43 Redaction Jobs - Page 2

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Essential Functions Indepentendly performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Client’s disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills And Abilities Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency. Educational Requirements Minimum of bachelor’s degree in related field (scientific field preferred). Experience Requirements Minimum of 2+ years of direct experience in disclosures and/or data transparency. CRO or Outsourcing experience preferred. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Show more Show less

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years’ experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5565 Position Summary: The Senior Regulatory Administrator (SRA) provides essential administration and operational support to the Regulatory Affairs department, overseeing the efficient management and maintenance of regulatory documents within the regulatory systems. This role is pivotal for ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The SRA supports the department by managing the organization of regulatory documents for submissions, , ensuring compliance with relevant guidelines and regulations. The SRA involves in optimizing processes, mentor team members, and collaborating across departments to enhance our regulatory operational Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Assist under the guidance of Regulatory Manager in auditing and reviewing regulatory submissions for accuracy, completeness, and adherence to submission standards. Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Assist with internal audits and inspections by preparing required regulatory documentation and facilitating communication between stakeholders. Mentor, train and supervise junior Regulatory Administrators by providing guidance and support. Resolve complex issues related to submission document upload, publishing and system functionality. Contribute to planning and process improvement to enhance regulatory operation. Collaborate with cross functional teams. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 3 years in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Advanced knowledge of CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Previous Knowledge compiling and publishing, including eCTD. Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Excellent communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team Proven ability to resolve complex technical issues efficiently. Significant knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5566 Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years’ experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Key Responsibilities: Develop and Fine-Tune LLMs (e.g., GPT-4, Claude, LLaMA, Mistral, Gemini) using instruction tuning, prompt engineering, chain-of-thought prompting, and fine-tuning techniques. Build RAG Pipelines: Implement Retrieval-Augmented Generation solutions leveraging embeddings, chunking strategies, and vector databases like FAISS, Pinecone, Weaviate, and Qdrant. Implement and Orchestrate Agents: Utilize frameworks like MCP, OpenAI Agent SDK, LangChain, LlamaIndex, Haystack, and DSPy to build dynamic multi-agent systems and serverless GenAI applications. Deploy Models at Scale: Manage model deployment using HuggingFace, Azure Web Apps, vLLM, and Ollama, including handling local models with GGUF, LoRA/QLoRA, PEFT, and Quantization methods. Integrate APIs: Seamlessly integrate with APIs from OpenAI, Anthropic, Cohere, Azure, and other GenAI providers. Ensure Security and Compliance: Implement guardrails, perform PII redaction, ensure secure deployments, and monitor model performance using advanced observability tools. Optimize and Monitor: Lead LLMOps practices focusing on performance monitoring, cost optimization, and model evaluation. Work with AWS Services: Hands-on usage of AWS Bedrock, SageMaker, S3, Lambda, API Gateway, IAM, CloudWatch, and serverless computing to deploy and manage scalable AI solutions. Contribute to Use Cases: Develop AI-driven solutions like AI copilots, enterprise search engines, summarizers, and intelligent function-calling systems. Cross-functional Collaboration: Work closely with product, data, and DevOps teams to deliver scalable and secure AI products. Required Skills and Experience: Deep knowledge of LLMs and foundational models (GPT-4, Claude, Mistral, LLaMA, Gemini). Strong expertise in Prompt Engineering, Chain-of-Thought reasoning, and Fine-Tuning methods. Proven experience building RAG pipelines and working with modern vector stores ( FAISS, Pinecone, Weaviate, Qdrant ). Hands-on proficiency in LangChain, LlamaIndex, Haystack, and DSPy frameworks. Model deployment skills using HuggingFace, vLLM, Ollama, and handling LoRA/QLoRA, PEFT, GGUF models. Practical experience with AWS serverless services: Lambda, S3, API Gateway, IAM, CloudWatch. Strong coding ability in Python or similar programming languages. Experience with MLOps/LLMOps for monitoring, evaluation, and cost management. Familiarity with security standards: guardrails, PII protection, secure API interactions. Use Case Delivery Experience: Proven record of delivering AI Copilots, Summarization engines, or Enterprise GenAI applications. Experience 6-8 years of experience in AI/ML roles, focusing on LLM agent development, data science workflows, and system deployment. Demonstrated experience in designing domain-specific AI systems and integrating structured/unstructured data into AI models. Proficiency in designing scalable solutions using LangChain and vector databases. Job Type: Full-time Pay: ₹2,000,000.00 - ₹3,000,000.00 per year Benefits: Health insurance Schedule: Monday to Friday Work Location: In person

