46 Rim Jobs - Page 2

Advisor, Records and Information Management (RIM) Purpose and Scope: Under the direction of the Lead of Global RIM, responsible for planning, developing, and administrating the Records and Information Management (RIM) program for our company. Provides consistent RIM guidance and leads RIM initiatives to ensure compliance with relevant regulatory, legal, and business requirements. Independently coordinates the resources necessary for successful execution of RIM projects, meets business objectives and ensures outstanding customer service. Job responsibilities cover various facets of the comprehensive Global RIM program across the company, including affiliates and sites. Responsibilities and Accountabilities: Implements and maintains a comprehensive RIM program framework, including policies, procedures and the Record Retention Schedule that reflects current global pharmaceutical regulatory, legal, and business requirements. Identifies and leads RIM initiatives, monitors, and reports on progress in achieving program milestones. Provide leadership within the enterprise as the subject matter expert on Records and Information Management methodologies and practices from a global perspective. Leads design and implementation of change management efforts with respect to adherence to RIM policies and procedures, etc. Partners with Litigation and other legal members on RIM-related and/or discovery issues and training for Legal Hold Order/information lifecycle management. Manage and oversee RIM team and service providers including, off-site storage vendors and RIM consultants. Develops RIM procedures, guidelines, communications, and training for the Global RIM program. Monitors program compliance and proactively addresses concerns and deviations; provides guidance; conducts department-level audits to ensure compliance with RIM policy, SOPs, and retention schedule; reports findings and recommends solutions to RIM Lead; coordinates any corrective actions necessary. Collaborates with IT to align corporate systems and to design and configure RIM tools to implementation of RIM practices in business processes; establishes standards for metadata capture and records Job responsibilities cover various facets of the comprehensive Global RIM program across the company, including affiliates and sites. Implements and maintains a comprehensive RIM program framework, including policies, procedures and the Record Retention Schedule that reflects current global pharmaceutical regulatory, legal, and business requirements. Identifies and leads RIM initiatives, monitors, and reports on progress in achieving program milestones. Provide leadership within the enterprise as the subject matter expert on Records and Information Management methodologies and practices from a global perspective. Leads design and implementation of change management efforts with respect to adherence to RIM policies and procedures, etc. Partners with Litigation and other legal members on RIM-related and/or discovery issues and training for Legal Hold Order/information lifecycle management. Manage and oversee RIM team and service providers including, off-site storage vendors and RIM consultants. Develops RIM procedures, guidelines, communications, and training for the Global RIM program. Monitors program compliance and proactively address concerns and deviations; provides guidance; conducts department-level audits to ensure compliance with RIM policy, SOPs, and retention schedule; reports findings and recommends solutions to RIM Lead; coordinates any corrective actions necessary. Collaborates with IT to align corporate systems and to design and configure RIM tools to implementation of RIM practices in business processes; establishes standards for metadata capture and records classification. Assists in support activities needed for RIM technology tools, such as migration, legacy data cleansing, system testing and validation activities. Assesses new business needs for on-boarding into RIM technology tools, including review and approval of requirements for new user groups, requests for access, needs for workflows based on business process and levels of user training. Designs and implements training tools for employees and contractors on how to manage information using technology tools. Oversees management of the Global RIM SharePoint Intranet pages to make sure it provides appropriate RIM resources, training, and information to all our employees. Provides subject matter expertise for the companys Records Management Solution (RMS) powered by OpenText Content Manager across the enterprise. Manages the network of Business Liaisons, Site Liaisons and Records Coordinators to coordinate implementation, share best practices and support compliance with RIM policies and practices. Develops annual communication plan to key stakeholders and what themes on which to focus, the media which will be used and on what schedule. Resolves RIM issues by evaluating and identifying business process improvements that will facilitate more efficient RIM and compliance with RIM governance. Bachelors Degree, preferably in Business, Library/Information Science or related field, or related experience and/or training. 6+ years experience with RIM practices and procedures, in the pharmaceutical industry preferred. Strong project management skills. Experienced in conducting business process interviews with respect to Records and Information management. Demonstrated interpersonal and negotiating skills. Ability to work independently and collaboratively with all levels of associates and management. Strong knowledge of systems, databases and electronic records management functionality in document management and collaborative systems (shared drives, M365 SharePoint, Veeva Vault, OpenText Content Manager. Excellent verbal and written communication and listening skills. Requirements Preferred Qualifications: 7+ years experience with RIM practices and procedures, in the pharmaceutical industry preferred. Demonstrated experience working collaboratively to analyze processes and identify process improvements. Advanced degree in business, management, information management or project management Industry related designation and /or certifications: hold one or more, recognized Records and Information Management training certifications and accreditations such as ICRM, AIIM ERM and ECM Specialist / Practitioner, AIIM Certified Information Professional (CIP), ARMA Information Governance Professional (IGP). Working Environment: At our company we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with companys responsible flexibility guidelines.

