LR, MB AMM) especially on the following - ATA 21, 30, 35, 38- GE Local Line ATA 25-23/24-GE Local Line Trouble Shooting manual experience is preferred Qualification : Any Graduates Qualification: BE / Diploma / AME

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4.0 - 9.0 years

4 - 9 Lacs

Mumbai, Maharashtra, India

On-site

Roles & Responsibilities Service author/writer role & responsible for creating and updating for all JCB construction equipment and global products: Service & Operator Manuals Maintenance Manual & Repair Manual Service Bulletin and Illustrations Hydraulic & Electrical schematic experience Standard Maintenance practices, SOPs Capable to work with a team of diverse and talented individuals comprised of technical writers, technical Illustrators (IDC and UK). Drive proper technical data (text and illustrations) lifecycle, content reuse, and authoring processes using content management system (CMS). Coordinate with the Worldwide Service team to create and deliver the highest quality technical service literature. Responsible for a day-to-day deliverable of the service author to ensure on- time delivery. PROFILE Experience in technical writing (Service and Operator manual authoring). Service field experience Strong understanding of change notices (EPI & ECN) and engineering drawing reading capability Project Management experience SKILLSET Experience in Tools- Oxygen XML editor (XML or SGML equivalent), Content Management System (CMS), Adobe Framemaker - Photoshop - Illustrator. Knowledge of various style guides including Simplified Technical English (STE) and possess the ability to adhere to company specific style guides. Global Engineering tools PLM, UGNX and Team-center Visualization. Ability to work with the diverse team on multiple projects

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3.0 - 10.0 years

16 - 21 Lacs

Hyderabad

Work from Office

Principal Instructional Designer (Tech Content Strategist) – Cloud Job Overview Are you a certified Cloud professional with a creative flair and a passion for content design? Join us to create impactful, learner-centered content that blends real-world expertise with engaging storytelling. As a Principal Instructional Designer - Cloud, you will lead the end-to-end development of engaging, instructionally sound learning experiences across major cloud platforms and technologies. Acting as a subject matter expert (SME), you'll translate complex cloud architectures and concepts into clear, outcome-focused content across digital formats. This role demands strong instructional design expertise, a deep understanding of learner needs, and the ability to creatively script and plan high-impact learning assets—from video courses to hands-on labs and assessments. Job Responsibilities Own the content development lifecycle—plan, research, script, storyboard review, strategic video review, and iterate—for Cloud technologies including AWS, Azure, Google Cloud, and multi-cloud strategies. Design creative and effective learning experiences grounded in instructional design principles, addressing diverse learner personas and real-world cloud implementation scenarios. Author and script engaging digital content, including on-demand videos, interactive cloud labs, walkthroughs/lessons, assessments, and job aids. Collaborate with visual designers, editors, and cloud technical experts to bring content to life in a compelling and accessible format. Align content with industry certification frameworks (e.g., AWS Certified Solutions Architect, Azure Administrator, Google Cloud Engineer) and learner performance outcomes Apply learner-centered design by identifying learning gaps and tailoring content that improves retention, engagement, and job readiness for cloud professionals. Utilize Generative AI tools to accelerate and enhance content ideation, scripting, and personalization. Ensure instructional consistency, voice, and quality across all course deliverables and formats. Optionally support bootcamps (virtual training delivery) and mentor junior content developers Skills Required Minimum 8+ years of hands-on experience in cloud technologies, including practical exposure to content planning and development. Demonstrated experience in instructional design, especially in developing digital learning products from concept to delivery. Excellent scripting, writing, and communication skills; able to distil complex cloud concepts into concise, engaging narratives. Strong creativity and storytelling ability with an understanding of how to structure content for different learning styles. Experience working with cloud platforms and related tools (AWS, Azure, GCP, Terraform, CloudFormation). Relevant certifications in Cloud technologies (e.g., AWS Certified Solutions Architect, Azure Administrator, Google Cloud Engineer, CompTIA Cloud+). Preferred/Additional Skills: Familiarity with Generative AI tools like ChatGPT, Claude, or similar for content creation and enhancement. Training delivery experience (live/ virtual/ hybrid formats) in cloud technologies. Understanding of instructional design models such as ADDIE, SAM, or Bloom’s Taxonomy. Experience in analyzing learner feedback and improving content based on performance and engagement data. Leadership experience in directing cross-functional teams for comprehensive cloud learning programs.