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation"and other regulations Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations. Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements Provide vendor oversight to support data sharing and document redaction, as appropriate Provide CRO oversight to support document redaction Work with IT, as needed, to implement technology solutions related to clinical trial disclosure Manage and track redaction book-of-work; compile and report on volume and performance metrics Provide operational support to CT Results Managers, as required Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements" Communicate with internal and external stakeholders to improve on processes and manage unmet need" Train new staff and develops job aids, work instructions, and user guides, as needed" Specific Knowledge, Skills, Abilities: Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies " Familiarity and comfortability working with and discussing scientific data Project and stakeholder management experience "" Demonstrated ability to work independently and seek out support when needed"" Exceptional written and oral communication skills"" Strong organizational skills with the ability to multitask and prioritize Education/Experience/ Licenses/Certifications: MA/MS in scientific or medical field 2-3 years of transparency experience and 5 years relevant work experience in a scientific or medical field with BA/BS If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation"and other regulations Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations. Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements Provide vendor oversight to support data sharing and document redaction, as appropriate Provide CRO oversight to support document redaction Work with IT, as needed, to implement technology solutions related to clinical trial disclosure Manage and track redaction book-of-work; compile and report on volume and performance metrics Provide operational support to CT Results Managers, as required Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements" Communicate with internal and external stakeholders to improve on processes and manage unmet need" Train new staff and develops job aids, work instructions, and user guides, as needed" Specific Knowledge, Skills, Abilities Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies " Familiarity and comfortability working with and discussing scientific data Project and stakeholder management experience "" Demonstrated ability to work independently and seek out support when needed"" Exceptional written and oral communication skills"" Strong organizational skills with the ability to multitask and prioritize Education/Experience/ Licenses/Certifications MA/MS in scientific or medical field 2-3 years of transparency experience and 5 years relevant work experience in a scientific or medical field with BA/BS If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less

About Amgen Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. What You Will Do Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information Work closely with cross-functional stakeholders to define redaction strategy, lead review and approval, ensure submission readiness, and hand off for timely submission or posting Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Communicate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Support trend analysis and process improvement What We Expect Of You Master’s degree and 1 to 3 years of relevant experience OR Bachelor’s degree and 3 to 5 years of relevant experience OR Diploma and 7 to 9 years of relevant experience Minimum of 2 years experience in preparing regulatory documents for public disclosure Familiarity with clinical research and clinical regulatory documents Knowledge of clinical trial disclosure regulations, guidelines, and best practices Basic Qualifications: Experience understanding and interpreting data/information and its practical application Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through Ability to follow controlled processes Excellent spoken and written English Ability to negotiate and influence Project management skills, including ability to prioritize work in order to meet required deadlines Problem solving ability 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. Show more Show less

Contract Duration: 4 Months Location: PAN India (Remote/Hybrid based on project needs) Experience Required: Up to 8 Years Key Skills Mandatory: OpenText xECM for SAP, OpenText VIM, OpenText Content Server, OTDS, SAP ECC/SAP HANA Job Overview We are seeking an experienced OpenText xECM Consultant with deep expertise in installation, configuration, and administration of OpenText xECM for SAP and related solutions. The ideal candidate will have hands-on experience integrating OpenText with SAP modules and managing document lifecycle through Content Server and Archive Server. Responsibilities Install and configure xECM for SAP with OpenText Content Server, Archive Server, and OTDS Perform upgrades of OpenText xECM for SAP from version 20.x to 24.x Administer xECM solutions including live reports, web reports, scheduling, and export functionalities Develop categories and perform metadata extraction using OCC/Enterprise Scan Configure and manage Brava Viewer for content markup and redaction Integrate xECM with SAP ECC and SAP HANA environments Implement SSO using OTDS and manage SAP authorizations for OpenText Build role-based Smart UI interfaces for business users Maintain documentation and provide support with excellent communication and collaboration skills Required Experience Strong hands-on expertise in OpenText xECM for SAP (v20.x – 24.x) Content Server and Archive Server administration Familiarity with OT VIM, Brava Suite, OTDS, and SAP integration Good communication and stakeholder management skills Apply now to be part of a dynamic project delivering critical document management solutions for enterprise clients. Show more Show less