Job Description Analyst, Records and Information Management (RIM) Purpose and Scope: Under the direction of the Lead of Global RIM, responsible for planning, developing, and administrating the Records and Information Management (RIM) program for our company. Provides consistent RIM guidance and leads RIM initiatives to ensure compliance with relevant regulatory, legal, and business requirements. Independently coordinates the resources necessary for successful execution of RIM projects, meets business objectives and ensures outstanding customer service. Responsibilities and Accountabilities: Job responsibilities cover various facets of the comprehensive Global RIM program across the company, including affiliates and sites. Assist in implementation and maintenance of a comprehensive RIM program framework, including policies, procedures and the Record Retention Schedule that reflects current global pharmaceutical regulatory, legal, and business requirements. Assist on RIM initiatives, monitors, and reports on progress in achieving program milestones. Participate in design and implementation of change management efforts with respect to adherence to RIM policies and procedures, etc. Collaborate with Litigation and other legal members on RIM-related and/or discovery issues and training for Legal Hold Order/information lifecycle management. Participate in development of RIM procedures, guidelines, communications, and training for the Global RIM program. Collaborates with IT to align corporate systems and to design and configure RIM tools to implementation of RIM practices in business processes; establishes standards for metadata capture and records classification. Assist in support activities needed for RIM technology tools, such as migration, legacy data cleansing, system testing and validation activities. Maintain the Global RIM SharePoint Intranet pages to make sure it provides appropriate RIM resources, training, and information to all employees. Provides subject matter expertise for the companys Records Management Solution (RMS) powered by OpenText Content Manager across the enterprise. Assist in the management of network of Business Liaisons, Site Liaisons and Records Coordinators to coordinate implementation, share best practices, and support compliance with RIM policies and practices. Assist in development of annual communication plan to key stakeholders and what themes on which to focus, the media which will be used and on what schedule. Resolves RIM issues by evaluating and identifying business process improvements that will facilitate more efficient RIM and compliance with RIM governance. Requirements Required Qualifications: Bachelors Degree, preferably in Business, Library/Information Science or related field, or related experience and/or training. 3+ years’ experience with RIM practices and procedures, in the pharmaceutical industry preferred. Strong project management skills. Demonstrated interpersonal and negotiating skills. Ability to work independently and collaboratively with all levels of associates and management. Knowledge of systems, databases and electronic records management functionality in document management and collaborative systems (shared drives, M365 SharePoint, Veeva Vault, OpenText Content Manager. Excellent verbal and written communication and listening skills. Preferred Qualifications: 4+ years’ experience with RIM practices and procedures, in the pharmaceutical industry preferred. Demonstrated experience working collaboratively to analyze processes and identify process improvements. Advanced degree in business, management, or information management Working Environment: At our organization we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with our company’s’ Responsible Flexibility Guidelines.