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5 - 10 years

4 - 7 Lacs

Mumbai, Mumbai Suburban, Mumbai (All Areas)

Work from Office

Role & responsibilities Ensure smooth branch operations complying to all internal controls, regulatory and compliance requirements, thus leading to strong business growth and optimum level of customer satisfaction. Cash and Vault monitoring in branch Ensure adherence with laid down processes and controls and manage Operational Risk for the Branch. Ensure, manage and supervise over the counter services in the branch to achieve timely and accurate processing of customer requests transactions and customer complaints, while ensuring service delivery is as per the prescribed standards and SLAs between the functions of the bank. Adherence to agreed TATs with Business thereby ensuring customer satisfaction. Compliance with all regulatory and internal guidelines and policies Manage audit at Branch and always ensure minimum satisfactory rating. Ensure smooth functioning of the Branch by supervising activities relating to Facilities Management, IT, etc. at branch level. Manage & control all operational functions of the Branch and define roles and responsibilities clearly for all team members. Ensure adequate coordination with centralized operations teams to maintain high quality service and customer satisfaction. Ensure timely receipt and submission of regulatory and other reports by/from the Branch. Monitor SLAs with all the Central Operations units. Participate in all critical system enhancement and process improvement exercises within Trade & Operations. Identify areas where productivity enhancement and cost reduction initiatives can be introduced. Ensure all processes are performed as per bank policies to achieve best satisfactory audit ratings in internal, external and SBP audits. Lead the branch Operations team to set individual objectives, review performance appraisals and provide on-going feedback on a formal and informal basis so that all staff are aware of what they are required to achieve and how they are performing against their objectives. Ensure implementation of a transparent and effective KPIs setting and appraisal process in time with local and regional guidelines. Actively participate for retention of deposits, identify and follow up on cross sell leads along with the branch manager in order to strengthen the liability position of the bank Any other responsibilities as assigned by Head T&O from time to time Competency & Skills Required: Strong knowledge of banking regulations, SOPs, regulatory guidelines Strong written and oral communication skills Proven leadership skills, and the ability to coach staff to ensure high level of customer service Robust knowledge of branch banking operations Capacity for team building Maintain significant standard of services for Desired levels. Customer centric approach People management skills Please share your CV Regional HR Business Partner Mahesh Chowgule mahesh.chowgule@unitybank.co.in

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2 - 6 years

12 - 14 Lacs

Gurugram

Work from Office

Role: AEM Content Author Experience: 2+ Years Location: Gurgaon (5 days Work from Office) Joining: Immediate joiners preferred Key Responsibilities: Create, edit, and manage digital content using AEM Manage digital assets (images, videos, etc.) within the AEM platform Work closely with cross-functional teams including designers, developers, and marketing Ensure content adheres to SEO, UX, and accessibility standards Utilize AEM templates and workflows for consistent and scalable content delivery Required Skills: Strong hands-on experience in AEM authoring Basic knowledge of HTML/CSS Excellent communication and attention to detail Understanding of SEO and content strategies Good to Have: AEM certifications Familiarity with AEM workflows and tools like Jira

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2 - 5 years

10 - 13 Lacs

Noida, New Delhi, Gurugram

Work from Office

Role: AEM Content Author Experience: 2+ Years Location: Gurgaon (5 days Work from Office) Joining: Immediate joiners preferred Key Responsibilities: Create, edit, and manage digital content using AEM Manage digital assets (images, videos, etc.) within the AEM platform Work closely with cross-functional teams including designers, developers, and marketing Ensure content adheres to SEO, UX, and accessibility standards Utilize AEM templates and workflows for consistent and scalable content delivery Required Skills: Strong hands-on experience in AEM authoring Basic knowledge of HTML/CSS Excellent communication and attention to detail Understanding of SEO and content strategies Good to Have: AEM certifications Familiarity with AEM workflows and tools like Jira

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2 - 4 years

10 - 14 Lacs

Noida, New Delhi, Gurugram

Work from Office

Role: AEM Content Author Key Responsibilities: Create, edit, and manage digital content using AEM Manage digital assets (images, videos, etc.) within the AEM platform Work closely with cross-functional teams including designers, developers, and marketing Ensure content adheres to SEO, UX, and accessibility standards Utilize AEM templates and workflows for consistent and scalable content delivery Required Skills: Strong hands-on experience in AEM authoring Basic knowledge of HTML/CSS Authoring resource required to help Web and mobile teams implement content changes. Excellent communication and attention to detail Understanding of SEO and content strategies Good to Have: AEM certifications Familiarity with AEM workflows and tools like Jira Kindly share suitable profiles that match the above criteria at the earliest. Role & responsibilities

