Role and Responsibilities:As a Sr. Dot Net Developer at DDi, you will be responsible for:Development of Microsoft .NET 4.x applications using CUtilizing core Microsoft .Net technologies including WCF and EFWorking with web development technologies such as ASP.NET, MVC3, JavaScript, AJAX, and CSSExperience in Oracle or SQL server or bothKnowledge on Mongo DB is an added advantageDebugging, performance profiling, and optimizationUnderstanding and applying object oriented and service oriented application development techniquesWorking both independently and in a team environmentExcellent oral, presentation, and written communication skillsCandidate Qualifications:To be eligible for this position, you should have:Education in BE/B. Tech/MCA/M Tech5-8 years of experience in the IT industryRequired Skills:Proficient in Microsoft .NET 4.x development using CGood knowledge and experience with core Microsoft .Net technologies including WCF and EFExperience with web development technologies including ASP.NET, MVC3, JavaScript, AJAX, and CSS.Angular /Angular Js is preferred

Job Title: Senior Regulatory Publishing SpecialistResponsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards.Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks.Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR.Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines.Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects.Qualifications:Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field.Experience: Minimum 3-6 years of hands-on experience within the CRO/Biotech/Biopharma industry.Expertise: Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation.Communication Skills: Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels.

Trained Business Analyst (Freshers)In-Office Hyderabad, Telangana, India Trained Business Analyst (Freshers)Hyderabad Company Overview:DDi, a MakroGroup of Company, is an innovative technology partner for BioPharma and Medical Device companies. With a unique blend of functional domain expertise, DDi serves the technology needs of the Clinical, Regulatory, and Enterprise domains. We provide innovative technology products and automation solutions for companies of various sizes.Role and Responsibilities:The Business Analyst will support senior BAs in eliciting and documenting requirements such as PRD, URS, FRS, RTM, and Impact Analysis. They will also assist the development team in clarifying functional requirements and perform functional testing to ensure the proper implementation of requirements. Regular updates and status reporting will be required.Candidate Qualifications:Education in BE/B Tec/M Tech - with a Computer Science/Studies background.Experience: 0 (Fresher)Required Skills:Good interpersonal and communication skillsStrong planning and critical thinking abilitiesSelf-directed and able to manage time and workload efficientlyInnovative mindset with a willingness to learn and implement new practices

Educational Qualification with Specialization: Engineering Graduate or Post Graduate Preferred background in Life SciencesTop Primary Skills Required for this Role: 2+ years experience in a QA Lead or Test Lead role, or 4+ years experience as a Sr. QAE Proficient in testing methodologies Hands-on experience with test management and bug tracking tools Capable of test planning and execution Ability to prepare comprehensive status reportsSecondary Skills Required for this Role: Strong verbal and written communication skills Attention to detail with superior problem-solving abilities Excellent organizational and time management skills Knowledge of SDLC Familiarity with 21 CFR Part 11 is an added advantageTertiary Skills Required for this Role: Capacity to operate in a flexible, dynamic environment requiring creative and strategic thinking Ability to work with demanding users in a high-pressure environment Essential multi-tasking abilitiesJob Description: Understand project scope, goals, and deliverables in collaboration with senior management and stakeholders Communicate project expectations to team members and stakeholders effectively and timely Develop test plans, mitigate risks to system quality, and obtain stakeholder support Identify training requirements and forward them to the Project Manager Estimate and secure management support for the necessary time, resources, and budget for testing Assign tasks to testing team members and ensure sufficient workload distribution Maintain the content and structure of all testing documents/artifacts Implement, monitor, and enforce testing processes as per organizational standards Review test case documents and resolve project team conflicts Manage project expectations, dependencies, and critical paths Track project milestones, deliverables, and prepare reports on testing activities Monitor new or changing project requirements Escalate project requirement issues to the Project Manager/Management Organize status meetings and send reports to stakeholders

Educational Qualification with Specialization: Engineering Graduate or Post Graduate Preferred background in Life SciencesTop Primary Skills Required for this Role: 2+ years experience in a QA Lead or Test Lead role, or 4+ years experience as a Sr. QAE Proficient in testing methodologies Hands-on experience with test management and bug tracking tools Capable of test planning and execution Ability to prepare comprehensive status reportsSecondary Skills Required for this Role: Strong verbal and written communication skills Attention to detail with superior problem-solving abilities Excellent organizational and time management skills Knowledge of SDLC Familiarity with 21 CFR Part 11 is an added advantageTertiary Skills Required for this Role: Capacity to operate in a flexible, dynamic environment requiring creative and strategic thinking Ability to work with demanding users in a high-pressure environment Essential multi-tasking abilitiesJob Description: Understand project scope, goals, and deliverables in collaboration with senior management and stakeholders Communicate project expectations to team members and stakeholders effectively and timely Develop test plans, mitigate risks to system quality, and obtain stakeholder support Identify training requirements and forward them to the Project Manager Estimate and secure management support for the necessary time, resources, and budget for testing Assign tasks to testing team members and ensure sufficient workload distribution Maintain the content and structure of all testing documents/artifacts Implement, monitor, and enforce testing processes as per organizational standards Review test case documents and resolve project team conflicts Manage project expectations, dependencies, and critical paths Track project milestones, deliverables, and prepare reports on testing activities Monitor new or changing project requirements Escalate project requirement issues to the Project Manager/Management Organize status meetings and send reports to stakeholdersLocation - Madhapur, Hyderabad, TS, India

Sr.Dot Net Developer(Full stack Dot Net developer)In-Office Hyderabad, Telangana, India Sr. Dot Net Developer (Sr .Full Stack Dot Net developer)Hyderabad, India DDi, a MakroGroup company https:www.ddismart.com, is an innovative Technology partner for BioPharma and Medical Device companies. With a unique blend of functional and domain expertise, DDi serves the technology needs of the Clinical, Regulatory, and Enterprise domains in the industry. DDi provides innovative technology products and automation solutions to companies of various sizes.Role and Responsibilities:As a Sr. Dot Net Developer at DDi, you will be responsible for:Development of Microsoft .NET 4.x applications using CUtilizing core Microsoft .Net technologies including WCF and EFWorking with web development technologies such as ASP.NET, MVC3, JavaScript, AJAX, and CSSExperience in Oracle or SQL server or bothKnowledge on Mongo DB is an added advantageDebugging, performance profiling, and optimizationUnderstanding and applying object oriented and service oriented application development techniquesWorking both independently and in a team environmentExcellent oral, presentation, and written communication skillsCandidate Qualifications:To be eligible for this position, you should have:Education in BE/B. Tech/MCA/M Tech5-8 years of experience in the IT industryRequired Skills:Proficient in Microsoft .NET 4.x development using CGood knowledge and experience with core Microsoft .Net technologies including WCF and EFExperience with web development technologies including ASP.NET, MVC3, JavaScript, AJAX, and CSS.Angular /Angular Js is preferred

Minimum Requirements7+ year experience as a Sr.UI developerCollege or University degree in Computer Science or a related discipline B Tech/MCACore Competency RequirementsExcellent communication and teamwork skillsWrite create clean, effective and unit testable code for simple or complex user tasksWork in different SDLC environments like waterfall, agile, rapid development and prototyping environment where effective communication is paramountContribute to building a positive, can-do, high-performance cultureAbility to work with cross functional technology teams, product management teams and UX teams to drive exceptional user experienceMaintain/support existing web/mobile applicationsSkills: Angular, Bootstrap.Looking mainly into Front End DeveloperJob Requirement:Excellent Proficiency with JavaScript, CSS3, HTML5, RESTful APIsStrong proficiency with web related protocols and architectures (MVC, MVVM, REST APIs, JSON, HTTP)Experience in working with angular, bootstrap and data visualization libraries Validating user actions on the client side and providing responsive feedback Experience with responsive web design and development, cross browser compatibility and high performingDeep knowledge of Angular or AngularJS practices and commonly used modules based on extensive work experience. Creating custom, general use modules and components which extend the elements and modules of core Angular or AngularJS, when needed. Excellent understanding of OOP patterns and methodologies and experience with OO languagesExperience with solving UI App memory and performance issuesAttention to UI and UX detailsThorough understanding of the responsibilities of the platform, database, API and other web services used in the system.