Key Responsibilities: Participates in the estimation of activities, owns technical implementation of the SaaS application, and responsible for the design, configuration and integration for new and modified features for CTMS/eTMF and other Veeva Vaults. This role will have a keen focus to detail through ensuring Veeva applications is deployed using the framework of the Veeva Vault configuration standards and best practices. Works closely with business to understand the business requirements. Thinks critically to help them design the solution they actually need; not just the solution they think they need. Participates in the requirements workshops, design, prototype, configure and document Veeva solutions. Implements Veeva suite of application to meet the business, functional, security and integration requirements either via configuration or custom development using Veeva Vault SDK. Participates in the testing and validation activities by helping in the creation and review of test scenarios, data staging, test executions and validation documents. Works with the Veeva support teams to provide technical solutions to production issues/integration issues. Experience: Experience working with or for Life Sciences companies; including, Pharmaceutical, Biotechnology, Healthcare, or Medical Device organizations with knowledge of drug development processes and regulatory submissions Solid experience in configuration in Veeva Vault and a strong learning attitude towards other vaults in Veeva. Exposure in Veeva Vault Data Model - Understanding of Products, eTMF, Clinical Studies, Sites. System implementation experience as developer for Veeva application. Desirable experience working with Veeva Vault SDK to deliver custom solutions by extending the application capabilities. Fair understanding of Veeva Vault data model, data loader and migration tools and technologies Understand and implement Veeva integrations (Vault to Vault / Vault to other systems or middleware like MuleSoft) Understanding of health care regulations, international regulations, and privacy controls Basic Qualifications : Bachelors Degree (or equivalent work experience) 3+ years of experience in Veeva application configuration/development Strong teamwork, self-management, problem-solving abilities Excellent oral and written communication skills Trained and Certified in Veeva Vault

Research & Development Consultant – Life Sciences and Health Join our team in Strategy consulting to find endless opportunities and solve our clients toughest" challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Life Sciences & Health, Industry Consulting, Capability Network I Areas of Work: Research & Development (R&D) | Level: Consultant | Location: Delhi, Gurgaon, Mumbai, Bangalore Years of Exp: 3 -6 years Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your interest? Then, Accenture Strategy and Consulting is the right place for you to explore limitless possibilities. As a part of the Accenture Life Sciences practice , our 4000+ practitioners across the globe, help our clients make a meaningful impact on patients' lives through New Science, novel medical technologies and better collaboration. Together, let's deliver more effective, affordable, personalized patient outcomes. In this practice, you'll help drive our Life Sciences clients' strategy and business planning efforts, with the following initiatives: Support delivery of small to medium-size teams to deliver management consulting projects for global clients. Responsibilities may include strategy, implementation, process design and change management for specific modules Support efforts global sales team to identify and win potential opportunities within the practice. Provide industry expertise in various sub-segments of the LS industry Develop assets and methodologies , point-of-view, research or white papers for use by the team and larger community. Acquire skills that have utility across industry groups. Support on strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with client's business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Acquire skills that have utility across industry groups. Bring your best skills forward to excel in the role: Industry expertise with a global top pharmaceutical, medical devices or biotechnology firm Familiarity or expertise with assets or tools in business consulting such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on Good functional and domain knowledge with relevant experience in the same area Make presentations wherever required to a known audience or client on functional aspects of his or her domain Should have worked with multi-functional teams and cross-functional stakeholders Ability to solve complex business problems and deliver client delight Strong writing skills to build point of views on current industry trends Strong program management skills Good analytical and problem-solving skills with an aptitude to learn quickly Good communication , interpersonal and presentation skills Read more about us. Recent Blogs Qualifications Your experience counts! MBA from a Tier 1 institute or rich relevant industry experience 3 -6 years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences i ndustry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting ( R&D ), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, o perating m odel, b usiness p rocess mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite , pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable What’s in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything—from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions — underpinned by the world’s largest delivery network — Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients’ future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our Capability Network – a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our Capability Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. For more information visit https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team .

