581 Ich Jobs - Page 19

What you will do Let’s do this. Let’s change the world. In this vital role you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles & Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) May provide functional area input for Global Regulatory Plan and team goals May work with contract and freelance writers May participate in training and mentoring of junior medical writers May participate in departmental and cross-departmental initiatives, as appropriate. Generate document timelines, with team input Keep abreast of relevant professional information and technology What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of directly related experience OR Bachelor’s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Functional Skills: Proficiency with word processing and other Microsoft Office Programs Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds; Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions; Understanding and application of principles, concepts, theories and standards of scientific/technical field. Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance’s and requirements. Soft Skills: Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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 an accommodation. 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 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

What you will do Let’s do this. Let’s change the world. In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Ensures quality of complaint records Applies analytical abilities to evaluate complex situations using multiple sources of information Execution of regulatory and SOP requirements Anticipates and prevents potential issues with regulators Provides guidance and technical advice Evaluates subject matter expert assessments Raises potential Quality issues to Management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR , Master’s degree and 4 to 6 years of Specialist Quality Complaints experience OR , Bachelor’s degree and 6 to 8 years of Specialist Quality Complaints experience OR , Diploma and 10 to 12 years of Specialist Quality Complaints experience Preferred Qualifications: Quality and manufacturing experience in biotech or pharmaceutical industry Ability to oversee multiple projects simultaneously Ability to successfully handle workload to timelines Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) 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.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Adaptable and flexibleAgility for quick learningAbility to work well in a team Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug safety associateDrug safety associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs LCM with Veeva skill set of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to perform under pressureProblem-solving skillsDetail orientationResults orientationStrong analytical skillsLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Veeva Regulatory Suite experienceCollect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available).Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Masters in actuarial science

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available).Adaptable and flexible.Ability to perform under pressure.Problem-solving skills.Ability to establish strong client relationship.Agility for quick learning.Experience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Masters in actuarial science

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 : SAP HCM Payroll Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that solutions are effectively implemented across multiple teams, while maintaining a focus on quality and efficiency in application delivery. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure alignment with strategic goals. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP HCM Payroll.- Strong understanding of payroll processing and compliance regulations.- Experience with SAP HCM modules and integration with other systems.- Ability to troubleshoot and resolve application issues effectively.- Familiarity with project management methodologies. Additional Information:- The candidate should have minimum 12 years of experience in SAP HCM Payroll.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

About Us Tsaaro Consulting's prime focus is on Data Privacy and Security Our team of specialist Data Privacy Consultants, Information Security Consultants, and penetration testers help and advise our Clients to make running a secure business easier with high efficiency Everything We do is tailored to the individual, and organisational requirements, aligned with their budget and resource challenges We take a pragmatic, risk-based approach to provide our clients with real-world, workable advice, guidance, and support That helps them to deal with a wide range of security and privacy-related challenges At Tsaaro, we adopt a pragmatic, risk-based strategy to deliver practical and effective advice By providing real-world guidance, support, and actionable recommendations, we confidently equip our clients to address a broad spectrum of security and privacy challenges Looking to take your career in a new, high-impact directionTsaaro Consulting is seeking for a highly skilled and experienced GRC Analyst, this role is for those eager to transition into data privacy and information security, with hands-on experience and mentorship from industry experts Responsibilities Assist in the development, implementation, and continuous improvement of the Information Security Management System (ISMS) in accordance with ISO 27001 standards Monitor and ensure compliance with ISO 27001, making sure controls are in place and effectively operating across the organization Conduct regular assessments to ensure adherence to regulatory, contractual, and internal security requirements Coordinate internal audits and provide support for external ISO 27001 audits Prepare documentation, assist with gathering evidence, and address findings to ensure timely closure of audit actions Maintain and update ISMS documentation, policies, and procedures Ensure that security controls, risk assessments, and audit records are accurately documented and up to date Support the delivery of security awareness and training programs related to ISO 27001 standards Foster a culture of security awareness across the organization Support incident response processes and prepare crisis management plans, ensuring incidents are logged, analysed, and resolved Participate in root cause analysis and implement corrective actions to prevent recurrence Collaborate with cross-functional teams to identify, assess, and prioritise security risks Assist in developing risk mitigation strategies and track the progress of risk treatment plans Proactively identify opportunities to enhance the ISMS framework, suggesting improvements to policies, processes, and tools to ensure they are efficient and effective Requirements Minimum of 2 years in Governance, Risk, and Compliance (GRC) roles, with a focus on ISMS and ISO 27001 Bachelors degree in Information Security, Computer Science, Business Administration, or a related field (preferred) Excellent analytical and problem-solving skills Strong understanding of regulatory requirements and industry standards related to information security Proficiency in risk assessment methodologies and risk management practices Strong communication and interpersonal skills Ability to work effectively both independently and as part of a team Experience with security incident response and crisis management Familiarity with data protection regulations and privacy laws Certification in ISO 27001 Lead Auditor or Lead Implementer (preferred) Experience in developing and delivering security awareness training programs Benefits Competitive salary and performance-based bonuses Professional development opportunities, including training and certifications Flexible working hours Collaborative and inclusive work environment Opportunity to work with a passionate team dedicated to making a difference in data privacy and security check(event) ; career-website-detail-template-2 => apply(record id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#6875E2;border-color:#6875E2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered="">