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8 - 12 years

0 - 3 Lacs

Pune, Bengaluru

Work from Office

Must have Technical authoring experience in diagnostics Automotive systems knowledge on ICE and Electric vehicles Knowledge of automotive engineering schematics and wiring diagrams XML editing (e.g., Adobe FrameMaker, ArborText Editor, Xmetal editor, etc.) Working knowledge on CMS,PC Skills (MS office suite) Knowledge of SharePoint usage Nice to have Technician experience,Diagnostic tool experience Proposal writing ,Knowledge on Repair information, Parts Catalogue and Labor Times Essentials Role Description Lead a team of Technical Authors to deliver high-quality guided diagnostics content on time and provide technical guidance and support to the team as needed. Develop, author, and update diagnostic procedures for various automotive systems, including ICE and Electric vehicles, using knowledge of wiring schematics, PIN out information, FMEAs, ODX, PID, DID, parts lists, and specifications. Collaborate with cross-functional teams to solve complex problems in content authoring, diagnostic authoring tools, and guided diagnostic tools, and consult with internal and external SMEs to obtain requirements. Estimate efforts for upcoming projects, draft technical proposals, and assist project managers with project planning, ensuring projects are delivered on time, within budget, and with accuracy. Provide demonstrations of authoring and diagnostic tools to customers, and convert POCs into successful production projects. Analyze existing and potential content to identify opportunities for reuse and optimization, focusing on data repositories and fault tree sequences. Manage workload, achieve results with minimal supervision, and advise project managers on project status and potential issues.

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10 - 15 years

15 - 25 Lacs

Noida

Remote

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

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5.0 - 10.0 years

5 - 15 Lacs

hyderabad, chennai, bengaluru

Hybrid

Roles and Responsibilities Design, develop, and execute comprehensive test plans for Adobe Experience Manager (AEM) applications using Selenium WebDriver. Collaborate with cross-functional teams to identify defects and provide detailed bug reports in JIRA. Develop automation frameworks for regression testing of AEM components using Authoring tools like Framemaker, InDesign, etc. Participate in Agile development cycles by providing input on project requirements and contributing to sprint planning sessions. Troubleshoot issues related to AEM application performance optimization and scalability. Desired Candidate Profile 5-10 years of experience in Aem Testing with expertise in Adobe Experience Management (AEM). Bachelor's degree in B.Tech/B.E. from a recognized university. Strong understanding of software development life cycle (SDLC) methodologies such as Agile/Scrum. Proficiency in programming languages like Java or JavaScript; knowledge of HTML5/CSS3/XML/JSON is an added advantage.

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2.0 - 5.0 years

3 - 6 Lacs

pune

Work from Office

Key Responsibilities: Documentation Development & Management Develop and edit technical documents including manuals, user guides, installation/work instructions, and help files. Generate and export source files from various formats (e.g., Techpub Studio, XML, Photoshop, PDF Xchange, PDF Editor, Rapid Illustrator). Configure and execute publishing workflows. Localization & Translation Support Prepare source files for translation and create translation projects using TMS platforms. Integrate translated content into documentation using tools like Aegisub, Photoshop, Illustrator, and Office. Validate syntax and formatting in localized files and debug publishing errors. Required Skills & Tools: Instructional Design, Documentation, S1000D Specification, STE, DDLC Content Management System Experience with Authoring Tools (Tech Pub Studio, XML), Illustration Software (Photoshop, Rapid Manual/2D Editor), CMS software (JIRA, SAP) Excellent written and verbal communication. Qualifications: Bachelor’s degree in Engineering, Technical Writing, Communications, or a related field. 4+ years of experience in technical publications