Let’s do this. Let’s change the world. In this vital role you will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing strategic technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management, regulatory affairs, and people management. Roles & Responsibilities: Manage various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers Serve as primary point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in the appropriate system Independently remain current on guidance (internal/external) and translate requirements into operational activities Effectively represent global submission management expertise on key projects and global workstreams Take part in the career and skills development of staff members Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Represent departmental expertise on global work streams Initiate, lead and manage process development and improvement Lead information system and software update projects as well as ongoing system validations from a publishing perspective Develop and report metrics to senior management Provide technical support for regulatory systems Manage relationships with contributing functions and affiliates 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: Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Strong working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Subject Matter Expert for the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications Expert knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Expert knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. 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

Overseeing the entire organizational operations, ensuring alignment of all departments towards company objectives, and driving business growth, profitability, and efficiency. Strategic planning, operational excellence, and compliance adherence. Required Candidate profile Work closely with department heads to optimize production, quality, supply chain, maintenance, and logistics to enhance overall company performance. Candidate from Bicycle industry preferred

The Senior Associate, Clinical Trial Submission Management, will help ensure the technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. This vital role is assigned to one or more Amgen products under development to ensure clinical trial application approvals in the EU, delivering technical compliance with EU Clinical Trial Regulation No.536/2014 for every clinical trial submission dossier through close internal cross-functional collaboration. Roles & Responsibilities: Support assembly of the submission package and supportive documentation for regulatory deliverables, for the management of clinical trials Be the operational driver for Clinical Trial Submissions and notifications in the state-of-the-art regulatory document management system and maintain tracking systems. Be the critical technical coordinator for Clinical Trial Submissions and notifications through the EMA CTIS system, performing accurate and timely input of data and documents into the EMA Clinical Trial Information System for Clinical Trial Applications, Modifications and Notifications. Be the Single Point of Contact for incoming EMA CTIS notifications and alerts through daily monitoring and swift dispatching of incoming requests to cross functional teams. Be responsible for reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teams. Ensure Requests for Information are tracked within the document management system. Recipient of notification of compliant events from Amgen Clinical Trial Registry System for input into CTIS within regulation timelines. Ensure efficient and timely data entry and communication of submissions to key process stakeholders. Submitting Clinical Trial Results to CTIS through the Marketing Authorisation Holder Access. Support Sponsor High Level Administrator within CTIS with access requests. Act as Subject Matter Expert for CTIS providing intelligence and expertise on technical submission requirements and system processes. Assist with definition, development, and implementation of processes to meet the evolving CTIS needs. Escalates, informs and resolves any issues that may impact submission process or timelines within CTIS. Build effective relationships and communication paths across local and functional organizations. Enable efficiencies and seamless execution across the EU region countries Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in teams Advanced knowledge of the regulations and regulatory guidance applicable to EU Clinical Trial Applications Advanced knowledge of the submission and maintenance of EU Clinical Trial Applications Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Proven experience of working with clinical trial applications under CTR Basic Education and Experience: Master’s degree and 1-2 years of directly related experience OR Bachelor’s degree and 2-3 years of directly related experience OR Associate’s degree and 3-5 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with CTIS system

Let’s do this. Let’s change the world. In this vital role you will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the International (non-Americas) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing strategic technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management, regulatory affairs, and people management. Roles & Responsibilities: Manage various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers Serve as primary point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in the appropriate system Independently remain current on guidance (internal/external) and translate requirements into operational activities Effectively represent global submission management expertise on key projects and global workstreams Take part in the career and skills development of staff members Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Represent departmental expertise on global work streams Initiate, lead and manage process development and improvement Lead information system and software update projects as well as ongoing system validations from a publishing perspective Develop and report metrics to senior management Provide technical support for regulatory systems Manage relationships with contributing functions and affiliates 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: Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Strong working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Subject Matter Expert for the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications Expert knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Expert knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. 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