About Us Tsaaro Consulting's prime focus is on Data Privacy and Security Our team of specialist Data Privacy Consultants, Information Security Consultants, and penetration testers help and advise our Clients to make running a secure business easier with high efficiency Everything We do is tailored to the individual, and organisational requirements, aligned with their budget and resource challenges We take a pragmatic, risk-based approach to provide our clients with real-world, workable advice, guidance, and support That helps them to deal with a wide range of security and privacy-related challenges At Tsaaro, we adopt a pragmatic, risk-based strategy to deliver practical and effective advice By providing real-world guidance, support, and actionable recommendations, we confidently equip our clients to address a broad spectrum of security and privacy challenges Looking to take your career in a new, high-impact directionTsaaro Consulting is seeking for a highly skilled and experienced GRC Analyst, this role is for those eager to transition into data privacy and information security, with hands-on experience and mentorship from industry experts Responsibilities Assist in the development, implementation, and continuous improvement of the Information Security Management System (ISMS) in accordance with ISO 27001 standards Monitor and ensure compliance with ISO 27001, making sure controls are in place and effectively operating across the organization Conduct regular assessments to ensure adherence to regulatory, contractual, and internal security requirements Coordinate internal audits and provide support for external ISO 27001 audits Prepare documentation, assist with gathering evidence, and address findings to ensure timely closure of audit actions Maintain and update ISMS documentation, policies, and procedures Ensure that security controls, risk assessments, and audit records are accurately documented and up to date Support the delivery of security awareness and training programs related to ISO 27001 standards Foster a culture of security awareness across the organization Support incident response processes and prepare crisis management plans, ensuring incidents are logged, analysed, and resolved Participate in root cause analysis and implement corrective actions to prevent recurrence Collaborate with cross-functional teams to identify, assess, and prioritise security risks Assist in developing risk mitigation strategies and track the progress of risk treatment plans Proactively identify opportunities to enhance the ISMS framework, suggesting improvements to policies, processes, and tools to ensure they are efficient and effective Requirements Minimum of 2 years in Governance, Risk, and Compliance (GRC) roles, with a focus on ISMS and ISO 27001 Bachelors degree in Information Security, Computer Science, Business Administration, or a related field (preferred) Excellent analytical and problem-solving skills Strong understanding of regulatory requirements and industry standards related to information security Proficiency in risk assessment methodologies and risk management practices Strong communication and interpersonal skills Ability to work effectively both independently and as part of a team Experience with security incident response and crisis management Familiarity with data protection regulations and privacy laws Certification in ISO 27001 Lead Auditor or Lead Implementer (preferred) Experience in developing and delivering security awareness training programs Benefits Competitive salary and performance-based bonuses Professional development opportunities, including training and certifications Flexible working hours Collaborative and inclusive work environment Opportunity to work with a passionate team dedicated to making a difference in data privacy and security check(event) ; career-website-detail-template-2 => apply(record id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#6875E2;border-color:#6875E2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered="">

IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.

Deva Institute of Healthcare and Research Pvt Ltd is looking for Clinical Research Coordinator to join our dynamic team and embark on a rewarding career journey. Coordinate and manage clinical trials from initiation to completion, ensuring compliance with regulatory guidelines and study protocols Recruit, screen, and enroll study participants while maintaining accurate documentation and records Monitor patient safety, manage informed consent, and schedule follow-ups Communicate with investigators, sponsors, and regulatory authorities to ensure timely updates and reporting Maintain study supplies, track data collection, and support data analysis, ensuring high-quality and ethical research practices throughout the study

Wte Infra Projects Pvt Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Ability to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) OperationsRequirements:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing prioritiesFlexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft WordBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) OperationsRequirements:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Apollo Pipes Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to RD staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines. Qualification M. Pharm, M.Sc PhD Additional Information Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.

Skill required: Group Core Benefits - Group Disability Insurance Designation: Insurance Operations Senior Analyst Qualifications: Bachelor of Dental Surgery/Bachelor of Pharmacy/Bachelor in Physiotherapy Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do We help insurers redefine their customer experience while accelerating their innovation agenda to drive sustainable growth by transforming to an intelligent operating model. Intelligent Insurance Operations combines our advisory, technology, and operations expertise, global scale, and robust ecosystem with our insurance transformation capabilities. It is structured to address the scope and complexity of the ever-changing insurance environment and offers a flexible operating model that can meet the unique needs of each market segment.The benefits of having a strong core include injury prevention, reduction of back pain, improved lifting mechanics, balance, stability, and posture, as well as improved athletic performance.Group disability coverage is tied to employment. If change or loss of job, the coverage is not portable. The cost of group coverage can also change from year to year. It is a sort of insurance that pays out if a policyholder is unable to work and earn an income due to a disability. What are we looking for Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressure0-5 years of experience in Medical Underwriting work.Possess excellent medical knowledge, including a strong grasp of medical terminologies and complex and complex disease condition.Knowledge of MS Office Tools and good computer knowledge.Graduate/Postgraduate in Life Sciences, B. Pharma, Bachelor in Physiotherapy, BHMS.Open to flexible shifts based on business requirements.Good verbal & written communication skillsGood typing skills and attention to detail.Good time management skills. Ability to work independently Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shiftsEvaluating the eligibility of applicants seeking an insurance policy. Reviewing each person s medical history and other factors such as age.Calculating individual risk and determining appropriate coverage and premium amounts.Assessing the risk involved in insuring an individual.Reviewing application files for life & disability products policies and determining eligibility coverage, premium rates, and exclusion policies.Complies with all regulatory requirements, procedures, and Federal/State/Local regulations.Review medical reports, data, and other records to assess the risk involved in insuring a potential policyholder.Ensure Quality Control standards that have been set are adhered to.Excellent organizational skills with ability to identify and prioritize high value transactions.Completing assigned responsibilities and projects within timelines apart from managing daily BAU. Qualification Bachelor of Dental Surgery,Bachelor of Pharmacy,Bachelor in Physiotherapy

