734 Ich-Gcp Guidelines Jobs - Page 10

Roles and Responsibility Publish regulatory submissions according to company guidelines and timelines. Ensure compliance with regulatory requirements and industry standards. Collaborate with cross-functional teams to meet submission goals. Review and edit regulatory documents for accuracy and completeness. Maintain accurate records of submissions and publications. Stay updated with changing regulatory requirements and guidelines. Job Requirements Minimum 2 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and industry standards. Excellent publishing and communication skills. Ability to work independently and as part of a team. Stron...

We are currently seeking a Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. You will ensure compliance with regulatory requirements and contribute to the effective management of safety data to support patient safety and regulatory compliance. What You Will Be Doing: Preparing and reviewing safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards. Collecting and analyzing adverse event data ...

Skills : Oracle Risk Management Experience in SOX compliance, internal controls, or auditing Knowledge, SOX regulations, internal controls, and accounting principles Notice Period: 0- 30 days

Main responsibilities: Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency. Essential Job duties and responsibilities: Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of s...

We are looking for a highly skilled Medical Document Writer/Reviewer with 2 to 5 years of experience to join our team in Mumbai. The ideal candidate will have a strong background in medical writing and reviewing, with excellent communication and analytical skills. Roles and Responsibility Develop high-quality medical documents, including clinical trial protocols, informed consent forms, and case study reports. Review and edit medical documents for accuracy, clarity, and compliance with regulatory requirements. Collaborate with cross-functional teams, including physicians, researchers, and other stakeholders, to ensure timely delivery of high-quality documents. Conduct thorough reviews of med...

We are looking for a highly skilled and experienced Regulatory Document Publisher to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in [location to be specified]. The ideal candidate will have 2-6 years of experience in the IT Service & Consulting industry. Roles and Responsibility Publish regulatory documents accurately and efficiently. Ensure compliance with relevant regulations and standards. Collaborate with cross-functional teams to meet business objectives. Develop and maintain documentation processes and procedures. Review and edit documents for accuracy, completeness, and consistency. Maintain confidentiality and security of sensitive information. Job Requir...

We are looking for a highly skilled Regulatory Medical Writer with 3 to 8 years of experience to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in the IT Service & Consulting industry. Roles and Responsibility Develop high-quality regulatory documents, including clinical trial applications, marketing authorizations, and other related submissions. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company standards. Conduct thorough research and analysis of regulatory guidelines, laws, and regulations to inform document content. Create clear, concise, and well-structured documents that meet regulatory requirements. Review an...

We are looking for a highly skilled and experienced Clinical Data Reconciliation Specialist to join our team at Gratitude India Manpower Consultants Pvt. Ltd., an IT Service & Consulting company based in [location to be specified]. The ideal candidate will have 4-6 years of experience in clinical data reconciliation. Roles and Responsibility Manage and oversee the clinical data reconciliation process to ensure accuracy and quality. Develop and implement effective data reconciliation strategies to meet project requirements. Collaborate with cross-functional teams to identify and resolve data discrepancies. Analyze and report on data reconciliation results, identifying trends and areas for imp...

We are looking for a highly skilled Regulatory Document Publisher to join our team at Gratitude India Manpower Consultants Pvt. Ltd., with 5-8 years of experience in the IT Service & Consulting industry. Roles and Responsibility Publish regulatory documents accurately and efficiently, ensuring compliance with relevant regulations. Collaborate with cross-functional teams to ensure seamless document publication processes. Develop and maintain expertise in regulatory requirements and guidelines. Review and edit documents for accuracy, clarity, and adherence to standards. Ensure timely delivery of high-quality documents that meet client expectations. Stay updated with changes in regulatory requi...

We are looking for a highly skilled and experienced Clinical Data Reconciliation Specialist to join our team at Gratitude India Manpower Consultants Pvt. Ltd., an IT Service & Consulting company based in [location to be specified]. The ideal candidate will have 3-4 years of experience in clinical data reconciliation. Roles and Responsibility Manage and oversee the clinical data reconciliation process to ensure accuracy and quality. Develop and implement effective data reconciliation strategies to meet project requirements. Collaborate with cross-functional teams to identify and resolve data discrepancies. Analyze and report on data reconciliation results, identifying trends and areas for imp...

We are looking for a highly skilled and experienced Clinical Data Reconciliation Specialist to join our team at Gratitude India Manpower Consultants Pvt. Ltd., an IT Service & Consulting company based in [location to be specified]. The ideal candidate will have 5-10 years of experience in clinical data reconciliation. Roles and Responsibility Manage and oversee the clinical data reconciliation process to ensure accuracy and quality. Develop and implement effective data reconciliation strategies and procedures. Collaborate with cross-functional teams to identify and resolve data discrepancies. Analyze and interpret complex data sets to identify trends and patterns. Develop and maintain docume...

We are looking for a skilled Clinical Data Manager with expertise in Veeva EDC to join our team at Gratitude India Manpower Consultants Pvt. Ltd. The ideal candidate will have a strong background in the IT Service & Consulting industry and 2-7 years of experience. Roles and Responsibility Manage and oversee clinical data management activities, ensuring compliance with regulatory requirements. Develop and implement effective data management plans to ensure data quality and integrity. Collaborate with cross-functional teams to identify and resolve data-related issues. Conduct regular audits to ensure adherence to data management standards. Provide training and support to staff on data manageme...

We are looking for a highly skilled Regulatory Medical Writer with 1 to 6 years of experience to join our team in Mumbai. The ideal candidate will have a strong background in regulatory affairs and medical writing, with excellent communication and analytical skills. Roles and Responsibility Develop high-quality regulatory documents, including clinical study reports, marketing authorizations, and other related materials. Collaborate with cross-functional teams, including regulatory affairs, product development, and clinical operations. Conduct thorough reviews of regulatory documents to ensure accuracy, completeness, and compliance with regulatory requirements. Stay up-to-date with changing r...

We are looking for a skilled Clinical Data Manager with expertise in Veeva EDC to join our team at Gratitude India Manpower Consultants Pvt. Ltd. The ideal candidate will have a strong background in clinical data management and experience working with IT Service & Consulting companies. Roles and Responsibility Manage and oversee the development, implementation, and maintenance of clinical databases using Veeva EDC. Ensure data quality, integrity, and compliance with regulatory requirements. Collaborate with cross-functional teams to ensure seamless integration of clinical data into larger systems. Develop and implement data management plans, procedures, and standards. Conduct regular audits ...

Roles and Responsibility Develop high-quality medical documents, including clinical trial protocols, informed consent forms, and case study reports. Review and edit medical documents for accuracy, clarity, and compliance with regulatory requirements. Collaborate with cross-functional teams, including clinicians, researchers, and statisticians, to ensure timely delivery of documents. Conduct thorough reviews of documents to identify areas for improvement and implement changes as needed. Stay up-to-date with industry trends and developments in medical research and technology. Participate in document development activities, including creating templates, guidelines, and standard operating proced...

Roles and Responsibility Develop high-quality medical writing content for various reports, including Aggregate Reports. Collaborate with cross-functional teams to ensure timely delivery of projects. Conduct thorough research and analysis to stay updated on the latest developments in Pharmacovigilance. Create engaging and informative content that meets client requirements. Edit and review content for accuracy, clarity, and consistency. Work closely with clients to understand their needs and deliver tailored solutions. Job Requirements Minimum 2 years of experience in medical writing, preferably in Pharmacovigilance or Aggregate Reports. Strong understanding of medical terminology, regulations...

Roles and Responsibility Monitor medical enquiries and respond to customer inquiries professionally. Provide excellent customer service and ensure high customer satisfaction. Collaborate with internal teams to resolve customer complaints and concerns. Develop and maintain strong relationships with customers and stakeholders. Analyze customer feedback and suggest improvements to processes and procedures. Ensure compliance with company policies and procedures. Job Requirements Strong communication and interpersonal skills are essential. Ability to work in a fast-paced environment and meet deadlines is required. Excellent problem-solving and analytical skills are necessary. Strong attention to ...

Roles and Responsibility Manage and oversee the collection, review, and reporting of clinical trial data. Develop and implement effective data management plans and procedures. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct quality control checks on data accuracy and integrity. Provide training and support to staff members on data management best practices. Ensure timely delivery of high-quality data products to stakeholders. Job Requirements Strong knowledge of Good Clinical Practice (GCP) principles and regulations. Experience with clinical trial databases and data management systems. Excellent analytical and problem-solving skills with at...

Roles and Responsibility Develop and implement effective medical monitoring strategies for clinical trials. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct thorough reviews of medical data to identify trends and potential issues. Provide expert guidance on medical aspects of clinical development projects. Ensure timely reporting of medical information to stakeholders. Stay updated with changing regulations and guidelines related to medical monitoring. Job Requirements Strong knowledge of clinical development principles and practices. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment. Eff...

Roles and Responsibility Provide exceptional customer service and support to passengers. Handle passenger inquiries and resolve issues professionally and courteously. Collaborate with other teams to ensure seamless operations and high-quality service delivery. Develop and maintain thorough knowledge of airline procedures and protocols. Assist passengers with baggage handling and boarding processes. Ensure compliance with company policies and procedures. Job Requirements Minimum 2 years of experience in a related field, preferably in the aviation industry. Strong communication and interpersonal skills are essential. Ability to work well under pressure and handle multiple tasks simultaneously....

Roles and Responsibility Manage and oversee the collection, review, and reporting of clinical trial data. Develop and implement effective data management plans and procedures. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct quality control checks on data accuracy and integrity. Provide training and support to staff on data management best practices. Ensure timely delivery of high-quality data products to stakeholders. Job Requirements Strong knowledge of Good Clinical Practice (GCP) principles and regulations. Experience with clinical trial databases and data management systems. Excellent analytical and problem-solving skills with attention ...

Roles and Responsibility Manage and oversee the clinical data reconciliation process to ensure accuracy and quality. Develop and implement effective data reconciliation strategies to meet business objectives. Collaborate with cross-functional teams to identify and resolve data discrepancies. Analyze and report on data reconciliation metrics to stakeholders. Ensure compliance with regulatory requirements and company policies. Continuously monitor and improve the data reconciliation process to enhance efficiency. Job Requirements Strong understanding of clinical data management principles and practices. Experience with data reconciliation tools and technologies. Excellent analytical and proble...

Roles and Responsibility Develop high-quality medical writing content for various reports, including aggregate reports on pharmacovigilance. Conduct thorough research and analysis to ensure accuracy and completeness of written content. Collaborate with cross-functional teams to gather information and insights for report development. Create engaging and informative content that meets the needs of stakeholders and audiences. Edit and review content for clarity, grammar, and style. Stay up-to-date with industry trends and developments in pharmacovigilance and aggregate reporting. Job Requirements Minimum 2 years of experience in medical writing, preferably in the IT Service & Consulting industr...

Roles and Responsibility Develop and implement effective medical monitoring strategies for clinical trials. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct thorough reviews of medical data to identify trends and potential issues. Provide expert guidance on medical matters related to clinical development. Ensure timely reporting of adverse events and other safety concerns. Participate in quality control activities to maintain high standards of medical practice. Job Requirements Strong knowledge of clinical development principles and practices. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environ...

Roles and Responsibility Develop high-quality medical reports and documents for pharmaceutical companies. Conduct thorough research on various medical topics related to Pharmacovigilance. Collaborate with cross-functional teams to ensure timely delivery of projects. Analyze complex data sets to identify trends and patterns. Prepare presentations and visualizations to communicate findings to stakeholders. Stay updated with industry developments and regulatory requirements. Job Requirements Minimum 2 years of experience in medical writing, preferably in the IT Service & Consulting industry. Strong knowledge of Pharmacovigilance and Aggregate Reporting. Excellent writing and communication skill...