The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for EU, JAPAC, GCC, ZA

The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information. As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and system use. You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving demands of the regulatory landscape. Your expertise will help shape the future of regulatory operations by streamlining processes and driving compliance across global markets. Roles & Responsibilities: Responsible for maintaining data within the Regulatory Information Management (RIM) system Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system Serve as a Data Management SME within cross-functional collaborative initiatives Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives Provide support on creating, running and analysing reports for data streamline projects Develop and deliver training materials and presentations to a global audience Manage the protocol Amendment New Investigator (PANI) submission updates Manage 1572 forms for FDA submission Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance In depth understanding of the Veeva Vault system Good written and verbal communication skills Detail oriented Independent time management and prioritization skills Work efficiently with little support and minimal to no supervision Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect Critical thinking skills Appropriate software skills as required Strong analytical and problem solving, communication and presentation skills Good understanding of business complexity and project inter-dependencies Be a great teammate who can work effectively at all levels of an organization with the ability to influence others to move toward consensus Fluent in English, both in oral and written communication Experience in supporting projects / improvement initiatives Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM Be open to working in a dynamic environment embracing change as a constant and adopting new technologies Working in global teams and matrix organizations Able to follow through on tasks and motivate others to meet deadlines Basic Education and Experience: Master’s degree and 1-2 years of directly related experience OR Bachelor’s degree and 2-3 years of directly related experience OR Associate’s degree and 3-5 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with CTIS system

QMS Consultant & Veeva Vault Project Support Analyst Role Overview We are seeking a professional with expertise in Quality Management Systems (QMS) and Veeva Vault to support the implementation, migration, and optimization of quality management processes. This role will focus on document and data migration, regulatory compliance, system integration, and ongoing support for Veeva Vault applications. The candidate will work from 5:30 PM IST 2:30 AM IST to align with the US time zone . Key Responsibilities Quality Management & Compliance Provide subject matter expertise on Vault R&D migration and quality management . Ensure quality standards, GxP compliance, and regulatory requirements (e.g., ISO 9001) are met. Conduct risk assessments to identify compliance gaps and inefficiencies. Define document classification and approval workflows aligned with industry best practices. Develop, implement, and maintain standard operating procedures (SOPs) and workflows for quality management. Manage change control processes , ensuring minimal disruption to quality standards. Implement post-migration quality checks to ensure document integrity. Provide ongoing monitoring and support for quality management tools and systems integrated with Veeva Vault. Track quality metrics, risks, and issues in compliance reports. Veeva Vault Implementation & Support Assist in migrating data and documents into Veeva Vault , ensuring accuracy and compliance. Collaborate with cross-functional teams to gather requirements and align migration activities with project goals. Provide technical expertise on Veeva Vault functionalities, workflows, integrations, and best practices . Conduct data quality checks post-migration to validate completeness and integrity. Troubleshoot technical issues and provide system support. Optimize automation, reporting, and regulatory compliance tracking within Veeva Vault. Communicate with both technical and non-technical teams to bridge business needs with system specifications. Identify, assess, and escalate potential risks related to migration and system integration. Training & Stakeholder Engagement Develop and update training documents and job aids for new Veeva Vault practices. Work alongside the Training & Procedures Team to provide comprehensive end-user training. Conduct product demonstrations and stakeholder engagement sessions to ensure seamless adoption. Gather and address stakeholder feedback to improve system functionalities and compliance adherence. Required Skills & Experience Technical & Functional Expertise 3+ years of experience in Veeva Suite, Veeva Vault, and Quality Management Systems (QMS) . Prior experience with Veeva migration support, data/document migration, and metadata mapping . Experience working with Veeva Vault Quality Suite , including workflows, document types, reports, dashboards, and notifications. Strong understanding of GxP, ISO 9001, and software validation regulations . Hands-on experience in testing, script execution, and system troubleshooting . Experience in configuring and resolving issues in multiple Veeva Vaults . Soft Skills & Qualifications Veeva Admin Certification is required . Bachelors degree in life sciences, computer science, or a related field . Strong analytical, problem-solving, and attention to detail skills. Excellent communication and interpersonal skills to work collaboratively across teams. Ability to influence stakeholders and manage change control processes effectively. Highly organized and detail-oriented with strong documentation skills. This role is ideal for candidates who can blend technical expertise with quality management practices while ensuring seamless regulatory compliance, data integrity, and system optimization within Veeva Vault.