Contract Duration: 4 Months Location: PAN India (Remote/Hybrid based on project needs) Experience Required: Up to 8 Years Key Skills Mandatory: OpenText xECM for SAP, OpenText VIM, OpenText Content Server, OTDS, SAP ECC/SAP HANA Job Overview We are seeking an experienced OpenText xECM Consultant with deep expertise in installation, configuration, and administration of OpenText xECM for SAP and related solutions. The ideal candidate will have hands-on experience integrating OpenText with SAP modules and managing document lifecycle through Content Server and Archive Server. Responsibilities Install and configure xECM for SAP with OpenText Content Server, Archive Server, and OTDS Perform upgrades of OpenText xECM for SAP from version 20.x to 24.x Administer xECM solutions including live reports, web reports, scheduling, and export functionalities Develop categories and perform metadata extraction using OCC/Enterprise Scan Configure and manage Brava Viewer for content markup and redaction Integrate xECM with SAP ECC and SAP HANA environments Implement SSO using OTDS and manage SAP authorizations for OpenText Build role-based Smart UI interfaces for business users Maintain documentation and provide support with excellent communication and collaboration skills Required Experience Strong hands-on expertise in OpenText xECM for SAP (v20.x – 24.x) Content Server and Archive Server administration Familiarity with OT VIM, Brava Suite, OTDS, and SAP integration Good communication and stakeholder management skills Apply now to be part of a dynamic project delivering critical document management solutions for enterprise clients. Show more Show less

Job Description Analyst, Data Privacy Business and individuals which process personal data can be both liable if they fail to comply with GDPR and local data privacy regulations. The global data privacy team, which extends across France, UK, Germany, United States and India, helps put in place operational controls to manage this type of risk throughout the organization, as well as managing of the day-to-day compliance namely managing of Data subjects’ requests, follow-up of actions plans, carrying out of DPIA and up to date of Recording of Processing Activities. The global data privacy team works particularly closely with Operations and Business Units and senior business management which are accountable for ensuring that Personal Data processes & procedures meet local requirements and are consistent with the Data Privacy Policy and who are the first line of defense . What You’ll Be DOING What will your essential responsibilities include? Assist the AXA XL global data privacy team. Helping Global DP team manage important administrative, reporting and repetitive tasks across regions. Managing of Data Subjects Access Request (DSAR): search of the data subject/reference, acknowledgment of the request, investigation, analysis of the relationship, redacting files, validation of redaction, letter. Managing of Data breaches: investigation, follow-up, update of data incidents reports. Updating of Register of Processing Activities (ROPA). Updating of Data Privacy Impact Assessments (DPIA)'s status tracker and preparation of DPIA Committee and DPIA sign-off. Supporting CDPO by meeting to schedule, minutes, track the actions, triage mailbox and track in excel file. Watching process and follow up of any new regulation. Following-up of compliance actions plans. Actively participate in Global and local projects with DP team per requirements. Pick up adhoc DP tasks as delegated by the DPO’s from time to time. Help with overall administration of the Global DP program. You will report to Data Privacy Office Manager. What You Will BRING We’re looking for someone who has these abilities and skills: Required Skills And Abilities University Degree with minimum 50% aggregate, with Law as one of the subjects. Fluency in English (oral and drafting). Excellent analytical skills with an attention to detail. Working Knowledge of MS Excel and Powerpoint. Effective interpersonal skills with the ability to communicate with senior stakeholders and interact with business lines. Junior data privacy counsel with a relevant years of experience in Data protection preferred. Desired Skills And Abilities Legal background with specialization in NICTs, data preferred. Knowledge of Data Protection Regulation preferred. Experience in insurance industry preferred. Who WE are AXA XL, the P&C and specialty risk division of AXA, is known for solving complex risks. For mid-sized companies, multinationals and even some inspirational individuals we don’t just provide re/insurance, we reinvent it. How? By combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business − property, casualty, professional, financial lines and specialty. With an innovative and flexible approach to risk solutions, we partner with those who move the world forward. Learn more at axaxl.com What we OFFER