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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

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Project Role : Quality Engineer (Tester) Project Role Description : Enables full stack solutions through multi-disciplinary team planning and ecosystem integration to accelerate delivery and drive quality across the application lifecycle. Performs continuous testing for security, API, and regression suite. Creates automation strategy, automated scripts and supports data and environment configuration. Participates in code reviews, monitors, and reports defects to support continuous improvement activities for the end-to-end testing process. Must have skills : Veeva Vault Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 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 : Veeva Vault Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 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 : Veeva Vault Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText. -The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

Project Role : Application Designer Project Role Description : Assist in defining requirements and designing applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Veeva Vault Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

Project Role : Quality Engineer (Tester) Project Role Description : Enables full stack solutions through multi-disciplinary team planning and ecosystem integration to accelerate delivery and drive quality across the application lifecycle. Performs continuous testing for security, API, and regression suite. Creates automation strategy, automated scripts and supports data and environment configuration. Participates in code reviews, monitors, and reports defects to support continuous improvement activities for the end-to-end testing process. Must have skills : Veeva Vault Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 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 : Veeva Vault Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

Project Role : Application Designer Project Role Description : Assist in defining requirements and designing applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Veeva Vault Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master’s/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality standards for products or services. Author or review Ocugen quality standards, procedures, and work instructions. Participate in cross - functional teams to establish and enhance the quality systems and support for managing high levels of quality compliance at contract manufacturers. Build strategic relationships with CDMOs (Contract Development and Manufacturing Organization) within the Quality organization and participate in Business Review Meetings to ensure Quality issues are identified, managed, addressed, and escalated, as necessary. Establish, maintain , and monitor supplier files including Quality Agreements with CDMOs and directly related suppliers to the CDMOs. Responsible for the quality review and approval of master batch records, executed batch records, reports, protocols, analytical methods, change controls, investigations, OOS (Out of Specifications), OOT (Out of Trends), deviations, and CAPA for development, clinical and commercial processes, assess impact and provide quality oversight of implementation activities. Support RCA (Root Cause Analysis and associated tools) and product impact assessments for investigations resulting from deviations and OOS events. Oversee, review, and approve quality testing processes and identify gaps in testing. Oversee, review, and approve manufacturing processes and identify gaps in manufacturing. Overseeing, reviewing, and approving quality events and ensuring effectiveness is part of business improvements. Staying up to date with relevant laws and regulations to ensure compliance. Train other employees in quality standards and procedures and handle quality reports, documentation, and records. Collect and analyze QA data and prepare monthly and quarterly metrics regularly. Work with GMP vendors to ensure their quality and conduct vendor audit if necessary. Participate in internal audit program and followup on CAPA (Corrective and Preventive Actions) assigned to closure within the timeframe. Eliminating products that are not up to standards and finding the reasons for product problems Identify potential risks before they become a problem, focusing on root cause analysis and preventive action Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement initiatives. Qualifications: Bachelor' or Masters in Biology, Chemistry, or related fields. At least eight (8) years for BS and five (5) years for MS GMP experience with a focus on quality with substantial operational and GMP experience supporting Biologics/Vaccines/Cell and gene therapy products. At least five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; at least two (2) years managing Phase 1-3 clinical trials. Prior experience and a broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. In-depth knowledge of the international regulatory landscape is preferred. In-depth knowledge of and ability to interpret and apply GMP EU, FDA (Food and Drug Administration), USP (United States Pharmacopeia), Phr. Eu., WHO, PMDA, and ICH regulations and guidelines. Excellent written, verbal, listening, and interpersonal communication skills. Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants, and contractors). Integrated Quality leader who can build strong collegial relationships cross-departmentally while effectively and courageously driving regulatory compliance. Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment. Proven background in GxP and GMP audit management, risk management, mitigation, and controls. Proficient in Veeva Vault systems (QualityDocs, Training, eQMS, RIM, etc.). Working conditions This position operates primarily in an office setting and may include 10% of travel. This position is in Hyderabad, INDIA (on-site). This position will work in US business hours. Physical requirements This is a sedentary role.

Platform Engineer / Business Analyst - Veeva R&D Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Purpose and Scope: As a Platform Engineer of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components Digital Capability and Digital Execution. Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. As a business analyst, you will be responsible for understanding the needs of the end users, across commercial and medical business domains, and utilizing your knowledge and experience in Veeva R&D suite of products to demonstrate to end users how best to meet their requirements. You will then translate these requirements into well-defined user stories that the system engineers can rely on to develop, test, and deploy the required changes made to the systems. Essential Job Responsibilities: Business Requirements Analysis: Collaborate with business stakeholders to understand their needs, goals, and objectives. Analyse business processes and workflows to identify improvement opportunities and define requirements for solutions. Technical Specification Development: Translate business requirements into detailed technical specifications that guide the development of software applications, systems, or processes. Ensure that these specifications meet both the business needs and technical standards. Solution Design and Recommendation: Work with Digital and software development teams to design solutions that fulfil business requirements. Evaluate potential technical solutions for feasibility, cost-effectiveness, and alignment with business objectives. Stakeholder Collaboration: Serve as a liaison between business units and technical teams to ensure clear communication and understanding of project goals, requirements, and constraints. Facilitate meetings and discussions to gather feedback and consensus. Project Management Support: Assist in project management tasks, such as planning, scheduling, and tracking progress. Ensure that projects stay on track to meet deadlines and budget constraints. Testing and Quality Assurance: Participate in the testing of developed solutions to ensure they meet the defined requirements and standards. Assist in identifying and documenting bugs or issues for resolution. Training and Support: Develop training materials and provide support to users on new systems or applications. Ensure that end-users are equipped to use the new solutions effectively. Documentation: Create and maintain documentation related to business requirements, technical specifications, project plans, and reports to ensure knowledge is captured and shared. Requirements Qualifications: Required Minimum 3 years of experience in commercial and medical business analysis at a Life Science organization, focusing on Veeva R&D suite of products, including Vault Clinical, RIM, Quality, Safety. Knowledge and experience in R&D domains in Life Science / Pharma industry Demonstrated experience in business analysis, technical analysis, or a related area, demonstrating a track record of bridging business needs with technical solutions. Analytical Skills: Strong analytical and problem-solving skills to understand complex business issues and develop appropriate technical solutions. Experience in Agile methodology, DevOps, CI/CD principles and practices. Technical Knowledge: Good understanding of information technology, software development life cycles, and architectural frameworks. Communication Skills: Excellent verbal and written communication skills, with the ability to convey technical concepts to non-technical stakeholders and vice versa. Collaboration: Ability to work effectively in a team environment, collaborating with diverse groups of stakeholders, including business users, Digital professionals, and management. Attention to Detail: Precision in documenting requirements, specifications, and project details to ensure clarity and alignment with objectives. Adaptability: Flexibility to adapt to changing requirements, technologies, and project priorities. Preferred Veeva Certified Administrator Familiarity with programming languages, databases, and software development tools is beneficial. Certifications in Agile delivery methodologies (e.g., SCRUM, SAFe) Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery

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, 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

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team man a gement. May m anage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development, Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment May manage staff Knowledge and Skills Regulatory CMC- specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

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.

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 .

Specialist, 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. Requirements 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 Required Qualifications: Bachelors Degree, preferably in Business, Library/Information Science or related field, or related experience and/or training. 4+ 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: 5+ 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 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 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 companys’ Responsible Flexibility Guidelines.