Sr.UI DeveloperMinimum Requirements7+ year experience as a Sr.UI developerCollege or University degree in Computer Science or a related discipline B Tech/MCACore Competency RequirementsExcellent communication and teamwork skillsWrite create clean, effective and unit testable code for simple or complex user tasksWork in different SDLC environments like waterfall, agile, rapid development and prototyping environment where effective communication is paramountContribute to building a positive, can-do, high-performance cultureAbility to work with cross functional technology teams, product management teams and UX teams to drive exceptional user experienceMaintain/support existing web/mobile applicationsSkills: Angular, Bootstrap.Looking mainly into Front End DeveloperJob Requirement:Excellent Proficiency with JavaScript, CSS3, HTML5, RESTful APIsStrong proficiency with web related protocols and architectures (MVC, MVVM, REST APIs, JSON, HTTP)Experience in working with angular, bootstrap and data visualization libraries Validating user actions on the client side and providing responsive feedback Experience with responsive web design and development, cross browser compatibility and high performingDeep knowledge of Angular or AngularJS practices and commonly used modules based on extensive work experience. Creating custom, general use modules and components which extend the elements and modules of core Angular or AngularJS, when needed. Excellent understanding of OOP patterns and methodologies and experience with OO languagesExperience with solving UI App memory and performance issuesAttention to UI and UX detailsThorough understanding of the responsibilities of the platform, database, API and other web services used in the system.

Key Responsibilities:Lead and manage the end-to-end delivery of IT/software projects, ensuring projects are completed within scope, on time, and within budget.Collaborate with stakeholders to define project scope, objectives, and deliverables that align with business goals.Develop and manage project plans, including schedules, resource allocation, and risk management strategies.Guide cross-functional teams, offering direction and support to meet project milestones and ensure successful outcomes.Identify and mitigate project risks, proactively addressing potential issues before they escalate.Track and report on project performance, providing detailed progress updates to stakeholders and leadership.Implement and enforce Agile methodologies to streamline project workflows and enhance team collaboration.Partner with technical teams to ensure all project requirements and goals are fully understood and met.Manage stakeholder expectations, ensuring clear, consistent communication throughout the project lifecycle.Facilitate decision-making processes and resolve conflicts to keep projects on track and aligned with business goals.Ensure adherence to industry best practices and quality standards in all phases of software development.Lead continuous improvement initiatives to enhance project management processes and delivery efficiency.Conduct post-project reviews, identifying lessons learned and areas for future improvement.Required Qualifications:Bachelor's or Masters degree in Computer Science, Engineering, or a related field.8+ years of experience in IT/Technical Project Management, specifically within the software/IT product development space.Proven ability to manage and deliver complex IT/software projects from initiation through delivery.Expertise in project management methodologies such as Agile, Waterfall, or Hybrid models.Proficiency in Agile frameworks and practices, with a focus on continuous improvement.Strong leadership capabilities, with experience in managing cross-functional teams in a fast-paced environment.In-depth understanding of the software development lifecycle (SDLC) and technical concepts.Exceptional communication skills, with the ability to manage stakeholders at all levels.Analytical mindset with the ability to solve complex problems and make informed decisions.Demonstrated experience in risk management and implementing mitigation strategies.Proven track record of delivering high-quality software products on time and within budget.Project Management Certification (e.g., PMP, PRINCE2) is preferred but not required.Ability to thrive in a dynamic work environment with shifting priorities and demands.Strong conflict resolution and decision-making skills to keep projects on track.Proficiency in project management and collaboration tools such as Jira, Trello, or MS Project.Continuous learner with a commitment to staying updated on industry trends and advancements.

Project CoordinatorHelp PM/ Designee to Define and Manage scope by coordinating for development and approval of the requirements documents PRD, URS & FRS. In an independent role, work with Business Analyst for these documents to monitor & report the progress.Assist the PM/ Designee in drafting schedules and other project related documents. In an independent role, develop and maintain detailed project scheduleAssist the PM/ Designeein developing and managing communications plan. In an independent role, develop and manage communication planMonitor & manage project deliverables in line with the project plan and report to managementHelp PM/ Designeeto develop and maintain project "RAID" logs (Risks, Actions, Issues, Decision)Help PM/ Designeeto manage project scope, change control and escalate issues where necessary. In an independent role, manage the same with help Business Analyst whenever requiredUse project scheduling and control tools to monitor & report project progress and performanceHelp PM/ Designeeto work closely with users to ensure that project meets business needs. In an independent role, work with Business Analyst for the sameDefine and manage the User Acceptance Criteria with help of Business AnalystProvide regular status reports to PM and/or managementDistribute minutes to all project team membersEffectively and accurately communicate relevant project information to the project team as directed by PM/ ManagementHelp PM/ Designeeto ensure pre go-live communications are prepared, reviewed and distributedCoordinate go-live readiness activities as directed by PM/ ManagementCoordinate closure activities as directed by PM/ ManagementPerforms all other related duties as assigned

Role : IT Project ManagerKey Responsibilities:Lead and manage the end-to-end delivery of IT/software projects, ensuring projects are completed within scope, on time, and within budget.Collaborate with stakeholders to define project scope, objectives, and deliverables that align with business goals.Develop and manage project plans, including schedules, resource allocation, and risk management strategies.Guide cross-functional teams, offering direction and support to meet project milestones and ensure successful outcomes.Identify and mitigate project risks, proactively addressing potential issues before they escalate.Track and report on project performance, providing detailed progress updates to stakeholders and leadership.Implement and enforce Agile methodologies to streamline project workflows and enhance team collaboration.Partner with technical teams to ensure all project requirements and goals are fully understood and met.Manage stakeholder expectations, ensuring clear, consistent communication throughout the project lifecycle.Facilitate decision-making processes and resolve conflicts to keep projects on track and aligned with business goals.Ensure adherence to industry best practices and quality standards in all phases of software development.Lead continuous improvement initiatives to enhance project management processes and delivery efficiency.Conduct post-project reviews, identifying lessons learned and areas for future improvement.Required Qualifications:Bachelor's or Masters degree in Computer Science, Engineering, or a related field.8+ years of experience in IT/Technical Project Management, specifically within the software/IT product development space.Proven ability to manage and deliver complex IT/software projects from initiation through delivery.Expertise in project management methodologies such as Agile, Waterfall, or Hybrid models.Proficiency in Agile frameworks and practices, with a focus on continuous improvement.Strong leadership capabilities, with experience in managing cross-functional teams in a fast-paced environment.In-depth understanding of the software development lifecycle (SDLC) and technical concepts.Exceptional communication skills, with the ability to manage stakeholders at all levels.Analytical mindset with the ability to solve complex problems and make informed decisions.Demonstrated experience in risk management and implementing mitigation strategies.Proven track record of delivering high-quality software products on time and within budget.Project Management Certification (e.g., PMP, PRINCE2) is preferred but not required.Ability to thrive in a dynamic work environment with shifting priorities and demands.Strong conflict resolution and decision-making skills to keep projects on track.Proficiency in project management and collaboration tools such as Jira, Trello, or MS Project.Continuous learner with a commitment to staying updated on industry trends and advancements.Skills : - Software,Project Management,Stakeholder,Agile,Jira,Waterfall,stakeholder analysis,MS,Project,Software Development

Help PM/ Designee to Define and Manage scope by coordinating for development and approval of the requirements documents PRD, URS & FRS. In an independent role, work with Business Analyst for these documents to monitor & report the progress.Assist the PM/ Designee in drafting schedules and other project related documents. In an independent role, develop and maintain detailed project scheduleAssist the PM/ Designee in developing and managing communications plan. In an independent role, develop and manage communication planMonitor & manage project deliverables in line with the project plan and report to managementHelp PM/ Designeeto develop and maintain project "RAID" logs (Risks, Actions, Issues, Decision)Help PM/ Designeeto manage project scope, change control and escalate issues where necessary. In an independent role, manage the same with help Business Analyst whenever requiredUse project scheduling and control tools to monitor & report project progress and performanceHelp PM/ Designeeto work closely with users to ensure that project meets business needs. In an independent role, work with Business Analyst for the sameDefine and manage the User Acceptance Criteria with help of Business AnalystProvide regular status reports to PM and/or managementDistribute minutes to all project team membersEffectively and accurately communicate relevant project information to the project team as directed by PM/ ManagementHelp PM/ Designeeto ensure pre go-live communications are prepared, reviewed and distributedCoordinate go-live readiness activities as directed by PM/ ManagementCoordinate closure activities as directed by PM/ ManagementPerforms all other related duties as assigned.