Inclusion AXA XL is committed to equal employment opportunity and will consider applicants regardless of gender, sexual orientation, age, ethnicity and origins, marital status, religion, disability, or any other protected characteristic. At AXA XL, we know that an inclusive culture and enables business growth and is critical to our success. That’s why we have made a strategic commitment to attract, develop, advance and retain the most inclusive workforce possible, and create a culture where everyone can bring their full selves to work and reach their highest potential. It’s about helping one another — and our business — to move forward and succeed. Five Business Resource Groups focused on gender, LGBTQ+, ethnicity and origins, disability and inclusion with 20 Chapters around the globe. Robust support for Flexible Working Arrangements Enhanced family-friendly leave benefits Named to the Diversity Best Practices Index Signatory to the UK Women in Finance Charter Learn more at axaxl.com/about-us/inclusion-and-diversity. AXA XL is an Equal Opportunity Employer. Total Rewards AXA XL’s Reward program is designed to take care of what matters most to you, covering the full picture of your health, wellbeing, lifestyle and financial security. It provides competitive compensation and personalized, inclusive benefits that evolve as you do. We’re committed to rewarding your contribution for the long term, so you can be your best self today and look forward to the future with confidence. Sustainability At AXA XL, Sustainability is integral to our business strategy. In an ever-changing world, AXA XL protects what matters most for our clients and communities. We know that sustainability is at the root of a more resilient future. Our 2023-26 Sustainability strategy, called “Roots of resilience”, focuses on protecting natural ecosystems, addressing climate change, and embedding sustainable practices across our operations. Our Pillars Valuing nature: How we impact nature affects how nature impacts us. Resilient ecosystems - the foundation of a sustainable planet and society - are essential to our future. We’re committed to protecting and restoring nature - from mangrove forests to the bees in our backyard - by increasing biodiversity awareness and inspiring clients and colleagues to put nature at the heart of their plans. Addressing climate change: The effects of a changing climate are far-reaching and significant. Unpredictable weather, increasing temperatures, and rising sea levels cause both social inequalities and environmental disruption. We're building a net zero strategy, developing insurance products and services, and mobilizing to advance thought leadership and investment in societal-led solutions. Integrating ESG: All companies have a role to play in building a more resilient future. Incorporating ESG considerations into our internal processes and practices builds resilience from the roots of our business. We’re training our colleagues, engaging our external partners, and evolving our sustainability governance and reporting. AXA Hearts in Action: We have established volunteering and charitable giving programs to help colleagues support causes that matter most to them, known as AXA XL’s “Hearts in Action” programs. These include our Matching Gifts program, Volunteering Leave, and our annual volunteering day - the Global Day of Giving. For more information, please see axaxl.com/sustainability. Show more Show less

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Job Description The candidate must have strong troubleshooting skills on Database and Database technology products Expertise in Performance issue analysis and providing resolution Guide customer on Oracle Database Best practices Should possess knowledge on implementation and supporting on Database Security Products like Transparent Data Encryption, Redaction, Data Vault, Masking. Possess strong troubleshooting skills on Real Application Cluster Should be able to guide and mentor team of engineers on Database Technology products Should possess knowledge and be able to articulate to customer the use cases of Advanced Compression, In-memory Knowledge on Oracle Enterprise Manager Personal Skills Strong experience in service delivery and/or project management is required. Oracle products and services knowledge will be highly appreciated as well as experience in Oracle HW platforms and OS. Experience on Enterprise Customers is required Excellent communication / relationship building skills Customer focused and results oriented Ability to work under pressure in highly escalated situations Organized with strong attention to detail Decision making / problem solving skills Ability to manage multiple concurrent activities (customer engagements) Highly professional: Ability to deal with senior and exec stakeholders with confidence Strong analytic skills and ability to pre-empt potential risks and issues Career Level - IC4 Responsibilities RESPONSIBILITIES Be the single point of contact within Oracle for the customer, acting as their advocate for the service you are responsible for delivering. The CSS TAM is a customer advocate and must demonstrate customer obsession by placing the client needs first. Provide technical guidance and be part of the customer calls/meeting on adoption of database technology Should possess strong technical skills on Database and DB products to advocate to customer the use cases and guide the customer and team of Oracle CSS Engineers through the lifecycle of Oracle Technology product adoption Manage the contract or delivery engagement as defined by