We are thrilled to announce an exciting opportunity for an IMS Presales role with SHI Locuz . EXP:5+ Location: Hyderabad Experience in understanding ITIL, ITOM tools & fundamentals Experience in knowledge of ISMS Experience with 5+ years in IT services / RIMS, including pre-sales Experience in deep understanding of IT infrastructure and the challenges faced by enterprises and IT practitioners in managing their increasingly complex IT infrastructure and navigating dynamics within IT organizations Experience in deep understanding of current IT sourcing models Experience in Pre Sales/Solution Design and/or Service Delivery with IT Infrastructure Services Experience with at least 5+ years in professional services/alliances/solution engineering/consulting/technical sales with expertise in architecting and deploying solutions, and rolling out new technology and solution initiatives Experience in facilitating and conducting webinars and presentations to customers, including conceptual design and whiteboard sessions Experience in interacting effectively with senior business managers Experience in building solutions, and tailoring proposals or presentations for given scenarios Experience with strong customer engagement background and expertise Experience in playing the role of trusted advisor for customers or partners Experience with excellent articulateness & interpersonal skills Job Description: - Analyze IT Infrastructure Services requirements for customers and design appropriate cost-effective services Model - Solutions/Service Design dealing with all components of an IT Infrastructure, Transition & Transformation (Technology & Services) - Evaluate, recommend, architect and implement Services solutions to enhance the IT Infrastructure Services. - Build solution documents, effort estimates. - Participate and team up with sales, delivery to provide complete solutions to customers. - Responsible to build and propose transformational services to customers, identify triggers, Identify key IT Infrastructure issues which impact the business and make recommendations to customers. - Build and develop business case, provide relevant and sound business & technical advice to the customer and present the same to various stakeholders within the company. - Map competition and develop appropriate winning sales strategies, often in conjunction with Field Sales Team. - Assist the sales group with (RFX) requests for quotes, information, bids, proposals and statements of work. - Create, maintain and publish a set of written procedures and best practices for the delivery of pre and post sales services to customers. - Present technical briefings to executives. - Work with Business Development Managers and/or Account Executives and other individuals within the sales group to maximize revenue potential by equipping them with the relevant material (RFP/RFI/RFQ responses, Solutions, etc.) - Support customer acquisition, conversion and retention targets

Veeva Vault Administrator with experience in GxP IT systems, Veeva Vault (RIMS/QMS) admin, system integration, and data migration. Responsibilities include release management, impact assessments, requirement coordination, and validation activities

Entity :- Accenture Strategy & Consulting Team :- Global Network Data & AI Practice :- Life Sciences Title :- Ind&Func AI Decision Science Manager Job Location :- Delhi, Gurgaon, Mumbai, Bangalore About S&C - Global Network :- Accenture GN's Data & AI (AI Hub India) practice helps our clients grow their business in entirely new ways. Analytics enables our clients to achieve high performance through insights from data - insights that inform better decisions and strengthen customer relationships. From strategy to execution, Accenture works with organizations to develop analytic capabilities - from accessing and reporting on data to predictive modeling to outperform the competition. WHAT'S IN IT FOR YOU? An opportunity to work on high-visibility projects with top Pharma clients around the globe. Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything"from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Qualifications What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter expertise in various sub-segments of the LS industry. Develop assets and methodologies, point-of-view, research, or white papers for use by the team and the larger community. Acquire new skills that have utility across industry groups. Support strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for? Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills.