Skill required: Group Core Benefits - Group Disability Insurance Designation: Insurance Operations Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do We help insurers redefine their customer experience while accelerating their innovation agenda to drive sustainable growth by transforming to an intelligent operating model. Intelligent Insurance Operations combines our advisory, technology, and operations expertise, global scale, and robust ecosystem with our insurance transformation capabilities. It is structured to address the scope and complexity of the ever-changing insurance environment and offers a flexible operating model that can meet the unique needs of each market segment.The benefits of having a strong core include injury prevention, reduction of back pain, improved lifting mechanics, balance, stability, and posture, as well as improved athletic performance.Group disability coverage is tied to employment. If change or loss of job, the coverage is not portable. The cost of group coverage can also change from year to year. It is a sort of insurance that pays out if a policyholder is unable to work and earn an income due to a disability. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to work well in a teamPrioritization of workloadTower:Group InsuranceLevel 1:Employee BenefitLevel 2:Claims ProcessingMust have/ minimum requirement2+ years of experience in Insurance Disability Claims Processing.Knowledge of MS Office Tools and good computer knowledge. Roles & Responsibilities:Processing Disability insurance claims, calculating overpayments and Underpayments.Review and assess complex Disability claims to determine benefits and eligibility for payment.Research and verify claims information including policy details, claims document validation, calculating benefit amount and other relevant documentation.Identify the correct payee or beneficiary to release the claims payment.Complies with all regulatory requirements, procedures, and Federal/State/Local regulations.Research on any queries/ requests sent by the Business Partners/Client Support Teams and replying the same with minimum response time.Taking active participation in process improvements and automation.Ensure Quality Control standards that have been set are adhered to.Excellent organizational skills with ability to identify and prioritize high value transactions.Completing assigned responsibilities and projects within timelines apart from managing daily BAU.Skillset:Graduate in any stream.Open to flexible shifts based on business requirements.Good verbal & written communication skillsGood typing skills and attention to detail.Time management skills. Ability to work independently Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Job Summary We are seeking a Process Specialist with 4 to 5 years of experience in HealthCare Products to join our team. The ideal candidate will have expertise in Prov Privileges excl Hospital Demo Changes Credentialing and Re-credentialing by Calls . This role requires working in a hybrid model with night shifts. The candidate will play a crucial role in ensuring the smooth operation of healthcare processes and contribute to the overall efficiency and effectiveness of our services. Responsibilities Oversee the management of healthcare products to ensure compliance with industry standards and regulations. Provide expertise in Prov Privileges excl Hospital to maintain accurate provider information. Manage demo changes to ensure that all demographic data is up-to-date and accurate. Handle credentialing and re-credentialing processes to ensure that all providers meet the necessary qualifications and standards. Collaborate with various departments to streamline healthcare processes and improve overall efficiency. Conduct regular audits to ensure compliance with healthcare regulations and standards. Develop and implement process improvements to enhance the quality of healthcare services. Provide training and support to team members on healthcare processes and procedures. Monitor and analyze process performance to identify areas for improvement. Ensure that all healthcare processes are documented and maintained accurately. Work closely with healthcare providers to address any issues or concerns related to credentialing and privileges. Participate in the development and implementation of healthcare policies and procedures. Maintain up-to-date knowledge of industry trends and best practices in healthcare process management. Qualifications Possess a minimum of 4 years of experience in healthcare products management. Demonstrate expertise in Prov Privileges excl Hospital demo changes credentialing and re-credentialing. Have a strong understanding of healthcare regulations and standards. Exhibit excellent communication and collaboration skills. Show proficiency in process improvement methodologies. Display strong analytical and problem-solving abilities. Certifications Required Certified Provider Credentialing Specialist (CPCS) or equivalent certification is required.

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships with stakeholders, associations, etc. through appropriate management of expectations and objectives, ensuring consistent and effective communication. Will handle the Invoicing, NFA, payment disbursement activities, etc. Draft representations, communication for various stakeholders. Additional Responsibilities: Supporting corporate communications efforts with different stakeholders. Monitoring key industry events and, ensuring ENGIEs participation at appropriate levels to enhance visibility and influence.