Clinical Trials Jobs in Mumbai

Job Description Job Title: Medical Advisor Job responsibilities: To actively contribute to the organization/business unit (BU)/TA cluster by taking responsibility for the scientific, technical and ethical soundness of all policies, statements and endeavors. To lead the BU medical team in all activities medically related to the allocated Pfizer Business Unit portfolio and provide high quality and timely service in the areas of medical initiatives/support to the assigned portfolio, Interactions with Healthcare Professionals, Continuing Medical Education, Clinical Research, Sales Force Training, Medical Information, and Performance/People Management, and support in the areas of New Product Development/ Branded Value Offerings, Regulatory Affairs, Quality Standards, and Business Technology A. Strategic/Policy: Provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed B. Operational: Medical Initiatives/support for the Allocated Portfolio (New/Key Detail/In-line Products) Provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines Initiate and/or review and/or approve promotional, training, and Continuing Medical Education (CME) material in compliance with relevant SOPs/regulations/industry codes/working practices Participate/facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, etc. C. Clinical Research : In consultation with concerned stakeholder/vendor/interface, develop/write and/or review and/or approve protocol synopsis/final protocols/supporting documents per need (e.g., investigators brochure (IB), informed consent form (ICF), patient information sheets, etc.) for, Phase IV, PMS, Observational studies / surveys, Pharmacoeconomic / Outcomes Research studies, and other clinical projects / programs. In consultation with concerned stakeholder/vendor/interface, review and approve additional supporting documents/databases including ICF/CRF/SAP, etc. Assist in planning, organizing and preparing Investigational New Drug Applications (NDAs) Review/interpret data generated; write final reports for locally sponsored studies as required Develop and execute Publication Plan; review/approve/write manuscripts for publication of locally sponsored studies Develop and execute Information Dissemination Plan/Program Medical Information Provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies D. Sales Force Training: Provide medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives Provide pre-launch and launch training to sales staff for new products E. New Product Planning/Development: For global products, assist NPP team with preparing business case, and pre-commercialization programs/initiatives/activities to prepare internal and external stakeholders for new product launches. These include assistance with market research, stakeholder mapping, and early access programs Support New Product Planning, Marketing, and Business Development colleagues with medical evaluation and recommendations on opportunities to launch new products (e.g., licensing, acquiring, co-promotion, etc.) Support organization efforts at developing local formulations/line extensions through literature search/recommendations. Function as custodian for coordinating internal and regional approvals through the RFD (Request For Development) process F. Regulatory: Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication. Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.) Write, revise, and review labeling documents for pipeline/local products per relevant SOPs Provide medical support towards processing of spontaneous/solicited AE reports, per relevant SOPs and/or working practices Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical

About the Role As a Senior CRA, you will join one of the world s largest and most comprehensive clinical research organizations. This role offers the opportunity to work alongside a world-leading pharmaceutical company focused on cutting-edge science in therapeutic areas such as cancer, cardio-metabolic diseases, vaccines, and oncology areas that make up 70% of their portfolio. This partnership spans 21 years and is dedicated to making a positive impact in these therapeutic areas, offering you a chance to contribute meaningfully to global health outcomes. Key Responsibilities Study Management: Perform all aspects of CRA duties including site selection, initiation, monitoring visits, and close-out visits through to database lock. Study Team Collaboration: Work closely with the client's study team while having a dedicated ICON line manager to provide continuous support. Site Oversight: Oversee all aspects of study site management, ensuring high-quality data and low query levels with robust Quality Assurance reports. What You ll Need Education: Degree in Pharmacy or related fields. Experience: 4+ years of prior monitoring experience in global trials, working within a Contract Research Organization (CRO) or pharmaceutical company. More than 2 years of global oncology study experience. Skills: Excellent written and verbal communication skills. Strong knowledge of international guidelines (ICH-GCP) and local regulations. Flexibility to travel and work from the sponsor's office during onboarding (around 3 days/week) if not traveling. What ICON Offers You ICON values the quality of its people and fosters a diverse and rewarding culture. Besides a competitive salary, ICON offers a range of additional benefits designed to promote well-being, work-life balance, and long-term financial security: Annual Leave: Various leave entitlements. Health Insurance: Tailored options for you and your family. Retirement Planning: Competitive offerings to ensure you can plan confidently for the future. Employee Assistance Programme: 24-hour access to over 80,000 professionals supporting well-being. Life Assurance: Financial security in the event of unforeseen circumstances. Additional Benefits: Options like childcare vouchers, gym discounts, health assessments, subsidized travel passes, and more (depending on your country). Qualification : Degree in Pharmacy or related fields.

Job Description Country Medical Director, India THE OPPORTUNITY The Country Medical Director (CMD) is the Senior Medical Leader for Our Company in a country and serves as the leader of the medical affairs organization in their geography Based in Mumbai, named one of the Best Companies for Women in India by Avatar, 2019. Join the premier biopharmaceutical company that has been in Asia Pacific for over 60 years We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio. WHAT YOU WILL DO: CMD is the primary country level contact for Medical Affairs (MA) and has the following key responsibilities: Develops and executes the MA strategy for the country Creates and maintains a high-performing, highly compliant MA organization for the country Manages the entire portfolio for Our Company allocates resources balancing global and local priorities Represents Medical Affairs in the Country Leadership Team and in cross-functional collaborations with other Research & Development functions, Human Health (HH), and others Communicates accomplishments, opportunities, and needs of the country/cluster to regional and/or global stakeholders Represents Our Company in external activities requiring the leadership and expertise of the country s Senior Medical Leader Responsibilities and Primary Activities: Leadership and Management of the Medical Affairs Organization People Proactively manages and develops talent Proactively identifies new opportunities and gaps vs. emerging needs and addresses in a timely manner by reallocating and training of existing staff and/or external recruitment Creates an empowering, compliant, collaborative, and innovation-focused work environment Builds a culture of quality and compliance through training, oversight, and collaboration Country Medical Affairs Plans (CMAPs) Strategically develops, executes, and delivers CMAPs, including tactical deliverables for each therapeutic area, such as post-licensure research, publication plans, investigator-initiated studies, and other knowledge transfer activities Ensures alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs) Manages the country-developed Protocol Concept Sheets (PCS), obtains regional and global approvals for new local data generation activities, and manages their execution Medical Affairs Management Provides oversight to the country medical information team, establishes processes and systems to ensure that medical information requests (MIRs) from healthcare professionals are addressed in a timely manner and in alignment with the global scientific response documents and training materials Manages approved operating administrative (e.g., salaries & travel) and life cycle management budget (e.g., advisory boards, local data generation, etc.) Oversees all activities of local medical department employees Oversees inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, Pharmacovigilance (PV) and Global Clinical Trial Operations (GCTO) Collaboration with Key Internal Stakeholders The CMD represents Medical Affairs in cross-functional leadership teams and collaborations and advocates for the interests of the country (or cluster) with regional and global colleagues Country (or Cluster) Leadership Team Represents Medical Affairs and is the medical voice in the country (or cluster) executive management team Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), and Global Clinical Scientific Affairs (GCSA) Supports GCTO when requested Manages the submission and our Research & Development Division roles in the conduct of investigator-initiated studies. Leads country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitates Chief Medical Officer (CMO) approval of these requests Center for Observational and Real-World Evidence (CORE), Market Access, Regulatory Affairs, HH, and Policy Interacts with CORE, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies Collaborates with CORE, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for Our company's entire portfolio of medicines and vaccines Provides medical expertise to the commercial product teams, ensuring the scientific and medical value of Our Company's products across all therapy areas Engagement with Key External Stakeholders The CMD represents Our Company as an executive leader and scientific expert to the external community. Serves as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions, and the broader scientific community to lead and execute the medical research and implementation strategy for Our company s innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs (e.g., scientific advisory boards, scientific leader (SL) engagements, webin...

Job Description Key Account Manager THE OPPORTUNITY Key Account Manager is responsible for Efficiently manage the therapy area by effectively reaching out to customers and increases product awareness, answer queries and introduce new products. Also responsible for Customer Focus and have industry knowledge and schedule and plan the frequency of calls and personally visit the targeted doctors as per agreed coverage list. Based in Mumbai, named one of the Best Companies for Women in India by Avatar, 2019, 2020 and 2021. Join the premier biopharmaceutical company that has been in Asia Pacific for over 60 years. Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources.We support healthcare providers and healthcare systems meet the goals of the patients in their communities. Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. WHAT YOU WILL DO Key Responsibilities: Customer Focus and Coverage Proficient with the therapy and product related features/benefits including scientific information thereto, so as to effectively communicate with the medical doctors and handle product related customer queries. Actively participate in identifying key and potential medical practitioners and specialists in the respective therapeutic segment in the assigned territory, and prioritize for the purpose of systematic customer coverage so as to generate maximum prescription sales for the company s range of products as per business plan. Schedule and plan the frequency of calls and personally visit the targeted doctors as per agreed coverage list. Call on the Chemists, wholesalers as the case may be to track in-market sales of the products, booking of orders to ensure timely and adequate availability of products to meet market demand. Utilize customer focused selling techniques (CSSP), continually assessing the knowledge of the customer and strategize to maintain high customer confidence and customer knowledge of company products. Maintain current, approved protocol (CSSP) and promotional materials to be included in sales presentation/ detailing. Contact customers on regular basis and deliver informative sales presentations based on customers need. Constantly explore opportunities to develop new business within assigned therapy area. Sales Performance & Results Achieve and exceed the sales targets on a consistent basis through effective implementation of the sales promotion strategies and follow-up initiatives. Specialist in the product knowledge, therapy knowledge and detailing skills so as to enhance productivity levels as expected by the Company. Carry out Product Visibility and such ancillary or incidental activities related to the Products of the Company or Products of any other Company as may be decided from time to time, in accordance with any arrangement or agreement entered into by the Company with such other Company. Explore opportunities to develop new businesses within assigned therapy area. Planning & Sales Performance Management Tactically plans to generate tertiary demand generation Plans and executes field working as per approved tour programmes so as to cover all stakeholders as per decided frequency Takes follow-up initiatives on feedback and customer service requirements. Handles special product campaigns, new product launch campaigns as perCompany s plans. Covers the Nursing homes, clinics and hospitals as per agreed coverage requirements Collects data on annual budget for medicines, mode of purchase, rate contract/tendering etc. as may be required and takes initiatives to tap these business growth avenues. Assists in the collection of receivables, as per company policy. Key Account Management To nurture strategic relationships with top accounts, so a KAM must possess an in-depth knowledge of the company and its customers. KAMs need to have a strategic perspective that goes beyond short-term gains. They must be able to juggle many moving parts and orchestrate deals and long-term plans that align with a mutually beneficial strategy. Communication Meets Actively participate in Cycle meetings, periodic Sales & Marketing meeting and conventions. Conducts group meetings, medical education camps, speaker programmes as may be necessary from time to time for assigned therapy area. Guides and helps other team members within therapy area to design and execute scientific activities as per experience. Coaching and supervision Actively participate in training, orienting and handholding the new comers To be a Mentor to the Trainees, probationers and freshly inducted sales professionals in the assigned therapy area. Expert in the therapy area and constantly providing guidance and coaching to TMs and STMs as per need. To sanction leave of the sales professionals, as per company procedure. Liaising with the Stockists and distributors in connection with customer service requirements. Provides guidance and coachingto TMs as per need. To approve claims upto prescribed limits of authorized stockists, distributors, retailers in respect of breakages, date expiry, spoilage etc after due verification. In case of larger claims, provide accurate and vital inputs to the Management to take appropriate action. Company, Industry & Product Knowledge Demonstrate above average knowledge of all company marketed products, disease, therapy area, competitor products, promotional strategies and objectives. Develops a clear understanding of the Company s SOPS and protocols pertaining to his area of work. Imbibes the guidelines pertaining to Adverse Event Reporting and takes prompt action in compliance with the requirements. Market Analysis Maintain quality customer list, current profile of assigned key accounts, key influencers & clinical thought leaders....

Description 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/ Position Summary The Senior Statistical Programming Lead is an experienced Statistical Programmer with advanced knowledge of statistical programming methods, languages and data structures and capabilities in leading analysis and reporting activities and programming teams in accordance to departmental processes and procedures. This position is accountable for the planning, oversight and delivery of statistical programming activities supporting one or more clinical projects, compounds and/or submissions generally of low-medium complexity/criticality. The Senior Statistical Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction and technical and project specific guidance to programming teams. As an experienced Statistical Programmer this position applies advanced technical and problem-solving skills to complete programming activities of high complexity that may benefit multiple project teams. In addition, the Senior Statistical Programming Lead may contribute advanced knowledge and technical skills to Therapeutic Area or departmental innovation and process improvement projects. Principal Responsibilities As a Programming Lead; Accountable for Statistical Programming team delivery for one or more clinical projects generally of low to medium complexity, scope or criticality. Coordinates and supervises programming team activities and provides technical and project specific mentorship to programming team members to ensure quality and timely statistical programming deliverables in compliance with departmental processes and procedures. Develops detailed programming strategy, specifications and plans the programming deliverables for a one or more clinical projects. May act as a section lead of programming activities supporting a clinical program, compound or submission. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates optimally with statistical programming and cross-functional team members and counterparts to achieve project goals. As applicable, coordinates statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality. As an experienced Statistical Programmer; Designs and develops programs in support of sophisticated clinical data analysis and reporting activities. Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality. May contribute to or lead others in an area of expertise that results in solutions growing the efficiency and quality of deliverables across multiple projects. May play the role of a Therapeutic/Disease Area Expert contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships Reports into people manager position within the functional area. Accountable to the Statistical Programming Portfolio Lead for assigned programming activities and responsibilities. Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Clinical Trial Lead, Quantitative Sciences, Biostatisticians, Regulatory, Clinical - Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications Qualifications - External Bachelor's degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 6-8 years programming experience with growing responsibility, preferably in a pharmaceutical/clinical trial environment. Advanced knowledge of relevant statistical programming languages including SAS (required), other relevant programming languages (e.g. R, Python etc. preferred), and data structures. Proven experience planning and coordinating programming activities and leading teams. Proven experience working with cross functional stakeholder and teams. Solid understanding of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Basic project management skills. Demonstrated written and verbal communication skills. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Qualification : Bachelor's degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth).

Description Title of Position: Professional Development Lead, Vision Care INDIA Reports to: BUD / General Manager, Vision Care INDIA The Professional Development Lead aims to lead, develop, and guide the integration of educational and curriculum initiatives, with a primary focus on raising the standards of eye health professionals and enhancing awareness and fitting excellence of contact lenses. His/ Her s Key role would be to develop Strategies In line with Countries business objective. Accordingly Plan, Lead and Execute Fitting Training / NPI Launches and track and build data led insights on training \WORKING RELATIONSHIPS Internal and external contacts. Internal: Direct Reporting and Regular engagement with Country BUD Cluster PD Lead: To empower with all training material and guidance to improve quality and engagement of professional training in the market Engage with Local Sales Team, Relevant India Cross Functional Team to build road map and execution plans for internal professional training External: ECP s of IO s Top Stores & Medium Stores ECP s of NKA s GKB, Lenskart, Titan, Himalaya etc. Agencies, Trainers, etc. KEY ACCOUNTABILITIES 1. Education and Curriculum Development: Lead Develop and Execute Professional strategy in line with country s overall business objectives. Lead and shape the market professional strategy, market training plans and materials (such as educational 3D animations and videos), in execution of a fully integrated closed-loop professional and patient experience. Represent India s Professional Lead for Internal stakeholders- Lead cross-functional teams to operationalize business strategies relevant to training that leverage innovation, digital technologies, and new methodologies that generate value, growing category penetration, and achieve business results. Develop relevant educational materials, tool kits, case studies, trials and ensure strong representation in the partnership stores IO s and NKA s Lead member of the local copy clearance process to ensure all technical / clinical information of JJVC India materials are factually correct and claims are fully substantiated for both internal and external communications 2. Raising Standards: Elevate India s standard of education, Trials & execution in-market professional communications & engagement against business plans that grow ACUVUE Brand equity, usage, penetration, consumption, and loyalty. Co-create with marketing world-class ECP education & certification. Lead business analysis and development of an annual professional plan & content in line with strategic priorities to grow category and shares, countering competitor activities. 3. Team Leadership: Lead business-planning sessions, drive marketing initiatives, and act as a team leader managing resources of professional projects. Coach & mentor members that we will hire on requirement 3P project basis to engage with Key Stores via periodic catch up & project collaboration. 4. Awareness and Fitting Excellence: Engage, align, and collaborate with Local Vision Care team & STAR Professional Team in leveraging to develop groundbreaking patient & ECP communication campaigns, including online & offline/ in-store and large-scale events Support & influence the delivery of clinical claims regarding NPI execution and existing products. 5. Stakeholder Engagement and Thought Leadership: Align, leverage Local/ Star Professional guidance to support sales team gaining focus portfolio MS in Store via training and trails & check through regular - Mystery Shopping and other consumer/ competitor/ professional insight market research studies lead by Marketing Closely Collaborate to shape in-country efficient Professional Plan and execution and BME allocation for the same with clear plan tracking of Impact Lead & represent India key meetings as well as business reviews to maximize support for the country to accelerate growth. Foster market collaboration & DEI. WAYS OF WORKING Three-way transparent communication with local Markets & Cluster Professional Team Early alignment on key measures of success to ensure efficient use of time and resources Close working relationship with local Marketing, Sales Team ( IO s and NKA s); Compliance to ensure seamless & impactful execution, while ensuring Business Unit Head is kept informed and involved in key decision making processes This position plays a pivotal role in advancing education, raising professional standards, and increasing awareness and fitting excellence for contact lenses and ACUVUE brand lenses in the country. Qualifications MBA from a premier institute Qualification : MBA from a premier institute

Biomedical Engineer - Field Operations Location: Mumbai Department: Operations Customer Success (Field) 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 by improving patient safety, enhancing outcomes, and reducing healthcare costs through innovative, AI-driven technologies. Trusted by hospitals in India, the USA, and Africa, Dozee is revolutionizing healthcare with cutting-edge solutions. Role Overview As a Biomedical Engineer in Field Operations, you will be the face of Dozee at partner hospitals. This role involves conducting product demonstrations, installing and troubleshooting Dozee devices, and training healthcare professionals on device usage. You will ensure that the deployment and functionality of our solutions meet the highest standards, contributing to better patient outcomes and enhanced operational efficiency. Key Responsibilities Product Demonstrations & Installations Conduct live demonstrations of Dozee s devices at hospitals, showcasing their features and benefits to healthcare professionals. Install Dozee devices, ensuring proper setup and smooth functionality. Provide troubleshooting and technical support during and after installations. Training & Support Train healthcare professionals (nurses, doctors) and patients on how to use Dozee devices and the patient monitoring dashboard. Provide ongoing technical support and assistance, ensuring the devices are used effectively. Gather feedback from end-users to identify opportunities for improvement. Site Assessments & Coordination Perform site assessments to understand hospital requirements and communicate device needs to the remote team. Coordinate with remote teams to relay updates and ensure timely resolution of issues during site visits. Relationship Building Build and maintain strong relationships with healthcare professionals to foster trust and collaboration. Ensure clear, consistent communication between Dozee and hospital staff. Requirements Education & Experience Graduation or Diploma in Science, ITI, or a related field. 0-2 years of field operations or field sales experience in the healthcare or hospital industry. Prior experience working with doctors/nurses is preferred. Skills Basic understanding of computer operations and familiarity with technical tools. Excellent communication skills, with fluency in local languages. Willingness to travel within the city and work in hospital wards. Open to working night shifts occasionally as required. Why Join Dozee Be part of an innovative, mission-driven company revolutionizing healthcare with AI. Opportunity to directly impact patient safety and operational efficiency at top hospitals. Work with a team that has already monitored 1M+ patients and saved over 10 million nursing hours. Qualification : Graduation or Diploma in Science, ITI, or a related field

Director Quality & Regulatory Affairs Location: Mumbai, India Employment Type: Full-time Job Description We are seeking an experienced Director of Quality & Regulatory Affairs to lead our regulatory and quality initiatives at the company. This critical leadership role will involve direct oversight of regulatory submissions, quality management systems, and cross-functional collaboration to ensure compliance with global standards. As the regulatory affairs expert, you will navigate complex regulatory pathways, oversee quality systems, and ensure compliance with evolving standards to drive global market entry and product success. Roles & Responsibilities Regulatory Affairs & Compliance Leadership Serve as the primary point of contact for regulatory agencies globally, managing pre-submissions, submissions, and post-market regulatory activities. Lead the development of regulatory pathways, clinical study designs, and regulatory negotiations, ensuring alignment with regulatory requirements. Stay up-to-date with evolving regulations (e.g., EU MDR, ISO 13485, IEC 62304, ISO 14971) and advise on strategic regulatory implications. Quality Management System (QMS) Oversight Ensure the organization s adherence to QMS policies and regulatory standards such as ISO 13485 and FDA guidelines. Oversee internal and external audits, including preparation, issue resolution, and coordination with external auditing bodies. Manage documentation for Corrective and Preventative Actions (CAPA), ensuring effective communication and resolution with all stakeholders. Cross-functional Collaboration & Strategy Collaborate with various internal teams to develop regulatory strategies for product development, market approval, and strategic planning. Advise teams on regulatory affairs, guiding research directions and influencing strategic product decisions to align with global regulatory requirements. Product Validation & Compliance Develop and review validation documentation for Software as a Medical Device (SaMD) and Computer-Aided Design (CAD) devices to ensure regulatory compliance. Review product labeling, marketing materials, and customer-facing statements for regulatory compliance, offering guidance and recommendations where necessary. Regulatory Documentation & Monitoring Lead the preparation and submission of EU MDR filings, ensuring timely and complete documentation. Monitor ongoing regulatory developments and perform regulatory gap analyses to identify and respond to new or revised regulatory requirements. Success in this role is defined by ensuring our products consistently meet or exceed global regulatory compliance standards, aligning cross-functional teams with regulatory requirements throughout product lifecycles, and effectively navigating regulatory pathways to support timely market entry and ongoing compliance. Requirements Proven experience in a senior regulatory role within an AI medical device company. Extensive knowledge of EU MDR, QMS, and medical device regulations. Master s degree in a technical discipline (preferred), RAC certification is a plus. Strategic thinking with the ability to align regulatory requirements with portfolio opportunities and company goals. Strong project management skills, with the ability to multitask and manage cross-functional teams in a dynamic, fast-paced environment. Exceptional written and verbal communication skills for clear documentation, presentations, and discussions. Demonstrated commitment to quality and continuous improvement, with a proactive approach to identifying and addressing regulatory challenges. Why This Role Is Important In this leadership position, you will drive compliance efforts across the organization, ensuring that all products are designed, developed, and released in compliance with global standards. Your role will be central in shaping the regulatory strategies that enable the company to enter global markets and maintain regulatory excellence. Equal Opportunity Employer We are committed to fostering an inclusive and diverse workforce. We encourage applications from candidates of all backgrounds and experiences. Qualification : Masters degree (technical discipline preferred); RAC certification is a plus.

Senior Client Partner Location: Mumbai, India Employment Type: Full-time, Permanent About Qure.AI Qure.AI is the world s fastest-growing medical AI company, with an impressive track record of 13 FDA and 62 CE mark clearances. We develop cutting-edge solutions to enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted over 22 million patients in more than 90 countries worldwide. At Qure.ai, we are committed to fostering a diverse and inclusive workplace, and we proudly serve as an equal-opportunity employer. About the Job We are seeking a Senior Client Partner to lead large-scale, countrywide projects and manage key client relationships. This role involves driving revenue growth through upselling, cross-selling, and strategic account management. As part of the Customer Success & Operations team, you will be instrumental in ensuring smooth project execution and fostering long-term partnerships. In this position, you ll oversee client journeys with Qure.ai, driving product adoption, optimizing impact, and identifying opportunities for expansion and renewal. This is a high-impact role that combines client management, project execution, and strategic planning in a rapidly growing organization. Roles and Responsibilities Lead Large-Scale AI Projects: Drive the execution of large-scale, countrywide AI projects from start to finish, ensuring smooth implementation and client satisfaction. Collaborate with government bodies, healthcare institutions, on-ground teams, and global health organizations to drive product adoption and large-scale AI deployment. Client Relationship Management: Build and maintain strong relationships with key external stakeholders, including Ministry of Health, National Programs, program heads, IT teams, and clinical decision-makers. Ensure high retention and satisfaction, and serve as the primary point of contact for client management, post-deployment engagement, and feedback collection. Revenue Growth: Identify new opportunities within existing accounts, driving upselling, cross-selling, renewals, and expansions. Manage strategic account planning to maximize client lifetime value and ensure continuous revenue growth. Cross-Functional Collaboration: Work closely with engineering, product, and sales teams to support client needs, resolve project challenges, and deliver exceptional results. Provide valuable feedback to product teams to contribute to Qure.ai's product roadmap and continuous improvement. Best Practices and Process Optimization: Develop best practices for client management, project execution, and revenue tracking. Continuously optimize internal processes for improved efficiency, scalability, and long-term impact. Client Support: Effectively resolve client complaints by collaborating with Client IT and Program Teams, managing remote access requests, and ensuring timely resolution of issues in coordination with internal engineering teams. Marketing & Research Outcomes: Generate marketing and research outcomes that highlight the impact of Qure.ai s solutions and reinforce our value proposition in the healthcare AI space. Skills and Expertise Experience: 3-6 years in client-facing roles, with experience in managing large-scale, multi-stakeholder projects and driving revenue growth through upselling, cross-selling, and strategic account expansion. Project Management: Strong people management skills and the ability to lead projects in a fast-paced, evolving environment. Experience in account management, client success, project management, or healthcare is a plus. Communication Skills: Excellent verbal and written communication skills, with a demonstrated ability to engage with and influence senior-level stakeholders. Problem-Solving: Self-starter, quick learner, and a driven individual with strong problem-solving capabilities and empathy toward clients. Healthcare Knowledge (Optional): Knowledge and experience in the healthcare industry will be advantageous. Technical Skills: Proficient in Excel and PowerPoint for reporting and presentations. Other Considerations Travel Requirements: This role will involve significant travel, both domestic and international, to ensure successful project execution and client engagement. At Qure.ai, you will be part of a rapidly growing organization where you can work alongside the best minds in the healthcare and AI industries. We offer competitive compensation, a rewarding career path, and the chance to make a meaningful impact in global healthcare. As a Senior Client Partner, you will have the opportunity to grow with a young, innovative company and help shape the future of healthcare AI. Equal Opportunity Employer Qure.ai is committed to fostering a diverse and inclusive workplace. We encourage applicants from all backgrounds and experiences to apply.

AI/ML Developer Location: Mumbai Experience: 5+ years Key Responsibilities: AI/ML Solutions Development: Develop, deploy, and maintain scalable AI/ML solutions tailored to the healthcare industry. Data Preprocessing & Structuring: Collaborate with data engineers and analysts to preprocess, clean, and structure healthcare data for machine learning applications. Model Design & Implementation: Design and implement machine learning models for real-world healthcare challenges like patient readmission prediction, disease progression modeling, and medical image analysis. Production Integration: Integrate AI/ML solutions into production environments, ensuring models are efficient, reliable, and meet client goals. Client Collaboration: Work with healthcare clients to define project requirements and KPIs, ensuring the solution brings measurable value. AI/ML Advancements: Stay up to date with the latest advancements in AI/ML, particularly in healthcare, and integrate new techniques to improve solutions. Regulatory Compliance: Ensure all AI/ML applications meet healthcare regulations (e.g., HIPAA, GDPR) and maintain high standards for patient data privacy and security. Model Monitoring & Optimization: Monitor, fine-tune, and update models post-deployment to maintain optimal performance and adapt to evolving healthcare data. Requirements: Experience: 5+ years in AI/ML, deep learning, and machine learning applications, preferably in the healthcare industry. Technical Skills: Proficiency in Python and/or R, with experience in ML libraries like TensorFlow, PyTorch, Scikit-Learn, etc. Healthcare Data Expertise: Strong understanding of healthcare data types and sources (e.g., EHR/EMR data, claims data, imaging data, genomics). Cloud Platforms: Familiarity with cloud platforms (AWS, Azure, Google Cloud) and deploying ML models in these environments. Healthcare ML Use Cases: Experience in healthcare-specific ML use cases such as patient outcome predictions, medical image classification, and NLP for clinical notes. Regulatory Knowledge: Strong understanding of healthcare privacy and regulatory standards (e.g., HIPAA, GDPR). Communication Skills: Excellent problem-solving, analytical, and communication skills, with the ability to convey complex technical ideas to non-technical stakeholders. Shift Flexibility: Ready to work in shifts to accommodate the global nature of healthcare projects. If you're passionate about developing impactful AI/ML solutions in the healthcare industry and have the required expertise, apply now for the AI/ML Developer position in Mumbai!

Job Title: Assistant Procurement Manager - Homecare Innovations Department: Procurement Profession: Supply Chain Work Location: Mumbai, India Reporting Manager: Procurement Lead Homecare, South Asia About Unilever Unilever is a global company that serves 3.4 billion people across over 190 countries with a diverse range of products. We strive to create brands that improve lives, both for our consumers and the communities we operate in. Our purpose is to brighten everyday life for all, and we work with a deep sense of purpose, collaborating in an environment that supports diversity, equity, inclusion, and belonging. About Procurement Procurement at Unilever is integral to the supply chain, overseeing material and service spend of over 30 billion euros globally, with over 60,000 suppliers. Our role is to bring innovation to meet evolving consumer needs, ensuring responsible procurement practices while delivering financial value. With a focus on "Procurement with Purpose," we aim to purchase responsibly, buy better, and grow with our partners. Main Job Purpose The Assistant Procurement Manager for Homecare Innovations will manage the procurement side of innovations, focusing on product launches and relaunches within the Homecare (Laundry and Household Care) category. You will partner with internal stakeholders, including brand teams, R&D, Supply Chain, and Quality, as well as external suppliers to ensure timely, cost-effective innovation delivery. The role also involves driving savings and supporting the South Asia cost savings target. Key Responsibilities Innovation Management: Lead procurement efforts for Homecare Innovations in India, attending and representing procurement in innovation network meetings. Collaborate with internal and external stakeholders to gather inputs for costing, trials, and launches. Stakeholder Collaboration: Work with suppliers, R&D, global buyers, and other stakeholders to drive the innovation agenda. Ensure connectivity for material trials and product launches. Supplier Relationships: Build and maintain strong relationships with suppliers, ensuring strategic alignment for innovation, savings, and sustainability goals. Forecasting & Business Case Support: Provide material price forecasting to support business case preparation and assist in launching new products. Cross-functional Coordination: Collaborate with various departments such as Brand, R&D, Finance, and Procurement for innovation (re)launches and product renovations. Strategic Updates: Present regular updates to internal stakeholders and flag any issues or concerns regarding innovation processes or suppliers. Supplier Development: Interact with suppliers to develop innovative solutions aligned with Unilever s clean future agenda and ongoing savings initiatives. Project Management: Effectively manage and track innovation projects, holding stakeholders accountable for their roles and ensuring timelines and budgets are adhered to. Challenges Building Effective Relationships: Establishing and maintaining strong relationships with a wide range of internal stakeholders (Brand, Procurement, R&D, Finance, etc.) and external suppliers. Cross-functional Coordination: Navigating different organizational and cultural boundaries to manage diverse project needs without direct hierarchical control. Required Skills & Competencies Educational Background: Minimum a science graduate with 5+ years of experience in product/process development, innovation network management, or procurement within the FMCG sector. Relevant Expertise: Experience in Product/Process Innovation, Supply Chain, or Technology Deployment. Project Management: Strong project management skills with the ability to drive initiatives forward and meet deadlines. Stakeholder Management: Ability to manage a diverse set of internal and external stakeholders, especially suppliers. Analytical & Problem-Solving Skills: Strong ability to analyze situations and create actionable solutions to meet business needs. Excel & PowerPoint Proficiency: Advanced skills in Excel and PowerPoint for reporting and presentations. Influencing Skills: Excellent communication and influencing skills to drive decision-making and change. Experience Requirements 5+ years of relevant work experience in Product/Process or Technology development, Supply Chain/Network management, or a similar role within FMCG. Exposure to Homecare formulations/raw materials is preferred. Travel: Limited travel (~25%). Internal & External Contacts Internal: Procurement teams (Global & Local), Brand teams, R&D, SUIT, Finance, Quality, SEAC External: Suppliers (New & Existing), Procurement/Market Intelligence agencies Reporting Structure Procurement Director South Asia Sr. Procurement Manager - Chemicals HC Assistant Procurement Manager - HC Innovations Diversity & Inclusion Statement Unilever is an Equal Opportunity Employer and values diversity. We encourage applicants from all backgrounds and experiences to apply, and we commit to creating a workplace that is inclusive, supportive, and fair. We do not discriminate based on race, color, religion, gender, sexual orientation, disability, or any other basis protected by applicable law.

Description The Sr Specialist will provide support in the CAPA management process and is the responsible Quality Approver. They will be responsible for executing quality reviewer/approver responsibilities for the NC/CAPA Management Process. This includes ensuring timely initiation and completion of investigations and CAPAs, collaborating with key stakeholders to resolve conflicts and align on the path forward, and determining when escalation to stakeholders or senior management is required to resolve issues. The Sr Specialist will have responsibility for ensuring the investigation and CAPA owners are progressing to plan by monitoring status and providing feedback and comments to direct progress during the investigation and root cause analysis/immediate cause phases, and during preparation of Corrective/Preventative action plans and effectiveness monitoring plans. They are knowledgeable and experienced in the CAPA management process and system and can guide and educate issue owners on best practices. Attention to detail, time management skills, and the ability to build and maintain relationships are essential. CAPA reviewer/approver for CAPA Management Process: Facilitate the initiation of investigations and CAPAs, and monitor progress and approvals. Collaborate with key stakeholders to support the end-to-end NC/CAPA process. Ensure that CAPA procedures and requirements are followed and met. Escalate complex issues to CIM management for resolution. Work with stakeholders, senior management, and governance bodies for awareness and resolution, as needed, including any issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. Review evidence and approve closure of CAPA plans. Monitor effectiveness of CAPAs to ensure the Root Cause is eliminated or reduced to acceptable level. Drive key deliverables and ensure timely completion of activities. Support/Provide regular updates for CAPA status, metric reports, and trending, as needed. Participate in and/or support internal audits and regulatory inspections, as needed. Attend, participate and/or facilitate CAPA review meetings, as needed. Perform other duties as necessary. Decision Making and Problem Solving: Ability to work independently and coordinate across CAPA and Issue Management (CIM). Consult with CIM management as need for resolution of complex issues. Requires basic management skills for cross-functional interactions and coordination. Facilitates resolution of issues and able to collaborate with stakeholders at varying levels of management across multiple organizations. A fundamental understanding of the risk management process to engage key stakeholders and mentor colleagues to capture insights and make risk-based decisions. Excellent communication and writing skills demonstrated by the ability to write executive summaries and ad hoc reports promptly and clearly as well as compile and present data to other professionals. Requires analytical skills to examine data and perform analysis. Requires decision-making skills to approve the appropriateness, effectiveness, quality and compliance of documented robust investigations, root cause analysis and corrective/preventative action plans. Working Relationships: Must be able to effectively operate in a matrixed environment and interact with cross functional leaders on a regular basis. Associate Director/Director, CAPA and Issue Management interfaces and informs as needed to discuss issues. CAPA and Issue Management team members interfaces daily as needed to manage workload; interfaces weekly in team meetings. R&D Senior Management, R&D Quality, Regulatory Affairs, Medical Affairs, and other business functions involved in owning investigations and delivering CAPA commitments - interfaces as needed to address identified issues and provide guidance on established processes. J&J partners must be able to effectively interact with third-party organizations, and marketing partners as needed to address cross-company and cross-departmental issues. Qualifications Bachelor s Degree in Life Science or related discipline or equivalent is required. Knowledge and experience with regulations and regulatory compliance issues. At least 3 years of experience in an applicable compliance field and or equivalent experience/training in a related R&D area. Experience with Non-Conformance/CAPA. Analytical and data skills. Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence. Must be a problem solver, strategic thinker, and collaborator. Excellent organization, prioritization, and time management skills. Demonstrated competencies include adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization. Ability to build and maintain cross-functional interactions and coordination. Ability to build consensus, influence, and negotiate. Knowledge in R&D related activities which may include safety related areas, safety reporting for both investigational and marketed products, clinical study coordination, etc. Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices. Qualification : Bachelors Degree in Life Science or related discipline or equivalent is required.

Job Requirements Role/Job Title: Analyst- Enterprise, Network & Reconciliation Function/ Department: Retail Banking Operations - Centralised Control Unit Job purpose: As part of the Retail Operations team, individuals must be well versed with the various digital products and the process defined by regulator & network and should have experience in managing the reconciliation processes. Roles & Responsibilities: Candidate should have prior experience in handling the channel reconciliation/digital banking processes. The candidate should be well versed with the various digital products and the process defined by regulator & network. The candidate should have strong interaction, communication skills to liaison with vendor support/network/peers and good inter person skills to communicate & interact with senior management. The candidate should be well versed with Network provided system as well as expertise in MS office. Good Vendor Management skills in terms of managing third party vendors is required. Managerial & Leadership Responsibilities: The candidate should have experience in managing the reconciliation processes. The candidate should have detailed knowledge of the processes. Key Success Metrics: Subject Matter Expertise in performing the Reconciliation. Subject Matter expert on Network system. Education Qualification: Graduation: Any Post-graduation: Any Experience: 2 to 5 Years of experience.

Job Description: We are seeking a Murex Back Office Specialist with 3 to 7 years of experience, specializing in back-office processes and accounting issues. The ideal candidate will possess a deep understanding of the Murex platform, particularly in the Back Office (BO) stream, and will be an expert in managing post-trade processes, deal validation, nostro settlements, and accounting. As a Murex Back Office Specialist, you will handle the day-to-day operations related to the back office and accounting, ensuring that all processes are executed accurately and efficiently. Responsibilities: Back Office & Accounting Management: Handle back-office and accounting issues, including change requests. Provide support in managing workflow handling, OSP rights, and usage for various asset classes. Oversee nostro settlements, deal validation, and accounting in the Murex platform. Business Requirements & Documentation: Prepare business requirement documents and manage developers for changes. Design layouts and pricing templates based on gathered requirements. Implement necessary changes to the system and prepare for testing. Testing & Issue Resolution: Conduct test case executions and manage user testing. Troubleshoot/debug issues, explain them to stakeholders, and implement fixes. Asset Classes & Configuration: Experience in handling accounting configurations in Murex. Support in the development of OSP, settlement instructions, and accounting configurations for different products. Reporting & Documentation: Generate reports and leverage OSP, static data, and deal bookings for testing. Provide support for document generation, swift/RTGS settlements, and post-trade workflows. Technical Skills & Qualifications: Capital Markets Knowledge: Strong understanding of capital markets and the post-trade life cycle. Murex BO Stream Knowledge: Experience with Murex BO stream, particularly dealing with deal validation, cashflow position monitoring, nostro settlements, accounting, and OSP handling. SQL & Mx-Excel: Proficiency in SQL and Mx-Excel for analysis, troubleshooting, and reporting. Post-Trade Rules & Configuration: Experience with post-trade rules, document generation, and settlement configurations in Murex. Experience in Asset Classes: Exposure to major asset classes and knowledge of how Murex handles these processes throughout the trade life cycle. Experience: 3 to 7 years of hands-on experience working with Murex, specifically in back-office processes. Strong understanding of settlements, accounting, and configuration management in the Murex environment. Proficient in developing OSP, settlement instructions, and accounting configurations for various asset classes. Synechron s Diversity & Inclusion Statement: Diversity and Inclusion are at the heart of Synechron's culture. We strongly believe that a diverse workforce fosters stronger businesses and an environment where everyone can excel. We are an equal-opportunity employer and encourage applicants from diverse backgrounds, ethnicities, genders, sexual orientations, religions, and abilities to apply. Our commitment to Diversity, Equity, and Inclusion (DEI) ensures that we create an inclusive environment that fosters equality for all.

Job Title: Associate Underwriting Location: Mumbai, India Company: Oakbrook (Part of Blenheim Chalcot Portfolio) Experience: 1 3 Years Industry: FinTech | Lending | Underwriting Employment Type: Full-Time About the Role: We are looking for a highly analytical and detail-oriented Associate Underwriting to join Oakbrook India, a FinTech venture within the Blenheim Chalcot ecosystem. You will play a critical role in supporting loan underwriting processes, document verification, and financial data analysis to ensure accurate risk assessment and timely decisions. You ll gain exposure to next-gen GenAI-enabled processes and will work in a fast-paced, agile, and collaborative environment, contributing directly to the future of digital lending. Key Responsibilities: Review loan applications and verify customer documentation for completeness and accuracy. Analyze financial statements, bank statements, credit reports, and related documents to assess creditworthiness. Prepare detailed customer risk profiles and support the underwriting team in decision-making. Identify discrepancies or red flags and escalate as required. Ensure compliance with internal policies and lending regulations. Collaborate with cross-functional teams including Customer Service, Risk, and Operations. Support process enhancements through automation and tech-driven tools including GenAI. Maintain accurate and well-documented audit trails of decisions and processes. Must-Have Skills: Experience in document verification and financial data analysis (bank statements, credit reports, income data, etc.). Strong understanding of lending operations and underwriting processes, especially for UK/US clients. Analytical thinking and decision-making ability with attention to detail. Good-to-Have Skills: Familiarity with GenAI tools or automation platforms in financial workflows. Clear stakeholder communication and reporting abilities. Proficient in MS Office tools, especially Excel. Qualifications: Graduate or Undergraduate from a recognized university. 1 3 years of experience in FinTech, lending, or mortgage operations, ideally with UK/US-based clients. Exposure across the lending customer lifecycle (call center, back office, retention) is an advantage. Strong documentation, compliance, and reporting awareness. What We Offer: Competitive compensation based on experience. Opportunity to work with global teams and FinTech leaders. Be part of Blenheim Chalcot, the world s leading digital venture builder. Exposure to the latest in GenAI and automation technologies. Private medical insurance for you and your family. Life insurance coverage. Vibrant work culture with regular social events and team activities. About Blenheim Chalcot: Blenheim Chalcot has been building disruptive businesses for over 26 years across FinTech, EdTech, HealthTech, Media, and more. Our India team is central to our innovation and success, supporting a diverse portfolio of ventures. We re not just investors we build businesses from the ground up, supporting them with strategic expertise and execution capabilities in technology, growth, talent, finance, and legal. If you have an eye for detail, love working with financial data, and want to be part of a purpose-driven FinTech team, we want to hear from you.