Entity :- Accenture Strategy & Consulting Team :- Global Network Data & AI Practice :- Life Sciences Title :- Ind&Func AI Decision Science Manager Job Location :- Delhi, Gurgaon, Mumbai, Bangalore About S&C - Global Network :- Accenture GN's Data & AI (AI Hub India) practice helps our clients grow their business in entirely new ways. Analytics enables our clients to achieve high performance through insights from data - insights that inform better decisions and strengthen customer relationships. From strategy to execution, Accenture works with organizations to develop analytic capabilities - from accessing and reporting on data to predictive modeling to outperform the competition. WHAT'S IN IT FOR YOU? An opportunity to work on high-visibility projects with top Pharma clients around the globe. Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything"from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Qualifications What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter expertise in various sub-segments of the LS industry. Develop assets and methodologies, point-of-view, research, or white papers for use by the team and the larger community. Acquire new skills that have utility across industry groups. Support strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for? Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills. Accenture is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, gender identity, or any other basis as protected by applicable law.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Regulatory Compliance Good to have skills : NA Minimum 7.5 year(s) of experience is required Educational Qualification : Regular 15 years full time education Project Role :Application Developer Project Role Description :Design, build and configure applications to meet business process and application requirements. Must have Skills :Regulatory ComplianceGood to Have Skills : No Function SpecializationJob Requirements :Key Responsibilities :1 In depth knowledge on Regulatory business processes, content, and data for Life sciences industry2 Prior experience on working on customer facing roles, leading and managing regulatory systems projects and programs3 Experience developing various projects deliverables not limited to current state assessment, RIM strategy and roadmap, high level process maps, BRDs and defining user stories4 Fair understanding on regulatory data flow in and out with various Industry standard boundary system Technical Experience :1 Strong knowledge on various modules of Regulatory systems eg:registration tracking, submissions, publishing ,archiving and reporting 2 Good communications and facilitation skills to organize workshops defining future RIM processes future state, requirements and IDMP data management 3 Prior experience with implementation of at least anyone of the regulatory systems:Generis, Documentum, Ennov Veeva RIM etc Professional Attributes :Good communication skill Educational Qualification:Regular 15 years full time educationAdditional Info : Qualification Regular 15 years full time education

Research & Development Consultant - Life Sciences and Health Join our team in Strategy consulting to find endless opportunities and solve our clients toughest" challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Life Sciences & Health, Industry Consulting, Capability Network I Areas of Work: Research & Development (R&D) | Level: Consultant | Location: Delhi, Gurgaon, Mumbai, Bangalore Years of Exp: 7 to 14 years Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your interest? Then, Accenture Strategy and Consulting is the right place for you to explore limitless possibilities. As a part of the Accenture Life Sciences practice , our 4000+ practitioners across the globe, help our clients make a meaningful impact on patients lives through New Science, novel medical technologies and better collaboration. Together, lets deliver more effective, affordable, personalized patient outcomes. In this practice, youll help drive our Life Sciences clients strategy and business planning efforts, with the following initiatives: Support delivery of small to medium-size teams to deliver management consulting projects for global clients. Responsibilities may include strategy, implementation, process design and change management for specific modules Support efforts global sales team to identify and win potential opportunities within the practice. Provide industry expertise in various sub-segments of the LS industry Develop assets and methodologies , point-of-view, research or white papers for use by the team and larger community. Acquire skills that have utility across industry groups. Support on strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with clients business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Acquire skills that have utility across industry groups. Bring your best skills forward to excel in the role: Industry expertise with a global top pharmaceutical, medical devices or biotechnology firm Familiarity or expertise with assets or tools in business consulting such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on Good functional and domain knowledge with relevant experience in the same area Make presentations wherever required to a known audience or client on functional aspects of his or her domain Should have worked with multi-functional teams and cross-functional stakeholders Ability to solve complex business problems and deliver client delight Strong writing skills to build point of views on current industry trends Strong program management skills Good analytical and problem-solving skills with an aptitude to learn quickly Good communication , interpersonal and presentation skills Read more about us. Recent Blogs Your experience counts! MBA from a Tier 1 institute or rich relevant industry experience 6+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences i ndustry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting ( R&D ), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, o perating m odel, b usiness p rocess mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite , pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Qualifications What’s in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything—from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions — underpinned by the world’s largest delivery network — Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients’ future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our Capability Network – a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our Capability Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world.?For more information visit https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team .

