Clinical Regulatory Affairs Specialist Jobs in Bengaluru
196 Jobs Found
Senior Regulatory Affairs Specialist
Alivecor India
Senior Regulatory Affairs Specialist Location: Bangalore Company: AliveCor About AliveCor & The Opportunity AliveCor is a pioneer in **over-the-counter medical ECG devices**, dedicated to making heart health accessible. The company s **FDA-cleared medical-grade hardware and software** have enabled millions of heart health measurements, making a life-saving impact. We are seeking a **Senior Regulatory Affairs Specialist** to join our growing team. This is a critical role focused on **shaping regulatory strategy** for innovative mobile health technologies, managing product submissions, and ensuring compliance with international regulatory standards, including **ISO 13485 and FDA** Quality Systems. Role & Responsibilities As a Senior Regulatory Affairs Specialist, you will: Collaborate & Execute Regulatory Strategies: Work with product teams to **develop and execute global regulatory strategies** for registrations in the US, Europe, and other key regions. Manage Regulatory Submissions: Participate in the preparation and review of **global regulatory submissions**, including **510(k), de novo**, and other medical device filings. Support Government Interactions: Serve as the point of contact for regulatory agencies such as the **FDA, EU MDR**, and other international authorities, ensuring timely product approvals and licenses. Global Market Registrations: Drive product **registrations and renewals** for worldwide markets, supporting distributors with compliance documentation. Review & Approve Technical Documents: Assist in reviewing advertising, promotional materials, and technical documentation to ensure **compliance with applicable regulations**. ISO 13485 & FDA Compliance: Help implement and maintain an **ISO 13485 and FDA-compliant Quality Management System (QMS)**. Product Development Support: Collaborate with cross-functional teams (Engineering, Product, Quality) to support regulatory requirements during product development and design changes. Post-Market Compliance: Assist in post-market regulatory actions, including compliance with **reporting requirements and audits**. Requirements & Qualifications Experience & Education Experience: **4+ years in Regulatory Affairs within the medical device industry.** Education: Bachelor s degree in Science, Engineering, Math, or a medical field, or equivalent experience. Regulatory Experience with AI/ML: Experience in regulatory affairs for **software devices with AI/machine learning algorithms (SaMD)**. Core Regulatory Knowledge Global Regulatory Knowledge: Experience with **EU Medical Device Regulations (MDR)** and familiarity with regulatory processes in the US, EU, and Asia-Pacific regions. Regulatory Submissions: Experience preparing **510(k) submissions, pre-submissions, or de novo submissions** for medical devices. Skills Project Management: Ability to manage small projects with a focus on being organized, independent, and results-oriented. Analytical & Communication Skills: Excellent analytical, communication, and team collaboration skills, with a keen **attention to detail**. Preferred Qualifications Advanced Degree: Master s degree or regulatory affairs certifications such as **RAPS** (Regulatory Affairs Professionals Society). International Submissions: Experience in international submissions, especially in Asia-Pacific or LATAM regions. Perks & Benefits Working Model: Hybrid Working Model (Flexibility to work both remotely and in the office). Family Leave: Comprehensive Family Leave policies. Medical Benefits: Above-market family floater medical insurance, including coverage for parents/in-law parents. Office Perks: Complimentary lunch provided at the office and convenient metro connectivity. Qualification : Bachelors degree in Science, Engineering, Math, or a medical field, or equivalent experience
Associate - Inside Sales
Clinchoice
Associate Inside Sales Location: Bengaluru Employment Type: Full-Time About ClinChoice ClinChoice is a global leader in providing full-service clinical development and post-approval solutions to the world s top pharmaceutical, biotechnology, medical device, and consumer health companies. Since 1995, we ve partnered with innovators across the healthcare spectrum to accelerate clinical trials, ensure regulatory compliance, and advance patient safety. With operations spanning the U.S., U.K., Mexico, Armenia, China, Japan, India, and the Philippines, we deliver high-quality, data-driven solutions tailored to our clients unique needs. Position Summary We re seeking a motivated and detail-oriented Inside Sales Associate to join our growing team in Bengaluru. In this role, you will drive lead generation and business development initiatives by identifying new opportunities, reaching out to prospects, and supporting cross-functional collaboration to expand ClinChoice s footprint. Key Responsibilities Lead Generation & Outreach Research potential clients, including current and pipeline products, and identify key decision-makers. Initiate contact via targeted emails and cold calls to introduce ClinChoice s services and generate qualified leads. Consistently achieve monthly and quarterly goals for scheduling meetings with prospective clients. Maintain accurate records of all outreach activities, meetings, and follow-ups in the CRM system. Cross-Functional Collaboration Work closely with the Business Insights team to pinpoint opportunities and contribute to tailored marketing campaigns. Assist in distributing marketing assets to prospective clients and stakeholders. Market Intelligence & Learning Stay informed about ClinChoice s capabilities, offerings, and active projects. Build and maintain a robust knowledge base of client systems, industry trends, and market developments. Track changes in technology, operations, and regulatory landscapes to identify new sales opportunities. Additional Responsibilities Comply with all company policies, procedures, and data protection guidelines. Maintain strict confidentiality in all communications and documentation. Support broader organizational and departmental goals. Actively participate in training programs and ongoing learning initiatives. Candidate Profile Bachelor s degree in Commerce, Life Sciences, or a related field; MBA preferred. 0 2 years of relevant experience in sales, business development, or a similar role. Proficient in MS Office tools (Word, PowerPoint, Excel). Basic understanding of biostatistics is a plus. Strong analytical, communication, and interpersonal skills. Self-motivated, proactive, and able to work independently with a solution-oriented mindset. Be part of a globally recognized organization at the forefront of clinical innovation. Collaborate with cross-functional experts from around the world. Grow your career in a fast-paced, learning-oriented environment. Qualification : Bachelors degree in Commerce, Life Sciences, or a related field; MBA preferred
Medical Review Physician 1
Clinchoice