ACS line management, including creating and maintaining accurate documentation Maintain the Oracle business systems to ensure systems are up to date with the correct/current information (resource assignment, timecards, rates, completion estimates, invoice details etc.) to ensure that services are delivered efficiently, invoices are generated in a timely manner and revenues are recognised promptly. Plan and deploy resources to ensure effective delivery within agreed budgetary constraints. Where appropriate create and maintain the ACS service delivery or project plan. Actively manage project forecast, identify risks and issues and opportunity for revenue collection (upside) Accountabilities: Proactively manage the contract delivery to completion / customer acceptance Proactively report on any potential risks / issues that may impact service delivery or customer satisfaction Manage any customer escalation that may arise Ensure all contract-related systems and documentation either required contractually or as part of a program, are up to date and accurate Monitor and report revenue forecast and margin estimates, revenue and margin achievements for each contract Work in line with customer working practices and procedures, if contractually agreed Operate in line with Oracle CSS business processes and procedures Operate in line with Oracle Global and local HR policies and procedures About Us As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law. Show more Show less

Location - Navi Mumbai, India Job Purpose The John Cockerill Group, a world leader in Green Hydrogen technologies has established itself as a reliable partner for all the stakeholders aiming to achieve Net zero emission targets. We are present across geographies and in all key energy markets. Our mission is to accelerate the transition to green hydrogen for a carbon-neutral world. We are a recognized leader globally for large-scale decarbonized hydrogen production solutions. John Cockerill's offer ranges from the supply of equipment to the EPC turnkey solution for industry, the energy sector or mobility. To support the development of its Hydrogen Business Line, John Cockerill Hydrogen (JC H2) is looking for a Lead Instrumentation Engineer (m/f) to be based in India office engineering center. The Instrumentation Engineer is part of the EAI team, which includes people specialized in industrial electricity, power conversion, automation, and instrumentation. He/She will be responsible for all the design and engineering execution of instrumentation and basic electrical study of domestic and international FEED & Details engineering projects. Key Result Areas Based on process team studies, check and develop the P&ID's related to the solution. Write the specifications, participate in technical discussions with customer and suppliers. Identify future solution, based on market evolution. Identify improvements and/or weaknesses. Follow-up new technologies and suppliers’ development to ensure the best technical and economic solution for each of our products. Key Responsibilities The Instrumentation engineer will be responsible for: design of instrument in process installations, Specify instruments (technical specifications and/or datasheets), Develop the instrument list and IO list relative to a project ; Contact suppliers in collaboration with the Purchasing Department, to ensure the technical comparison of offers and technical discussions with suppliers. Determine the different scenarios based on process parameters. Deliver input for technical specifications after design optimization. Conducts risk analysis and HAZOP. Revise the parameters based on supplier feedback and internal detailed calculations. Assesses compliance with applicable safety and quality standards. Participate in the redaction of commissioning procedure. Ensure the follow-up of suppliers, including receipt of material. Participate to FAT and SAT related to it's studies, based on checklists for verification of product conformity Develop engineering process and templates for the team. Interested and ensure the technological watch, be proactive in the continuous learning of Hydrogen sector. Knowledge in electrical basic design is a key advantage. Be able to design and specify electrical philosophy. Realization of low-voltage electrical distribution studies. Carry out power balances, cable books and cable calculation notes. Realize single-line and multifilar diagrams. Develop layout diagrams for EAI equipment, cables and cables trays Produce project lists (electrical consumers, load list, cable list, bill of quantities, etc.) Education And Experience You have an engineering degree in I&C or in the electrical field, You have minimum 15 years' experience in process design and engineering in an industrial environment. Experience and knowledge in the Oil&Gas or Energy sector is an asset. Being proficient in process control, measurement principles, control valves, transmitters, analyzers, and other relevant instruments Knowledge of the following standards, on top of electrical ones (IEC, NEC): Functional Safety Electromagnetic Compatibility Explosive Atmosphere API You have a strong and autonomous personality, an entrepreneurial mindset and a will to win. You are able to prioritize and have an excellent sense of organization. You are able to work in a team and take responsibility on several projects in parallel. You are adaptable and at ease with evolving in a continuously growing environment. You are fluent in English and French You are proficient in MS office, Teams, and SharePoint Background, Skills, And Competencies I&C Engineer with design and engineering experience in oil & gas / Energy / Green Hydrogen sectors Minimum experience 15 years as I&C engineer with Leading and reputed Engineering / EPC companies operating in oil& gas, energy, renewable energy sectors. Exposure and experience of Green Hydrogen projects is a plus. Who We Are About John Cockerill John Cockerill is a global player in energy transition. With more than 200 years of experience in energy, industry and mobility, the company designs and integrates innovative technology to facilitate access to low-carbon energy. These technologies and associated expertise are dedicated to the production, storage, and distribution of electricity from renewable energy sources and to optimizing the efficiency of power plants. The technologies apply to steam-gas, hydraulic, hydrogen, solar, nuclear, wind and biomass energy. To complement its commitment to the fight against climate change, John Cockerill is also deploying solutions to contribute to greener mobility, to produce responsibly, to preserve natural resources and to fight against insecurity. In 2020 John Cockerill achieved a turnover of Euro 1.01 bn in 19 countries. John Cockerill, which is privately owned, employs 5,200 people worldwide, including more than 400 in India. Equal Opportunity Employer John Cockerill and all John Cockerill Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, ancestry, sex (including pregnancy, childbirth, and related medical conditions), age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity or expression, and other characteristics protected by law. Show more Show less

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor's degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years' experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor's degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years' experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Come work at a place where innovation and teamwork come together to support the most exciting missions in the world! Job Description: We are seeking a skilled Penetration Tester to assess and enhance the security of our cross-platform executable Qualys Cloud Agent. This agent is responsible for system monitoring, data collection, and secure communication with a cloud platform. Operating across Unix, Windows, and macOS environments, the agent plays a critical role in our security and compliance solutions. The ideal candidate will uncover vulnerabilities, simulate attack scenarios, and work with our teams to fortify the system against threats. Key Responsibilities: Cross-Platform Agent Testing: Conduct comprehensive security testing of the executable agent, ensuring robust functionality across Unix/Linux, Windows, and macOS platforms. Identify and exploit vulnerabilities in the agent’s runtime behavior, system interactions, and interprocess communications. Test agent privilege management and evaluate risks of escalation or exploitation. Data Collection and Handling: Analyze the agent’s data collection mechanisms to ensure data privacy and integrity. Validate proper implementation of sensitive data redaction and secure storage practices. Communication Security: Test the agent’s secure communication mechanisms with the cloud server, focusing on: Encryption (TLS/SSL, public key cryptography). Authentication and session management. Mitigation of threats like MITM, replay attacks, and DNS spoofing. Reverse Engineering and Exploitation: Perform binary analysis to identify vulnerabilities in the agent's implementation. Reverse engineer agent components to assess the effectiveness of tamper-proofing mechanisms and embedded security features. Simulate advanced threat scenarios, including code injection and runtime manipulation. System Security Evaluations: Assess the agent’s impact on host system security, ensuring it does not inadvertently introduce risks (e.g., open ports, exploitable configurations). Evaluate installation, update, and self-defense mechanisms for tamper resistance and exploitation risks. Reporting and Remediation: Provide detailed vulnerability reports with proof of concept (PoC), risk impact assessments, and actionable remediation steps. Collaborate with development team to address vulnerabilities and validate fixes Contribute to improving secure development practices and robust agent design. Required Qualifications: Technical Expertise: In-depth knowledge of penetration testing methodologies for executable agents, system processes, and OS-specific security models (Windows, Unix/Linux, macOS). Proficiency in network security and cryptographic protocol testing. Strong background in reverse engineering tools and techniques Tools & Scripting: Scripting skills in Python, Bash, PowerShell, for creating custom tests. Hands on experience with proxy solutions ex Burp or Fiddler Experience: Proven track record of assessing software agents or similar system monitoring tools. Familiarity with common vulnerabilities, including CVEs related to agent-based applications. Experience working with security tools or platforms similar to Qualys Agent. Certifications (Preferred): OSCP, OSWE, CEH, GPEN, or equivalent cybersecurity certifications. Relevant cloud certifications such as AWS Security Specialty, Azure Security Engineer Associate. Preferred Qualifications: Hands-on experience with agent technologies similar to Qualys Cloud Agent. Familiarity with cloud architecture, APIs, and integration points. Knowledge of secure coding practices and defensive programming. Experience with CI/CD pipeline security.