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4.0 - 7.0 years

10 - 20 Lacs

noida, new delhi, delhi / ncr

Hybrid

Role: AEM Tester (2 roles) Location: Greater Noida Experience: 4 to 7 years Shift Timings: 10:30 to 7:30 PM IST Notice Period: Immediate to 30 days Key Responsibilities: Develop and execute test plans, test cases, and test scripts based on AEM project requirements Perform functional, regression, integration, system, and performance testing on AEM components, templates, workflows, and APIs. Identify, log, and track defects using tools like JIRA or similar. Collaborate with cross-functional teams to ensure quality standards are met throughout the development life cycle. Participate in Agile ceremonies, sprint planning, and backlog grooming from a QA perspective. Monitor application performance and stability, reporting issues for resolution. Contribute to test automation efforts using tools such as Selenium, JUnit, TestNG, and Cucumber (BDD) Required Skills & Qualifications: 46 years of QA experience, with 2+ years in AEM testing. Strong understanding of AEM architecture, including components, templates, workflows, and CRX repository. Experience with automated testing frameworks and scripting languages. Familiarity with REST API testing tools like Postman or SoapUI. Excellent analytical, problem-solving, and communication skills. Bachelor’s degree in Computer Science, IT, or related field.

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9.0 - 12.0 years

6 - 10 Lacs

pune

Work from Office

Responsibilities: Ensures Knowledge transfer and documentation from existing MDM/Parts books team members as we transition functions to COE in India. Works closely with the NPI team on AMPIP project timing to help support the Parts book scheduling calendar Works closely with the Regional/site engineering and product management teams on project expectation clarifications as questions arise Works closely with the Regional/site MDM teams to ensure that the service Level Definition (SLD) is clearly defined Help ensure the quality of the work completed by the functional teams Works closely with the Product Support Team on understanding of the field support/production cut in on the PSP needs. To ensure the parts catalogs are updated to reflect future timing on PSP changes. Works with the efforts of MDM, Parts Books, e-commerce and Tech Info teams on aligning efforts in terminologies and translations on data delivery to our viewing systems to continue with meeting the needs of Farmer First. Skills: Experience:9–12 years of relevant experience in Parts Catalog Authoring Global Exposure: Prior experience working with global teams Communication: Fluent in English (spoken and written) Collaboration: Willingness to coordinate and attend meetings with teams in Germany and Italy, which may require working during Central European Time (CET) hours on some occasions. Good project management skills

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6.0 - 11.0 years

15 - 30 Lacs

chennai

Work from Office

Role & responsibilities Key Responsibilities : • Should have hands-on Techno-functional Configurations skills of Kinaxis RapidResponse • Should have strong Configuration, Authoring of resources in Kinaxis RapidResponse for different modules. • Work with cross-functional teams to drive successful deployments on Demand planning, S&OP, Supply Planning, Production planning & Scheduling etc across various business lines • Be a part of an Agile project team utilizing the Agile / Scrum methodologies, working in a fast-paced, iterative environment, closely partnering with business stakeholders. • Create functional design documentation, software specifications, testing/training scenarios and evaluate business processes for improvement opportunities • Provide expert functional and process guidance on system capabilities and solution approaches. • Configure Kinaxis Rapid Response and customize solutions as per clients requirements Key Skills: • Functional: Expertise and In-depth knowledge of supply chain planning in the areas of Supply and Capacity Planning, Production Planning, Material requirements planning, Long term capacity planning, rough cut capacity planning, resource planning, capacity constraints and scheduling. • Analytical: Ability to analyze supply chain operational data, to identify opportunities and develop insights. Perform fit-gap analysis. • Technical: Workbook development Table based, composite, data modification, Alerts – Monitoring, Hierarchies and Filters, Scenario hierarchy setup to meet process needs, Perspective development for Scenarios, Control Table Configuration, Planning Engine Knowledge, Data Model modification including custom fields and custom tables. Configuring solutions in Rapid Response and creating workbooks & reports. • Good knowledge of MS Excel and preparing PowerPoint presentations • Strong business acumen and execution experience in supply chain process and systems • Very good collaboration skills and ability to interact with multi-cultural teams spread across geographies. Key Experience and Education Requirements: • 4+ years of experience in in Kinaxis Rapid Response or similar solution implementations • Prior Solution developer experience of 1-2 projects on Kinaxis Rapid Response platform across industry verticals. • Experience in FMCG/CPG/Retail/Manufacturing industry. Multinational exposure is preferred • Bachelor’s Degree in Engineering (Tier-1 Engineering Colleges preferred) • MBA Operations/Supply Chain/Logistics /Engineering (preferred) • Kinaxis certifications will be an added advantage • Any relevant supply chain specific certifications like APICS (desirable)

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2.0 - 7.0 years

0 - 0 Lacs

mumbai suburban, navi mumbai, mumbai (all areas)

Work from Office

Role & responsibilities Demonstrated expertise in full-cycle content management, from creation to live deployment. Managed multimedia assets within the AEM Digital Asset Management (DAM) system with proficiency. Performed data transformation and validation to ensure accurate, consistent, and properly formatted content. Collaborated with stakeholders to ensure a smooth migration process, and provided training on AEM's content management capabilities. Collaborated with cross-functional teams to deliver visually appealing and user centric websites, leveraging proficiency in: HTML,CSS. Executed rigorous testing of AEM components and templates, upholding superior quality standards. Utilized workflow management tools, including Workfront, Jira, and SharePoint, for task efficiency. Employed AEM's quick publish and Manage Publication features for prompt content updates. Developed Translation Management Systems (TMS) to streamline multilingual content delivery. Oversaw Web Content Management System processes, ensuring timely content review and expiration. Collaborated with Marketing to create web pages that synchronized with campaign timelines. Strategically scheduled content releases in line with editorial calendars to bolster marketing efforts. Demonstrated expertise in Multi-Site Management, including: Language copies, Rollouts, Blueprints, Live copies Created Content Fragments and Experience Fragments to enhance personalized user engagement. Preferred candidate profile

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1.0 - 6.0 years

4 - 5 Lacs

coimbatore

Work from Office

SUMMARY Preparing spare parts catalogue with exploded views with BOM for our products Preparing operator manuals for our products (content writing also) Updating spare parts catalogue for ERN & PIN Designing of decals, safety stickers, display icons, etc Service checklist Service posters Restructuring existing spare parts catalogue Attending in ERN review meetings Also lend support to other teams based on requirement like PDE sticker, decal, LCD icons, symbols, etc. development work.

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9.0 - 14.0 years

20 - 30 Lacs

hyderabad, bengaluru, mumbai (all areas)

Hybrid

Role & responsibilities We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent thats bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com If this excites you, then apply below. Associate Manager – Regulatory Writing (Clinical) EXPERIENCE: 10 to 12 years’ experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) ROLE PURPOSE: This role is responsible for handling complex Medical Writing projects and provide review support for medical writing deliverables that support the clinical regulatory writing portfolio along with training the junior writers. SKILLS: • Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, ICFs & amendments, and Investigator Brochures (IBs) • Demonstrated excellence in focused/lean writing and editing following defined processes and templates • Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions • Understanding of clinical development process from program panning to submission, including clinical trial design • Communication skills commensurate with a professional working environment • Effective time management, organizational, and interpersonal skills • People management experience for more than 2 years • Customer focus • Comfortable following directions, templates, and structured processes for delivering documents for review and finalization • Able to work independently while maintaining communication with the Sponsor’s MW project manager • Ability to move across Therapeutic Areas to support business continuity and resource needs • Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines • Develop work plan and ensure adherence • Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion • Adherence to processes and Sponsor-defined best practices • Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements KNOWLEDGE REQUIREMENT: Scientific Knowledge • Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States • Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) • Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science • Understanding of medical practices regarding procedures, medications, and treatment for different disease states • Manage messaging for consistency with historical information and in alignment with agreed-upon strategy • Capable of providing insight, alternatives, and suggestions based on previous experiences • Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring • Experience writing protocols, amendments, CSR, and CTD summary documents Technology Skills • Expert authoring in MS Word, understanding of MS Word functionality • Experience working in document management systems; managing workflows eApproval/signatures • Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc. • Flexibility in adapting to new tools and technology • Capable of training writers/authors on the use of templates, guidelines, and tools RESPONSIBILITIES: • Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission documents (Module 2 summaries), and other regulatory documents on investigational drugs in various stages of clinical development • Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process • Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines • Develop and maintain project plans & work plan for the team members • People management • Work as an active member of cross-functional teams representing Medical Writing • Coordinate and deliver document kick-off meetings with writers and cross-functional representatives • Ensure adherence to standard content, lean authoring, and messaging across team members • Ensure communication between members remain open and information is disseminated appropriately • Possible participation in the orientation and coaching of junior team members • Conduct appropriate literature searches and screening, as needed • Participate on Medical Writing department initiatives, as appropriate. • Research regulatory requirements to remain current in the regulatory landscape • Share lessons learned and best practices • Ensure compliance with company training and time reporting EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

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