Medical Review Physician 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a detail-oriented and experienced Medical Review Physician to join our pharmacovigilance team in Bangalore. In this role, you will be responsible for the medical evaluation of individual case safety reports (ICSRs) across multiple data sources and therapeutic areas, ensuring compliance with global regulatory standards and internal quality benchmarks. Key Responsibilities Medical Review & Safety Assessment Perform medical review of both serious and non-serious ICSRs, with a focus on seriousness, expectedness, causality, and narrative quality. Review ICSRs originating from multiple sources: spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials. Evaluate and verify the selection of adverse events from source documents, assign appropriate MedDRA codes, assess product labelling, and review narratives for accuracy and completeness. Support triage activities and determine seriousness and relatedness across assigned products. Product & Process Expertise Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas, including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases. Ensure timely completion of all medical review activities in line with regulatory timelines and service level agreements (SLAs). Contribute to process improvement initiatives, including implementation of quality control checks and feedback mechanisms. Collaboration & Training Provide expert medical guidance to case processors, data entry associates, and quality reviewers to address queries and discrepancies. Mentor and train team members in GVP concepts, case processing standards, and disease-specific medical knowledge. Collaborate with internal functional teams and client therapeutic groups to resolve case-related issues efficiently. Compliance & Quality Stay updated with ICH-GCP, GVP modules, 21 CFR, and other relevant regulatory guidelines. Deliver consistent, high-quality output while ensuring compliance with client-specific conventions and global safety standards. Take on additional tasks as assigned by the team lead/manager, adapting to shifting business priorities when necessary. Candidate Profile Education: MBBS or MD is required. Experience: 2 4 years of hands-on experience as a Medical Reviewer for ICSRs. Regulatory Knowledge: Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), 21 CFR, and other international regulatory requirements. Technical Skills: Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint). Soft Skills: Excellent analytical, communication, and mentoring skills; ability to work independently and as part of a cross-functional team. Be part of a high-impact team contributing to global drug safety. Collaborate across a wide range of therapeutic areas and product portfolios. Develop and grow within a supportive, knowledge-driven work environment. Engage in continuous learning and professional development in a critical area of healthcare. Qualification : MBBS or MD is required
Lead/associate Manager - Case Processing1
Clinchoice
Lead/Associate Manager Case Processing 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a dynamic and experienced Lead/Associate Manager Case Processing to join our Pharmacovigilance team in Bengaluru. This role requires deep domain knowledge, leadership capability, and hands-on experience in handling Individual Case Safety Reports (ICSRs) across various sources. The ideal candidate will be responsible for managing day-to-day operations, ensuring compliance with global regulatory requirements, and mentoring a team of case processors. Key Responsibilities Operational Oversight Oversee and ensure the timely processing of ICSRs in accordance with SLA/KPI metrics. Allocate tasks effectively across the team to meet project deliverables and workload requirements. Proactively monitor team performance and work closely with team members to resolve operational or domain-related challenges. Risk & Issue Management Identify, escalate, and mitigate risks related to deliverables, compliance, or resourcing. Serve as a point of contact for internal stakeholders and clients regarding operational queries or escalations. Team Leadership & Performance Management Conduct regular performance evaluations, provide constructive feedback, and support career development of team members. Guide and mentor the team and Subject Matter Experts (SMEs) in ICSR processes, compliance standards, and MedDRA coding. Support functional capability development within the team and leadership pipeline. Training & Quality Assurance Conduct process and project-specific training as needed to ensure team competence and readiness. Ensure adherence to quality standards by contributing to quality system documentation, SOPs, and procedural updates. Provide feedback and suggestions to strengthen client/internal workflows and ensure continuous improvement. Process Improvement & Strategic Contribution Suggest and implement process enhancements to improve efficiency, accuracy, and compliance. Contribute to the development of scalable and sustainable pharmacovigilance processes. Collaborate cross-functionally to support strategic goals and business growth initiatives. Required Experience & Knowledge In-depth understanding of ICH-GCP, GVP modules, 21 CFR, and relevant global regulatory requirements. Proven expertise in managing high-volume ICSR workloads, including serious, non-serious, and potentially serious reports. Experience processing ICSRs from diverse sources: spontaneous, literature, solicited, regulatory authorities, and clinical trials. Exposure to therapeutic areas such as rare diseases and oncology is highly desirable. Experience in literature screening and review would be an added advantage. Proficient in MS Office applications (Excel, Word, Outlook, PowerPoint). Candidate Profile Education: Master s degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements. Experience: 10 12 years of relevant experience in pharmacovigilance, case processing, or related functions. Strong leadership skills with a proven ability to train, mentor, and manage cross-functional teams. Demonstrated ability to allocate resources, manage competing priorities, and maintain high-quality standards. Proactive, process-driven mindset with a commitment to continuous improvement and regulatory compliance. Work with a global leader in drug safety and pharmacovigilance services. Lead high-performing teams and contribute to the delivery of impactful healthcare solutions. Be part of a collaborative environment that values innovation, learning, and operational excellence. Apply now to lead meaningful work that impacts patient safety around the world. Qualification : Masters degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements
Quality Assessors
5c Network Pvt. Ltd.
Position: Quality Assessors (Radiology) Location: Bangalore, Karnataka, India Type: Full-Time Experience Required: 2 8 years Qualifications: B.Sc. in Radiology or Imaging Technology Job Summary: We are seeking dedicated and detail-oriented Quality Assessors / Radiographers to join our dynamic team. This is a unique opportunity to be part of a rapidly evolving healthcare ecosystem, working alongside leading radiologists and AI experts to transform diagnostic care through technology. Recent graduates or professionals with a B.Sc. in Radiology or Imaging Technology Candidates passionate about quality in healthcare and looking to grow within a technology-driven environment Key Responsibilities: Perform quality assessments of medical imaging studies to ensure accuracy and diagnostic value Collaborate with radiologists and AI engineers to support model validation and improvement Maintain documentation and compliance with clinical and regulatory standards Provide feedback on imaging quality and assist in continuous improvement initiatives What We Offer: Competitive Salary: Attractive compensation with additional benefits Professional Development: Ongoing training, mentorship, and skill-building opportunities Innovative Work Environment: Access to cutting-edge imaging and AI tools in a state-of-the-art facility Career Growth: Clear advancement pathways in a fast-growing healthcare AI organization Pioneers in AI Healthcare: Work at the forefront of artificial intelligence in radiology Commitment to Quality & Care: Make a meaningful impact on patient outcomes Tech-Enabled Innovation: Hands-on experience with the latest technologies and medical imaging systems Qualification : B.Sc. in Radiology or Imaging Technology
Data Science Specialist
5c Network Pvt. Ltd.
Position: Data Science Specialist Employment Type: Full-time Location: Bangalore, On-site Experience Required: 1 to 6 years (Mindset > Experience) About the Role: We re seeking a mission-driven, hands-on Data Analytics Specialist passionate about impact. This is not a typical analytics role you will drive key business metrics across clinical operations, stakeholder reporting, and automation. Collaborate closely with leadership, radiologists, operations, product teams, and AI engineers to ensure every decision is data-driven, actionable, and scalable. If you thrive on building dashboards, automating processes, streamlining pipelines, and driving growth through insights, this is your playground. Key Responsibilities: Own Business KPIs: Take full ownership of company-wide metrics, ensuring their accuracy, relevance, and actionability through stakeholder alignment. Data Engineering: Build and optimize ETL/ELT pipelines integrating data from Postgres, ClickHouse, and other sources. Dashboards & Reporting: Design and maintain intuitive dashboards (Metabase, Power BI, Tableau, Google Data Studio) that stakeholders actively use. Backend Data Transformation: Write clean, reusable code to convert raw data into actionable insights. API Development: Build and maintain internal APIs to serve analytics data to frontend and production systems. Email Automation: Develop real-time and scheduled email reports delivering dynamic insights to stakeholders. Spreadsheet Expertise: Automate and manipulate complex data in Excel/Google Sheets for detailed analysis and reporting. AI & Automation: Collaborate with AI teams to integrate predictive algorithms and automate analytics workflows. Business Acumen: Develop deep understanding of the teleradiology ecosystem clinical workflows, operations, financials, and tech platforms. Proactive Collaboration: Identify data gaps, flag inconsistencies, recommend improvements, and work closely with leadership. Required Skills: Strong Python skills for data analytics (Pandas, NumPy, FastAPI, Jupyter, etc.) Proficient in SQL (ClickHouse, PostgreSQL) with experience optimizing queries End-to-end dashboard ownership from data modeling to UI presentation Experience building or integrating APIs for analytics Advanced spreadsheet skills and formula-driven reporting Experience working with AI/ML models in applied settings (preferred) Hands-on backend data transformations, version control, and automation Familiarity with full-stack development frameworks (bonus) Bonus / Nice to Have: Exposure to dbt, Airflow, ChromaDB, Streamlit, Plotly Knowledge of data privacy, compliance, and healthcare analytics Experience building analytics platforms for SaaS or health-tech companies Mindset We re Looking For: 10x Hustler: Ready to learn fast and go the extra mile to solve problems. Obsessed with Accuracy: Data must be flawless before release. Extreme Ownership: Proactive in driving results without waiting for instructions. Fast Learner: Able to pick up new tools and concepts quickly. Business First, Code Later: Focused on impact, not just coding. Be part of India s fastest-growing teleradiology platform Direct access to leadership and real-world business impact Build game-changing analytics systems and influence strategy Gain exposure to AI, automation, product, and operations in one role Clear ramp-up roadmap and growth plan Expectations in First 3 Months: Build an end-to-end dashboard from scratch Clean up at least one messy data pipeline Automate a stakeholder email update Validate accuracy across critical business metrics Understand full-stack platform structure and propose an improvement
Data Privacy Compliance Specialist
Rubrik
Data Privacy Compliance Specialist Location: Bangalore, India Office About the Team Rubrik s Legal Team is at the heart of our mission to secure the world s data. We provide essential guidance across contract management, intellectual property, employment law, privacy, trade compliance, and litigation. Our team thrives on open debate, innovation, and ownership, contributing to building an iconic company. Rubrik is growing rapidly and evolving join us to be unstoppable, together. About the Role Rubrik is looking for a Data Privacy Compliance Specialist to strengthen and manage our global privacy program. The ideal candidate will have hands-on experience with privacy management accountability frameworks (PMAF), compliance auditing, and implementing data protection practices aligned with evolving global regulations. This role requires working collaboratively across procurement, engineering, product management, legal, and information security teams worldwide to maintain compliance and mitigate privacy risks. What You ll Do Conduct internal and coordinate external privacy audits as needed. Assess and monitor privacy compliance of third-party vendors and service providers. Continuously review data handling practices to ensure compliance with internal policies and global regulations. Develop, maintain, and enforce data privacy policies and procedures aligned with legal requirements and business objectives. Maintain detailed documentation to demonstrate compliance and accountability. Manage and update an inventory of personal data processing activities, including data flows and classifications. Oversee cross-border data transfer mechanisms ensuring adherence to applicable privacy laws. Lead internal privacy reviews, supporting engineering and data governance teams with data mapping, documentation, and privacy impact assessments. Collaborate with teams to implement privacy risk mitigation solutions while ensuring regulatory adherence. Develop and deliver privacy training to internal stakeholders to raise awareness and ensure compliance with privacy responsibilities. Experience You ll Need Minimum 3+ years of experience in data privacy compliance, preferably with exposure to Privacy Management Accountability Frameworks (PMAF). Strong knowledge of global data protection regulations such as GDPR, CCPA, CPRA, and relevant industry standards. Proven expertise in data mapping, risk assessments, and conducting privacy audits. Excellent communication and stakeholder engagement skills across diverse teams. Certifications such as CIPP-E, CIPM, CIPT, CISSP preferred; Juris Doctor (JD) is a plus. Skills Required Deep understanding of IT, SaaS, and cloud provider compliance challenges. Solid knowledge of information security principles and best practices. Proficiency with privacy management tools like OneTrust for data mapping and assessment automation. Basic understanding of cookies and marketing technology systems. Ability to clearly articulate complex privacy and security concepts to both technical and non-technical audiences. Join Us in Securing the World's Data Rubrik (NYSE: RBRK) is on a mission to secure the world s data with Zero Trust Data Security . Our platform leverages machine learning to secure enterprise, cloud, and SaaS data, helping organizations ensure data integrity, availability, risk monitoring, and rapid recovery from cyberattacks and operational disruptions.
Operations Finance Specialist
Shopup
Operations Finance Specialist Location: Bengaluru, India Company: ShopUp HQ Role Overview We are looking for a detail-oriented and analytical Operations Finance Specialist to support our business operations with robust financial planning, analysis, and cost control. You will work closely with operations, procurement, and senior management teams to drive financial efficiency, ensure accuracy, and enable strategic decision-making. Key Responsibilities Data Collection & Validation: Gather financial data from various business and cross-functional teams. Validate data related to Sales, COGS, Damages, Non-claimable items, Incentives, VAT, AIT, etc. Review and ensure accuracy of financial entries in NetSuite. Post journal entries and oversee approval workflows within financial systems. Audit & Compliance: Manage external audits and prepare audited Financial Statements in compliance with IFRS. Perform intercompany balance reconciliations and VAT input/output reconciliations. Ensure compliance with internal financial policies and regulatory requirements. Financial Reporting & Analysis: Prepare MIS reports including weekly, monthly, and yearly flash reports broken down by Subsidiary, Category, Business Unit, and Entity. Conduct entity-wise ICRRS and trend/variance analysis. Reconcile data between DMS and NetSuite. Match MIS reports with audited Financial Statements per IFRS. Monitor operational costs and analyze variances across departments. Support budgeting, forecasting, and strategic financial planning. Cost Control & Collaboration: Assist in implementing cost-control measures to improve financial efficiency. Collaborate with procurement and factory teams to ensure financial accuracy throughout the supply chain. Perform inventory and production cost analysis to support operational decision-making. Additional Duties: Assist in audits and ensure operational finance record accuracy. Identify financial risks and suggest mitigation strategies. Provide ad-hoc financial support and analysis to management as needed. Qualifications & Experience Educational Requirements: Chartered Accountant (CA), ACCA, or equivalent qualification highly preferred. Bachelor s or Master s degree in Accounting, Finance, or related field. Professional Experience: 2 4 years of experience in operations finance, cost accounting, or related financial roles. Skills & Competencies: Strong analytical, problem-solving, and data validation skills. Proficiency in Excel and financial ERP systems (NetSuite preferred). Good communication and cross-team collaboration abilities. Ability to work effectively in a fast-paced, detail-oriented environment. Qualification : Bachelors or Masters degree in Accounting, Finance, or related field.
Investigator Payments Analyst
Iqvia
Investigator Payments Analyst Location: Bengaluru Job Overview: The Investigator Payments Analyst is responsible for supporting the delivery of all required start-up contracting activities for selected sponsors, studies, or multi-protocol programs. This includes pre-award activities and providing essential operational and financial contracting support. The role ensures compliance with sponsor requirements, regulatory guidelines, and project timelines. Essential Functions: Grant Estimates & Proposal Support: Develop simple investigator grant estimates and proposal text to support the proposal development process. Contracting Tools & Systems: Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, ensuring alignment with the Scope of Work and Project Plan. Collaboration & Communication: Coordinate with sponsors, stakeholders, and RSU regions to ensure successful delivery of projects in compliance with sponsor requirements and the RSU Management Plan. Operational & Financial Support: Provide operational and financial contracting support to facilitate business development and efficient initiation and maintenance of clinical trials, ensuring compliance with regulatory requirements. Documentation Support: Assist in creating and reviewing scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance. Contracting Intelligence: Contribute to the collection, interpretation, analysis, and dissemination of contracting intelligence for assigned studies and the company. Efficiency & Reporting: Ensure contracting efficiency and adherence to project timelines and financial goals, and report on performance metrics and out-of-scope activities. Compliance & Quality Standards: Ensure compliance with contract management and quality standards, providing administrative and operational support to investigators and managers as required. System & Database Management: Accurately complete and maintain internal systems (including CTMS), databases, tracking tools, timelines, and project plans. Qualifications: Education: Bachelor's degree required. Experience: At least 1 year of relevant experience, including demonstrable experience as a contract negotiator or equivalent combination of education, training, and experience. Skills & Knowledge: Negotiation & Communication: Strong negotiation and communication skills to facilitate contract discussions and maintain professional relationships with sponsors. Interpersonal Skills: Ability to work effectively in teams and with internal and external stakeholders. Technical Writing: Strong technical writing skills for creating and reviewing proposals and documentation. Clinical Trial Knowledge: Understanding of clinical trial environments and the drug development process. Regulatory Knowledge: Knowledge of GCP/ICH guidelines, applicable regulatory requirements, and SOPs. Organizational Skills: Excellent organizational and planning skills for managing contracting activities. Software Proficiency: Strong knowledge of Microsoft Office and other relevant software tools. Contract Management: Good understanding of clinical trial contract management, including pricing models, proposals, and budgets. Additional Skills: Ability to interpret pricing models, prepare proposals, bid grids, and budgets. Ability to work in a matrix team environment and build effective working relationships with sponsors, co-workers, and managers. Ability to exercise independent judgment when negotiating contracts and making decisions. This role offers an exciting opportunity for individuals who have a strong foundation in contract negotiation and management, along with an understanding of the clinical trial landscape. If you are a detail-oriented, proactive individual with a passion for working in the healthcare and clinical trial industries, we encourage you to apply. Qualification : Bachelor's degree required.
Grc Specialist
Locus
Job Title: GRC Specialist Location: Bangalore (On-site; full-time) About Locus: At Locus, we are redefining logistics decision-making with deep-tech solutions that drive efficiency, consistency, and transparency across industries like retail and FMCG/CPG. Founded in 2015 by Nishith Rastogi and Geet Garg, Locus has evolved from a women s safety geo-tracking app into a globally recognized logistics optimization platform. Our technology has empowered enterprises such as Unilever and Nestl to execute over a billion deliveries across 30+ countries. Guided by our commitment to innovation and sustainable growth, we transform complex supply chains into strategic growth enablers. Join us at Locus and be part of a team shaping the future of global logistics. Job Overview: About the Role Governance Risk and Compliance Specialist (GRC Specialist) We're looking for a candidate with 2-4 years of relevant experience. Key Responsibilities: Define, implement, and maintain the Information Security Management System (ISMS) and Privacy Information Management System (PIMS). Plan and execute periodic risk assessments. Work directly with the business units to facilitate risk assessment and risk management processes. Define, Review and Maintain the organizational information security policies, processes, procedures and control framework to ensure it is adequate to address the emerging risks due to changing environment, technology and legal requirements. Align customer and internal information security objectives to the ISMS and PIMS. Monitor and fulfill client contractual (MSA) information security and privacy obligations. Monitor and fulfill legal obligations related to protection of personal information across different jurisdictions like GDPR, CCPA. Prepare metrics based periodic reports and dashboards with support from the stakeholder functions for management review. Liaise with security vendors, suppliers, service providers and external resources for new security tools for improving security. Lead the Information Security audits / assessments / remediation and present key risks to the management. Perform the Third party Risk Assessment of Critical Vendors. Conduct Information Security and Privacy awareness and training programs for the employees as part of their induction and regular awareness. Oversee information security and privacy incident management process for incident reporting, containment, resolution and root cause analysis. Plan and coordinate BCP and DR tests. Setup guidelines for secure coding practices. Recommend security and privacy controls based on people, process and technology approach and industry best practices. Identifying solutions or writing automation scripts for solving regular tasks or optimizing processes. SOC Monitoring Activities such as. Firewall, Vulnerability, Inspector, Guarduty etc. Log Review, Incident Handling & Compliance adherence. Qualifications: Good understanding of information security compliance requirements like ISO27001, SOC2, CSA STAR and Privacy requirements like BS10012 & ISO27701. Good understanding of legal obligations towards protection of personal information across different jurisdictions like GDPR, CCPA, etc. Experience in creating and auditing security and privacy best practices and implementation of security and privacy principles across organization, to meet business goals along with customer and regulatory requirements. Experience implementing security and privacy controls for cloud platforms like AWS, Azure. Experienced in solving Audit and Regulatory Issues. Experience in auditing MDM, SSO solutions, AWS (Cloud Infra), Firewall, WAF, DLP etc. Good at solving information security compliance challenges by recommending solutions and best practices. Join Locus and become part of a visionary team that is redefining logistics through innovation and smart distribution. We provide competitive compensation, comprehensive benefits, and a collaborative environment where your expertise will drive both your growth and that of the organization. Locus is an equal opportunity employer dedicated to creating a diverse and inclusive workplace.
Rwd Data Scientist
Johnson & Johnson Services, Inc
Description Johnson & Johnson is currently seeking a RWD Data Scientist, to join our Data Science and Digital Health function Innovative Medicine Research & Development located in Hyderabad/ Bangalore, India. Remote work may be considered case-by-case and if approved by the Company. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . The RWD Data Scientist, will work with real world data sets to identify cohorts using complex queries in order to inform site identification strategies, diversity planning, patient journeys and protocol optimization. Working with the Director, Global Data Science, Portfolio Management, you will use your deep RWD expertise and pharmaceutical industry knowledge to advance the use of real-world data to improve clinical trial productivity and efficiency. Major responsibilities include building complex cohort queries in SQL against multiple differently formatted databases. Building sophisticated and informative visualizations for study teams including heat maps, Sankey diagrams, and other charts. Major responsibilities include cohort creation, site list and diversity analysis, building visualizations for patient journeys and localization, and process automation for cohort creation. Responsibilities: Act as a hands-on cohort builder with SQL queries against targeting differently formatted data sets. Creating and integrating site lists with information about physicians, practice sites, patient counts, diversity, and other metrics used in site selection. Supporting the creation of diversity plans. Creation of RWD study dashboards Build visualizations for cohort such as heat maps, Sankey diagrams. Participate in project teams and collaborate working closely with data science, and clinical study teams to optimize queries and create desired output. Qualifications Master s degree in a quantitative field such as computer science, epidemiology (preferred), computational biology, statistics, or a related discipline. At least 3 years of relevant experience in healthcare or life sciences industry is required At least 3 years of relevant hands-on data science experience in an R&D environment, commercial, medical affairs, scientific affairs and/or is required Familiarity with medical coding (ICD-10, LOINC, SNOMED, NDC, etc.)_ Familiarity with large datasets, understanding of data analysis workflows, and/or knowledge of querying languages such as SQL is required. Handling of healthcare relevant datasets, such as EHR, insurance claims or registry data, is required. Proficient with one or more programming language such as Python (preferred), R, C++, or Java is required. Experience with visualization software/tools such as R, Spotfire, Tableau, etc. is preferred Strong problem-solving skills with a solution-oriented mindset Excellent communication, interpersonal, and written skills are required Qualification : Masters degree in a quantitative field such as computer science, epidemiology (preferred), computational biology, statistics, or a related discipline.
Statistical Programmer Ii
Icon Plc.
About ICON: ICON is a world leader in healthcare intelligence and clinical research. We are at the forefront of advancing clinical research, providing essential outsourced services to the pharmaceutical, biotechnology, and medical device industries. ICON s success is driven by the dedication and expertise of its people, who share a commitment to improving the lives of patients. Role Overview: As a Jr. Statistical Programmer, you will contribute to clinical research by performing programming tasks related to statistical analysis. You will be responsible for ensuring timely completion of programming activities, maintaining compliance with industry standards, and assisting with the development of clinical trial data. This role is ideal for someone with 3+ years of SAS Programming and R experience, looking to grow in the clinical research field. Key Responsibilities: Programming and Analysis: Develop an understanding of applicable policies, procedures, and industry standards. Complete programming tasks under supervision, ensuring accuracy and timely completion. Demonstrate programming expertise with a focus on SAS and R, assisting with statistical analysis tasks. Identify gaps in current programming practices and propose improvements. Adhere to industry standards, and stay updated with evolving best practices and regulations. Team Collaboration: Work effectively as part of a team, contributing to the success of clinical studies. Take responsibility for your assigned tasks, ensuring they are completed on time and in alignment with the team s goals. Required Qualifications: 3+ years of experience in SAS Programming and R. Strong programming and domain expertise in statistical programming. Ability to execute a wide range of programming activities with minimal supervision. Awareness of evolving industry standards and the ability to suggest improvements to existing practices. Benefits of Working at ICON: Competitive salary with variable pay and recognition programs. Comprehensive benefits package, including health insurance and retirement planning. Work-life balance initiatives, including flexible working hours and additional country-specific benefits such as childcare vouchers, gym memberships, and health assessments. Access to Global Employee Assistance Programme (TELUS Health), offering 24-hour support from a global network of specialists. Life assurance and other family-focused benefits. Why Choose ICON? ICON is committed to building a diverse and inclusive culture where talent is nurtured and rewarded. Our success depends on the collective strength of our people, and we offer ample opportunities for growth and career development. If you are passionate about making a difference in clinical research and want to work in a dynamic, supportive environment, we encourage you to apply. Qualification : 3+ years of experience in SAS Programming and R.
Sr. Regulatory Technical Program Manager
Ericsson-worldwide
We are excited to announce an opportunity for a talented individual to join Ericsson as a Technology Specialist. This unique role offers the chance to provide technology leadership in sectors that are of strategic importance to our company. You will be instrumental in the development of innovative solutions, components, and products using cutting-edge technology. As a Technology Specialist, you will significantly contribute to the strategic planning to ensure the competitiveness of our product portfolio. This role requires a global nomination and appointment, with further details available . What you will do: - Drive technology leadership, becoming an in-house spokesperson and advisor to senior management. - Contribute to strategic planning and ensure a competitive product portfolio through technical investigations and task force contributions. - Align technology strategies with product and development goals, influencing Ericsson s research activities. - Judge and introduce new technology advances when they become mature and cost-efficient. - Provide in-depth technical solutions for complex problems and drive the innovation process. - Represent the company in relations with customers and educational institutions, and uphold our position as a technology leader. The skills you bring: Qualification: Bachelor's degree in Electrical / Wireless Communication Engineering. Minimum 8 years of experience in project management within a regulatory environment with specialized knowledge in wireless communication technologies, including Bluetooth, Wi-Fi, and GSM (4G and 5G). Strong knowledge of Wireless global regulatory requirements and experience with regulatory submissions. Excellent organizational, analytical, and problem-solving skills. Excellent written and verbal communication skills, including the ability to interact effectively with global functional teams. Outstanding teamwork and collaboration skills. Proficiency in Microsoft Office 365. Qualification : Bachelor's degree in Electrical / Wireless Communication Engineering.
Senior Regulatory Specialist
Philips
Job Description Job title: Senior Regulatory Specialist Your role: The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW. Author 510k submissions, led pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications and lead interactions with regulators/competent authorities throughout review and approval process. Participate in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development. Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and project team. Able to manage special projects across spectrum of product lines. Monitor global regulatory landscapes and guide cross-functional team on implementation of regulation changes. Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements. Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory subject matter expert. Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements. Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead or participate on process improvement teams to affect changes at a local or cross business unit level. Opportunity for mentoring and coaching other regulatory team members and provide regulatory guidance. You're the right fit if: Minimum of 7-10 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience 510(k) experience is preferred. Preferred candidate will have a master s degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience. Will consider applicants Bachelors Degree with demonstrated experience working within Medical Device industry. Mastery in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations. Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentations and global registrations Strong written, oral, and interpersonal skills required to work in a team environment as well as individual contributor with minimal supervision. Solution and detail oriented, well organized and self-motivated with ability to negotiate with regulators. May require up to 20% travel How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Qualification : Preferred candidate will have a masters degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience.
Control Testing Specialist
Cargill
Job Purpose and Impact The Controls Testing Specialist will lead and execute testing engagements of IT controls within different technology control domains. In this role, you will consult with business relationship managers, project managers and other key stakeholders to ensure a coordinated approach to monitoring effectiveness of control design and implementation across the organization. Key Accountabilities Participate in the development and execution of assurance processes to ensure appropriate process, procedures and controls are adequately designed, implemented or remediated to meet compliance expectations, efficiency, sustainability goals and business objectives. Test the design and operational effectiveness of existing controls and recommend improvements to align with evolving regulatory and business needs. Write reports with identified findings and provide recommendations. Perform testing engagements including closure within the planned timelines. Consult, validate and monitor the implementation of remediation activities as result of testing findings and other identifications of non-compliance. Collaborate with risk analysts across all areas of the business on common risks to achieve optimization and coordination of remediation activities. Maintain and manage assurance documentation and records. Independently solve moderately complex issues with minimal supervision, while escalating more complex issues to appropriate staff. Qualifications MINIMUM QUALIFICATION Bachelor s degree in IT or CA with IT audit experience. Professional certifications such as CISA, CRISC will be a plus. Strong knowledge of regulatory requirements and compliance standards, such as COSO - SOX, SWIFT, NIST, ISO, COBIT and CIS Knowledge and understanding of Technical Security controls at Network, Server and Application layers Excellent report writing and presentation skills PREFERRED PRIOR EXPERIENCES 5+ years of experience in Audits or Controls Testing or Risk assessment services of IT infrastructure, Applications, IT processes, Business Continuity and Governance. Experience in the implementation of risk remediation activities internally and for external stakeholders Hands-on experience in Test of design controls and Test of operating effectiveness review of IT operational controls. Ability to ensure compliance with risk and security or regulatory policies, standards, procedures and guidelines. Ability to define issues, collect data, establish facts and draw valid conclusions. Respond to and assist with consultation for low complexity risk and security matters. Qualification : Bachelors degree in IT or CA with IT audit experience. Professional certifications such as CISA, CRISC will be a plus.
Director Process Management - Global Clinical Organization
Glaxosmithkline Plc
Job Purpose: The Director Process Management will be accountable for overseeing and optimizing assigned end-to-end business processes within Global Clinical Operations (GCO) to drive efficiency, compliance, standardization, and continuous improvement across the organization. They will lead and work collaboratively with cross-functional teams to identify areas for process improvement & innovation, implement best practices, control process health & compliance, and ensure processes align with GSK s strategic goals. Key Responsibilities: The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs. As the Global Process Owner for assigned processes lead the design, maintenance, and continuous improvement of these end-to-end processes. Ensure these processes comply with regulatory requirements, are aligned with GCO s strategies, consider innovative approaches being developed in the industry, drive efficiency, and are well defined. Ensure that written standards are developed and maintained as needed to support the process and that written standards can be clearly understood by end-users. Provide necessary information and training to help users understand and implement these processes effectively. Define and implement process oversight strategy with key performance indicators, in-process controls, management monitoring and end-user feedback. Establish benchmarks and conduct periodic review of performance metrics to ensure effectiveness, efficiency, and compliance. Report process health and compliance to the relevant stakeholders proactively and take appropriate measures where deficiencies are identified. Influence and engage with the organization by building a strong network with stakeholders, partners, and subject matter experts to understand their drivers and needs along with broader organizational goals. Use these insights to craft alignment, drive meaningful change and improve end-user experience. Define and manage process change roadmaps, aligning priorities with system updates and innovations to address evolving business needs, manage risks or interdependencies, and implement improvements at scale. Lead strategy, planning, execution, and implementation of process change projects, ensuring improvements are achieved through a combination of process-people-system solutions. Partner with subject matter experts and support roles to deliver a comprehensive solution package that includes the end-to-end process itself, written standards, training, communication, change management, implementation, and monitoring plans. Maintain current knowledge of global regulations and guidance, global regulatory expectations, regulation intelligence and industry standards pertaining to the assigned processes. Proactively assess impact of any new regulations on assigned process and ensure ongoing compliance. Proactively educate themselves in evolutions and innovations across the industry and evaluate how they could positively benefit the effectiveness, efficiency or compliance of the process. Develop and align proposals with the appropriate stakeholders to drive process innovation that is aligned with GCO s strategic priorities and stakeholder needs. Maintain personal readiness to respond to internal audits and regulatory inspections, be the point of contact and interact with inspectors, and provide expert advice to respond to audit observations. Represent GSK in external forums to influence the external ecosystem in shaping industry-leading practices and development of innovative methodologies Basic Qualifications Bachelor s degree in Scientific discipline. Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Operational Excellence, or a related field. Excellent understanding of clinical operations processes, and ICH/GCP and global regulatory guidelines for drug development and approval processes with specific expertise in informed consent, clinical trial supplies and distribution of clinical safety documents. Experience leading major projects to completion and driving cross-functional improvements. Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities. Forward-thinking and visionary mindset to modernize approach to clinical processes and leverage technology. Demonstrated matrix team leadership to deliver results. Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders, and broadly engaging with expert communities. Effective communication skills with ability to communicate and influence. Preferred Qualification Advanced degree in Scientific discipline Qualification : Bachelors degree in Scientific discipline.
Senior Statistician
Glaxosmithkline Plc
About GSK GSK is a global biopharma company with a shared purpose: to unite science, technology, and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by 2030 and deliver sustainable returns for our shareholders. At GSK, we focus on preventing diseases as well as treating them. Our success depends on our people, and we want GSK to be a place where individuals feel inspired, valued, and challenged to grow both professionally and personally. We offer a dynamic environment where employees can thrive, grow, and look after their wellbeing. Biostatistics Group (India) GSK's Biostatistics team in India is an integral part of the global Biostatistics function with a legacy of over 20 years. Our team, recognized for its strong leadership, talent, and high energy levels, plays a crucial role in therapeutically aligned, cross-functional, and global teams. We are seeking individuals at various levels, from new graduates to senior and managerial roles, who are passionate about innovation and technology and want to make a difference in patients lives. Role Overview As a Senior Statistician, you will play a pivotal role in the design, execution, analysis, and interpretation of clinical trials. You will have the opportunity to work with a broad range of statistical methodologies and collaborate with global teams to influence clinical development plans and strategies. The role involves working closely with internal and external partners to provide statistical input, ensuring the success of clinical studies. Basic Qualifications PhD in Statistics (with or without relevant experience) OR MSc in Statistics with more than 4 years of relevant experience in the design, execution, analysis, and interpretation of clinical trials. Expertise in a broad range of statistical methodologies, including: Experimental design Mixed models Bayesian methods Linear and nonlinear regression Excellent interpersonal and communication skills. Proven ability to build and maintain strong working relationships. Ability to explain novel and standard methods to both fellow statisticians and cross-functional teams. Strong influencing skills, applied effectively across all levels of the organization. Preferred Qualifications Experience in methodologies such as: Experimental design Mixed models Bayesian methods Linear and nonlinear regression Repeated measures Experience with modeling, simulation, and other innovative methodologies. Evidence of statistical innovation and technical expertise in clinical trials. Experience in regulatory submissions and interactions with regulatory bodies. Experience working with and coordinating Contract Research Organizations (CROs). Strong time management skills and the ability to manage multiple tasks across different projects. Key Responsibilities Provide statistical input to the design, analysis, reporting, and interpretation of clinical studies. Influence clinical development plans, regulatory, and commercial strategies. Build and maintain effective strategic relationships with internal and external partners. Develop and implement novel statistical methodologies to support medicines development. Stay updated with the latest developments in the field of statistics and explore their applicability within the organization. Manage conflicting demands and priorities while developing creative solutions to problems. At GSK, we are united in our responsibility to create healthier futures. If you are driven by a passion for science, innovation, and making a positive impact, GSK provides an exciting opportunity to grow your career while contributing to global health. Qualification : PhD (Statistics) with or without relevant experience (OR) MSc (Statistics) with >4 yrs relevant experience for Senior Statistician in the design, execution, analysis, and interpretation of clinical trials
Statistical Programming Associate Director
Astrazeneca
Job Title: Statistical Programming Associate Director Career Level - E Introduction to role The Statistical Programming Associate Director is accountable for the quality, timely, and efficient delivery of project programming work and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus. It will provide subject matter expertise within the Programming discipline. As an expert within their own field, you will act as a specialist within cross-functional teams to deliver continuous improvement. Accountabilities Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function Leads implementation of statistical programming aspects of the protocol or clinical development program Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverables and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contributes to cross-functional administrative or process improvement initiative(s) Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function Drives standards development and implementation Manages and escalates risk in complicated or novel situations within their study and/or projects Provides Programming expertise to the team Provides tactical input and/or drives ideas and improvements Contributes to the function by supporting recruiting and/or providing training and mentorship Identifies opportunities to improve methodology and provides practical solutions for problems Manages activities of our external partners (i.e., Contract Research Organisations) Influences stakeholders by providing subject matter expertise on programming-related items Ensures compliance with standards and automation usage Employs all project management practices in managing drug or technical projects Provides input to capacity management for all projects in scope Maintains expertise in the latest industry and regulatory requirements to stay current Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Proven programming expertise Thorough knowledge of the clinical development process Thorough knowledge of industry standards and ability to implement them Ability to apply programming expertise to problem-solving and troubleshooting for teams Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items Ability to manage risk in complicated or novel situations Project Mindset AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Qualification : Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent
Clinical Operations Assistant
Parexel
In this role the position will be based in India however will be working with teams in Japan and supporting the delivery of work in country. This would involve direct liaison with project teams, investigative sites and sponsors as might be required. All the communications would be expected to be done in Japanese and English- both written and verbal. Job Purpose: The role of the Clinical Operations Assistant (COA) is to maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality. Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case. Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact Harmony, as appropriate. COA is also to support all site management team members on local billable administrative tasks and assist with QC of Central files. Key Accountabilities: Track, scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan. Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP) Photocopy, print distribute and retrieval of documents, as needed Maintain basic quality check procedures to ensure accurate maintenance of documents Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only) Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery) Payment/invoice processing including internal follow up with payment specialists in Finance Courier shipment of study document to the sites, vender and clients Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within PAREXEL Skills: N2, N3 fluency in Japanese (reading, writing, and speaking) Sound problem solving skills. Experience working in CROs or Life Sciences industry preferred. Support with document collection, customization, review for clinical trials being conducted in Japan. Liaise with sites & investigators on assigned projects to facilitate conduct and delivery. Work closely with project management teams on all assigned tasks. Ensure quality and compliance in all clinical research activities. Ability to interact professionally within a client organization. Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise. Strong interpersonal, verbal, and written communication skills. Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables. Effective time management in order to meet study needs, team objectives, and department goals. Knowledge and Experience: Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology Education: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience N2, N3 fluency in Japanese (reading, writing, and speaking) Qualification : Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Key Opinion Leader (kol) Management
Dozee
Manager - Key Opinion Leader (KOL) Management Location: Bengaluru Department: Operations Clinical Engagement Employment Type: Full-Time About Dozee Dozee Health AI is India s leading provider of AI-powered, contactless Remote Patient Monitoring (RPM) and Early Warning Systems (EWS). Our mission is to save lives through connected healthcare, providing real-time monitoring that enables early detection of clinical deterioration, improves patient safety, and enhances outcomes. Trusted by hospitals across India, the USA, and Africa, Dozee is pioneering the future of patient care. Role Overview As a Manager - Key Opinion Leader (KOL) Management, you will play a crucial role in building strong relationships with healthcare professionals in partner hospitals. You will engage with senior doctors, medical directors, and department heads to communicate Dozee s research, clinical evidence, and product impact, helping them understand how our solutions can enhance patient safety and operational efficiency. Key Responsibilities Stakeholder Engagement Develop and nurture relationships with senior doctors, medical directors, and key decision-makers in partner hospitals. Conduct one-on-one meetings to understand their needs, address concerns, and provide tailored solutions. Act as the primary point of contact for KOLs, ensuring consistent and meaningful communication. Research & Product Advocacy Present Dozee s clinical evidence and product features to healthcare professionals in a clear, compelling manner. Showcase the impact of Dozee s solutions on patient safety and hospital efficiency. Gather feedback from KOLs to guide product improvements and share insights with internal teams. Relationship Management & Strategic Collaboration Serve as the key liaison between Dozee and the medical community, promoting trust and long-term partnerships. Collaborate with sales, marketing, and R&D teams to align KOL engagement strategies with business goals. Assist in co-creating evidence-based marketing materials and content with KOL input. Monitoring & Reporting Maintain detailed records of KOL interactions and monitor engagement progress. Prepare regular reports on KOL activities, feedback, and impact on business outcomes. Requirements Experience & Qualifications Bachelor s or Master s degree in life sciences, healthcare, or a related field. 5+ years of experience in a Senior Medical Representative or similar role. Expertise in engaging with doctors on research findings and medical trial data. In-depth understanding of the healthcare ecosystem and hospital operations. Skills Strong interpersonal and presentation skills with the ability to effectively communicate complex clinical data. Confident, persuasive, and comfortable interacting with senior healthcare professionals. Ability to travel extensively (up to 15+ days per month). Why Join Dozee Be part of an innovative, mission-driven company transforming healthcare with AI. Engage with top healthcare professionals and influence product adoption in leading hospitals. Contribute to a company that has already impacted 1 million+ patients and saved over 10 million nursing hours. Qualification : Bachelors or Masters degree in life sciences, healthcare or a related field
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