Job Summary:The Associate Project Manager of Client Services plays a crucial role in efficiently managing designated client relationships through expert project management coordination and execution. Candidates should possess 5-8 years of experience in project management or similar positions, with responsibilities including defining and overseeing project scope, timelines, and ensuring the effective delivery of eDiscovery Projects. Responsibilities:The Associate Project Manager will be responsible for:Maintaining proactive communication with clients consistently.Cultivating client relationships conducive to smooth communication and effective problem-solving.Initiating and/or leading kick-off calls or high-level design calls with clients, as well as preparing monthly forecasting and client cost estimates where necessary.Handling review platform-specific tasks, including but not limited to:User requestsDatabase management (archiving/deletion)Creating layouts/views/fields/choices/highlighting/transform setsCreating and executing STR’sCreating and managing batch setsCreating and executing production conflict searchesConsulting on redaction setsReportingProviding matter-specific support on items such as privilege log generation, media tracking, search term formatting and consultation, consultation on processing, production, and review workflow, and creation of standard operating procedures (SOPs).Addressing client issues or promptly escalating them to the Client Services Manager or Senior Project Manager when necessary.Delegating, mentoring, and coaching team members.Troubleshooting issues, recommending solutions, effectively implementing them, and documenting for internal and external stakeholders.Striving to achieve project and revenue utilization targets as outlined in the job profile.Maintaining accurate and up-to-date records regarding the status of all projects.Creating playbooks for all clients to standardize service delivery and promote repeat business.Participating in process improvement initiatives across the organization and collaborating with teammates to standardize and enhance the customer experience.Delegating tasks to team members through continuous training on project-related tasks such as processing and review workflow, productions, etc.Engaging in personal professional development within the department.Exemplifying company values to team members and throughout the department. Qualifications/requirements:Must have 5+years of experince into eDiscovery operations or Client Services.Hands-on experiences with Relativity tools.Must be comfortable working in US Business Hours (India Night Shift) Familiarity with litigation support/eDiscovery platforms for processing and review.Bachelor's degree in Law or Technology.Demonstrated success in managing multiple simultaneous projects with eDiscovery clients and meeting tight deadlines.Excellent oral and written communication skills reflecting a high-quality approach to legal service.Client relationship skills, including proactive management of client expectations, understanding client needs, and consistent adaptation to meet client requirements.Ability to learn quickly and adapt to changing industry trends.Willingness to work night shifts. It is Epiq’s policy to comply with all applicable equal employment opportunity laws by making all employment decisions without unlawful regard or consideration of any individual’s race, religion, ethnicity, color, sex, sexual orientation, gender identity or expressions, transgender status, sexual and other reproductive health decisions, marital status, age, national origin, genetic information, ancestry, citizenship, physical or mental disability, veteran or family status or any other basis protected by applicable national, federal, state, provincial or local law. Epiq’s policy prohibits unlawful discrimination based on any of these impermissible bases, as well as any bases or grounds protected by applicable law in each jurisdiction. In addition Epiq will take affirmative action for minorities, women, covered veterans and individuals with disabilities. If you need assistance or an accommodation during the application process because of a disability, it is available upon request. Epiq is pleased to provide such assistance and no applicant will be penalized as a result of such a request. Pursuant to relevant law, where applicable, Epiq will consider for employment qualified applicants with arrest and conviction records.