30 Regulations Knowledge Jobs - Page 2

About KPMG in India KPMG entities in India are professional services firm(s) affiliated with KPMG International Limited. Established in India in August 1993, KPMG has a network of offices in Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Jaipur, Hyderabad, Jaipur, Kochi, Kolkata, Mumbai, Noida, Pune, Vadodara, and Vijayawada. Leveraging global connections while staying informed about local laws, regulations, markets, and competition, our professionals aim to offer rapid, performance-based, industry-focused, and technology-enabled services to national and international clients. The services provided by KPMG entities in India reflect a deep understanding of global and local industries and extensive experience in the Indian business environment. QUALIFICATIONS Educational Qualification: BE / B Tech / ME / M Tech / MBA Equal employment opportunity information,

As a Data Standards Specialist at ICON plc, you will play a crucial role in supporting the standardization of data management practices. Your primary responsibility will involve creating and maintaining content in the Data Standards Catalog under guided supervision. You will collaborate with representatives from various functions, leveraging industry standards to develop clinical data collection instruments and associated checks. Your role will also involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Participation in relevant governance team meetings and providing input on standards as assigned will be essential. Collaborating with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy, ensuring compliance with regulations and internal governance procedures will be part of your responsibilities. As a subject matter expert (SME) for specific topics, you may provide ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing departments. Additionally, you will contribute to Data Management or cross-functional initiatives as needed and oversee CRO/FSP data managers and/or database development teams. You will represent the Data Standards team in various forums, including Data Standards Governance meetings, Clinical study team meetings, and Project update meetings. Demonstrating a foundational knowledge of Data Management and Data Standards processes, along with an awareness of industry best practices, is key to excelling in this role. Having a basic understanding of regulations like 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection is required. An ideal candidate would have a minimum of 2 years of clinical data standards experience in the biotechnology, pharmaceutical, or health-related industry. Possessing CDISC standards, SCDM certification, or Medidata RAVE certification is considered a plus. The role requires a Bachelor's degree in a Science, Health, Computing, or related field. At ICON, we value our employees and offer a competitive salary along with a range of benefits designed to promote well-being and work-life balance. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, discounted gym memberships, and health assessments. To learn more about the benefits of working at ICON, visit our careers website at https://careers.iconplc.com/benefits. If you are interested in the role but unsure if you meet all the requirements, we encourage you to apply as you may be exactly what we are looking for at ICON, whether for this position or other roles.,

Are you seeking a fresh opportunity to demonstrate your analytical, client advisory, communication, and relationship management skills An excellent position within our Firmwide Compensation classic team in the Human Capital Management (HCM) division awaits you. Your intellectual curiosity and innovative problem-solving approach will be highly valued, directly impacting the success of our most valuable asset: the people of our firm. HCM, as a division, plays a vital role in supporting business growth and change at Goldman Sachs by recruiting, developing, and rewarding the individuals within the organization. Our teams are involved in advising, designing, and implementing strategies, processes, and technologies aimed at advancing the professional growth of our people, driving productivity, and achieving superior results for the firm and our clients. The Firmwide Compensation Team is responsible for developing and implementing the compensation philosophy, policies, and practices globally. This team supports the firm's efforts to attract and retain top talent, requiring collaboration with various departments such as Controllers, Legal, and Tax. Additionally, support is provided to other HCM functions, including HCM Business Partners, Recruitment, Employee Relations, Executive Compensation, Equity Compensation, and Global Mobility Services. Your Role: - Act as a strategic advisor to the firm in India, designing, implementing, and managing compensation programs in alignment with firm and divisional strategies - Participate in benchmarking studies to ensure competitive compensation strategies, sharing key findings with senior leadership - Collaborate with the Firmwide Compensation team to identify improvement and automation opportunities, drive process changes, and enhance efficiencies - Analyze hiring and attrition trends, offering insights to senior stakeholders on attracting and retaining top talent - Partner with cross-functional HCM teams to structure compensation packages for new hires - Work closely with finance and divisions to manage compensation budgets and centrally administer the year-end compensation process Qualifications: - Bachelor's or master's degree in Human Resources, Business Administration, Finance, or a related field - 4-5 years of relevant work experience - Proficiency in working with and analyzing large datasets to present compelling results - Ability to handle multiple priorities while delivering high-quality work - Strong understanding of compensation practices and regulations - Organized, detail-oriented, and excellent at follow-through - Strong written and verbal communication skills to build relationships and act as a liaison across HCM groups - Proactive in anticipating potential issues and escalating when necessary - Capable of working independently and in a fast-paced global team environment,

ICON plc is driving efficiencies through standardizing data management practices. As a Data Standards Specialist, you will play a crucial role in creating and maintaining content in the Data Standards Catalog. Working under guided supervision, you will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your responsibilities will include updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. You will actively participate in governance team meetings, providing input on assigned standards. Collaborating with Senior/Principal Data Standards Specialists or Managers, you will help implement data standards strategy while ensuring compliance with regulations and internal governance procedures. In addition, you may serve as a subject matter expert (SME) for specific topics. You will offer ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing teams. Your role may also involve contributing to Data Management or cross-functional initiatives as required. Furthermore, you might oversee and hold accountable CRO/FSP data managers and/or database development teams. As part of the Data Standards team, you will represent ICON in various forums including Data Standards Governance meetings, clinical study team meetings, and project update meetings. To be successful in this role, you should demonstrate a foundational knowledge of Data Management and Data Standards processes, along with an understanding of industry best practices. A basic understanding of regulations such as 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards is required. Possession of CDISC standards, SCDM certification, or Medidata RAVE certification will be advantageous. A minimum of 2 years of clinical data standards experience in biotechnology, pharmaceutical, or health-related industry is necessary. Education-wise, a Bachelor's degree in a Science, Health, Computing, or related field is required. At ICON, we value our people and strive to build a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a range of benefits tailored to promote well-being and work-life balance for you and your family. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, gym memberships, and health assessments, among others. If you are interested in the role but unsure if you meet all requirements, we encourage you to apply as you may be exactly what we are looking for at ICON. Visit our careers website to learn more about the benefits of working with us: https://careers.iconplc.com/benefits For more information about reasonable accommodations, visit: https://careers.iconplc.com/reasonable-accommodations,

INTOX Pvt. Ltd. is a premier Indian toxicological Contract Research Organization (CRO) located in Pune. With OECD GLP Certification since 2007, INTOX operates in multiple areas including mammalian toxicology, bioanalytical studies, mutagenicity, environmental toxicity, analytical chemistry, and physical-chemical studies. This full-time on-site role is for a Head of Quality Assurance at INTOX Pvt. Ltd. in Pune. As the Head of Quality Assurance, you will be responsible for overseeing day-to-day quality control and quality auditing activities. Leveraging your analytical skills and expertise in quality management, you will ensure high-quality standards and compliance with regulations. Leading the Quality Assurance team and driving quality improvement initiatives will be key aspects of this role. Qualifications for this position include proficiency in Quality Control and Quality Auditing, strong analytical skills, experience in Quality Management and Quality Assurance, knowledge of relevant regulations and guidelines, excellent communication and leadership skills, ability to work effectively in a team, attention to detail, problem-solving abilities, experience in the CRO industry, and 15+ years of experience in QAU in a GLP environment. A Master's degree in Life Science along with a PhD is preferred.,