85% line balancing ratio with OEE improvement & Productivity in SKD, Finishing & Rim Assembly To reduction in change over time with SMED concept Zero failure in PDI, PLC Reduction in inventory Spares & Left Out Bikes Bicycle Industry exp Required Required Candidate profile Upgradation of skills of all team members through education & coaching Bench marking & monitoring of dept.. cost on daily basis zero accident on shop floor & analyses adherence of ISO & BSCI system

Research & Development Consultant – Life Sciences and Health Join our team in Strategy consulting to find endless opportunities and solve our clients toughest" challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Life Sciences & Health, Industry Consulting, Capability Network I Areas of Work: Research & Development (R&D) | Level: Consultant | Location: Delhi, Gurgaon, Mumbai, Bangalore Years of Exp: 3 -6 years Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your interest? Then, Accenture Strategy and Consulting is the right place for you to explore limitless possibilities. As a part of the Accenture Life Sciences practice , our 4000+ practitioners across the globe, help our clients make a meaningful impact on patients' lives through New Science, novel medical technologies and better collaboration. Together, let's deliver more effective, affordable, personalized patient outcomes. In this practice, you'll help drive our Life Sciences clients' strategy and business planning efforts, with the following initiatives: Support delivery of small to medium-size teams to deliver management consulting projects for global clients. Responsibilities may include strategy, implementation, process design and change management for specific modules Support efforts global sales team to identify and win potential opportunities within the practice. Provide industry expertise in various sub-segments of the LS industry Develop assets and methodologies , point-of-view, research or white papers for use by the team and larger community. Acquire skills that have utility across industry groups. Support on strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with client's business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Acquire skills that have utility across industry groups. Bring your best skills forward to excel in the role: Industry expertise with a global top pharmaceutical, medical devices or biotechnology firm Familiarity or expertise with assets or tools in business consulting such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on Good functional and domain knowledge with relevant experience in the same area Make presentations wherever required to a known audience or client on functional aspects of his or her domain Should have worked with multi-functional teams and cross-functional stakeholders Ability to solve complex business problems and deliver client delight Strong writing skills to build point of views on current industry trends Strong program management skills Good analytical and problem-solving skills with an aptitude to learn quickly Good communication , interpersonal and presentation skills Read more about us. Recent Blogs Qualifications Your experience counts! MBA from a Tier 1 institute or rich relevant industry experience 3 -6 years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences i ndustry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting ( R&D ), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, o perating m odel, b usiness p rocess mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite , pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable What’s in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything—from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions — underpinned by the world’s largest delivery network — Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients’ future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our Capability Network – a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our Capability Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. For more information visit https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team .

Research & Development Analyst – Life Sciences and Health Join our team in Strategy consulting to find endless opportunities and solve our clients toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Life Sciences & Health, Industry Consulting, Capability Network I Areas of Work: Research & Development (R&D) | Level: Analyst | Location: Delhi, Gurgaon, Mumbai, Bangalore Years of Exp: 1-3 years Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your interest? Then, Accenture Strategy and Consulting is the right place for you to explore limitless possibilities. As a part of the Accenture Life Sciences practice, our 4000+ practitioners across the globe, help our clients make a meaningful impact on patients' lives through New Science, novel medical technologies and better collaboration. Together, let's deliver more effective, affordable, personalized patient outcomes. In this practice, you'll help drive our Life Sciences clients' strategy and business planning efforts, with the following initiatives: Support to deliver management consulting projects for global clients. Acquire skills that have utility across industry groups. Support development of assets and methodologies, point-of-view, research, or white papers for use by the team and larger community. Take responsibility within Life Sciences industry group or across the Products group, help build the practice, track metrics, and so on. Work on proposals, business development efforts by coordinating with other colleagues Bring your best skills forward to excel in the role: Industry experience with a global top pharmaceutical, medical devices, or biotechnology firm Decent functional and domain knowledge with relevant experience in the same area Impeccable team management skills with an ability to engage effectively with multiple stakeholders Strong writing skills to build point of views on current industry trends Good analytical and problem-solving skills with an aptitude to learn quickly Excellent English oral and written skills Read more about us. Recent Blogs Your experience counts! MBA from a Tier 1 institute or rich relevant industry experience 2+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable What's in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything"”from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions "” underpinned by the world's largest delivery network "” Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients' future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategys services include those provided by our Capability Network – a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our Capability Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. For more information visit https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team. Qualifications MBA from a Tier 1 institute or rich relevant industry experience 2+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable