Clinical Trial Documentation Jobs in Mumbai

Associate - Drafting Location: Mumbai Group Company: KEC International (A part of RPG Enterprises) About KEC International KEC International is the flagship company of RPG Group and a major player in the Engineering, Procurement, and Construction (EPC) sector. Operating in Power Transmission & Distribution, Railways, Civil, and more, KEC is a USD 2.1 billion company with a global presence across over 105 countries. Job Description: Electrical Draughtsman The ideal candidate will have hands-on experience in drafting work for AIS (Air Insulated Substations) and GIS (Gas Insulated Substations), with a strong understanding of EHV (Extra High Voltage) systems and equipment. The role involves creating detailed electrical layouts, diagrams, and foundation plans. Key Responsibilities Prepare General Arrangement drawings for AIS & GIS substations. Draft Electrical Single Line Diagrams (SLDs) for HV/EHV Substations and LT systems. Develop electrical layouts including sections, earthing, and lightning protection systems. Create Erection Key Diagrams, Foundation Plans, Cable Trench Layouts, and Cable Schedules. Design Panel Arrangement Layouts, Lighting Layouts, and Conduit Layouts. Estimate quantities and prepare Bill of Materials (BOM) for electrical installations. Coordinate with civil and mechanical teams to ensure design integration and accuracy. Ensure compliance with ANSI codes and IEC Clearance requirements. Required Skills & Software Proficiency AutoCAD: Mandatory expertise for drafting and design work. BIM 360 and Revit: Experience is an added advantage. MS Office: Proficiency in Word and Excel for documentation and scheduling. Dialux: Knowledge for lighting design is a plus. Education & Certification Education: Bachelor s Degree in any stream or Diploma in Electrical Engineering. Certifications: AutoCAD Certification is mandatory; BIM & Revit certification is a plus. Language: Ability to read and write in English for technical documentation. Experience Required: Previous experience in drafting for AIS & GIS Substations. Familiarity with EHV systems, electrical equipment, and substation layouts. Strong attention to detail and ability to coordinate with various technical teams. Understanding of safety standards and compliance regulations. Work with a global leader on high-impact, large-scale infrastructure projects. Gain exposure to cutting-edge engineering technologies and innovative techniques. Professional growth in a collaborative and supportive environment. Qualification : Bachelors Degree in any stream or Diploma in Electrical Engineering

Designation: Senior Engineer Location: Mumbai Department: R&D Qualification: B.Tech / B.E in Electronics / Electronics & Communication / Electronics & Telecommunication Experience: 5+ years (exclusively in Electronics Design & Development) Required Skills & Expertise Practical hands-on experience with: Operational Amplifiers (OpAmp) and their applications. DC-DC converters, Low Dropout Regulators (LDOs), thermal calculations, and heatsink selection. Relays and their applications. Diodes, MOSFETs, BJTs, Optocouplers and their real-world usage. Protection devices such as MOV and TVS. Microcontrollers and pin mapping. Communication protocols including CAN, SPI, I2C, Parallel, RS232, RS485, Ethernet, USB. Switch Mode Power Supply (SMPS) design and PCB layout guidelines. EMI/EMC design and testing. Job Description & Responsibilities The candidate will own the product development lifecycle from initial specification through design, validation, and final production, including documentation at every stage: Design & Development Design and implement low-power analog circuits (op-amps, filters, power circuits, BJTs, FETs) and digital circuits (logic gates, microcontrollers, memories). Draft specifications, plan design architecture, create circuit schematics, select components, prepare BOMs, and coordinate procurement. Simulation & Analysis Perform circuit tolerance analysis using Excel, Spice-based Monte-Carlo simulations, TINA, or equivalent tools. Compliance & Standards Design and develop products compliant with hazardous location standards and railway safety standards (IEC, EN, UL, CE), focusing on intrinsic safety, functional safety, and EMI/EMC requirements. Testing & Validation Bring up PCB assemblies and develop low-level hardware test plans to verify design functionality. Debug hardware using oscilloscopes, digital multimeters (DMMs), logic analyzers, and other test equipment. Generate detailed test plans and reports for electrical and environmental compliance tests. Production Support Assist in prototype fabrication including procurement, build processes, and testing. Analyze and modify designs for end-of-life (EOL) considerations, manufacturing feedback, or customer issues. Documentation Document design processes, testing procedures, validation results, and create jigs or fixtures for validation purposes. Additional Expectations Collaborate effectively with cross-functional teams including manufacturing, procurement, and quality assurance. Drive continuous improvement by troubleshooting and resolving design and production issues. Ensure design practices align with company policies and industry best practices for quality and reliability. Qualification : B.Tech / B.E in Electronics / Electronics & Communication / Electronics & Telecommunication

Job Title: Accounts Payable Senior Executive Location: Mumbai Experience: 2 5 Years Education: B.Com / M.Com / Semi-qualified CA / CA IPCC Cleared Position Overview: We are looking for a detail-oriented and proactive Accounts Payable Senior Executive to join our Finance team in Mumbai. This role involves the end-to-end management of vendor payments, invoice processing, TDS/GST compliance, and period-end financial activities. The ideal candidate will have strong accounting knowledge, hands-on experience with ERP systems, and the ability to maintain efficient vendor relationships while supporting audits and financial reporting. Key Responsibilities: Invoice Processing & Booking Review vendor invoices against contracts/agreements and ensure proper approvals Accurately book invoices with correct GL codes and cost center tagging Deduct TDS as per applicable tax provisions and ensure proper documentation Vendor Payments Schedule and process vendor payments in a timely and accurate manner Conduct due diligence before processing payments (agreements, tax, compliance checks) Maintain payment records and coordinate for necessary internal approvals Vendor Reconciliation & Management Perform regular vendor reconciliations and resolve any mismatches or discrepancies Manage vendor master data, including validation of KYC documents and bank details Liaise with vendors to ensure timely submission of invoices and balance confirmations Expense Monitoring & Analysis Monitor and analyze expenses on a monthly/quarterly basis Identify trends, variances, or unusual cost spikes and flag for further investigation Track outstanding payables to ensure timely closures Month-End & Year-End Activities Book expense provisions and accruals during closing periods Handle amortization of prepaid expenses and related accounting entries Assist in preparing audit-ready reports and reconciliations Reporting & MIS Generate and circulate expense MIS, vendor ageing, and payables reports Coordinate with internal teams for budgeting and clarification on expense entries Compliance & Audit Support Ensure strict compliance with TDS and GST regulations Assist in TDS return filing and timely issuance of Form 16A to vendors Support internal and statutory audits with required documentation and schedules Qualifications & Skills: CA IPCC (one or both groups) cleared preferred B.Com / M.Com / Semi-qualified CA with relevant experience 2 5 years of hands-on experience in Accounts Payable or general accounting Strong understanding of accounting principles, TDS, and GST compliance Proficiency in MS Excel and ERP systems (Tally, SAP, Oracle, etc.) Strong analytical, communication, and vendor management skills Ability to meet tight deadlines with a proactive and solution-oriented mindset Qualification : B.Com / M.Com / Semi-qualified CA / CA IPCC Cleared

Senior Engineer Civil Location: Mumbai Experience: 7 10 Years Qualification: Diploma / B.E. in Civil Engineering Employment Type: Full-Time About the Role We are looking for a skilled Senior Civil Engineer to join our Mumbai team. The candidate will be responsible for overseeing civil engineering projects, ensuring quality control, timely execution, and adherence to safety standards. This role involves coordination across teams, site supervision, and ensuring project specifications are met. Key Responsibilities Lead and supervise civil engineering works at the project site to ensure compliance with design, safety, and quality standards. Review and interpret construction drawings, blueprints, and specifications to guide execution. Coordinate with contractors, consultants, and clients to ensure smooth project progress. Monitor daily site activities and resolve technical issues proactively. Prepare project schedules, progress reports, and documentation. Conduct site inspections and ensure quality assurance and control procedures. Manage material procurement, vendor coordination, and resource allocation. Ensure adherence to safety protocols and regulatory compliance on site. Mentor junior engineers and site staff, fostering professional development. Assist in budgeting, cost control, and resource planning. Required Skills & Competencies Proven experience in civil engineering project execution and site management. Strong knowledge of construction methods, materials, and industry standards. Ability to read and interpret engineering drawings and technical documents. Proficient in project management and civil engineering software/tools. Strong communication, leadership, and problem-solving skills. Ability to work independently as well as in a team-oriented environment. Attention to detail and commitment to quality and safety. Preferred Attributes Experience with large-scale infrastructure, commercial, or residential projects. Familiarity with local building codes and statutory regulations. Ability to manage multiple projects simultaneously. Join Our Team If you are a dedicated civil engineer with a passion for project excellence and leadership, join us to contribute to impactful infrastructure projects in Mumbai. Apply today! Qualification : Diploma / B.E. in Civil Engineering

RCA Lead Experience: 6 9 years Location: Mumbai Team: Customer Success About CoinDCX At CoinDCX, we believe Change Starts Together. Over the past six years, we ve grown from India s first crypto unicorn to a community of over 125 million users. We re on a mission to make Web3 accessible to everyone by creating innovative products that tackle accessibility and security challenges head-on. Join us to be part of a passionate team breaking barriers and building the future of digital finance. Inside CoinDCX s Customer Success Team Our Customer Success team is dedicated to helping users get the most out of their CoinDCX experience. We foster strong relationships, provide timely support, and guide users through their digital finance journeys. If you re passionate about customer satisfaction and operational excellence, this is where your impact begins. Your Role As the RCA Lead, you will be the central owner for structured problem-solving across customer experience, product, and operations. You will lead root cause analysis for critical incidents, drive cross-functional collaboration, and ensure sustainable corrective and preventive actions are implemented to reduce recurring issues. What You ll Own Root Cause Analysis & Problem Solving Lead RCA exercises for major customer-impacting issues, operational failures, and escalations. Build and enforce structured RCA frameworks (5 Whys, Fishbone, FMEA) to ensure consistent problem-solving. Conduct thorough post-incident reviews and publish detailed RCA reports with clear, actionable recommendations. Cross-Functional Collaboration Partner with Product, Tech, Operations, Compliance, and Support teams to address root causes and prevent recurrence. Track and follow up on CAPA (corrective and preventive actions) until full resolution. Ensure accountability for long-term solutions over temporary fixes. Data & Reporting Maintain dashboards tracking recurring issues, escalation trends, and RCA completion metrics. Present RCA insights and systemic risk trends regularly to senior leadership. Quantify the business and customer impact of issues, demonstrating measurable improvements post-fix. Governance & Standards Establish and refine SOPs for incident reporting and RCA processes. Train teams and stakeholders on RCA methodologies and problem-solving best practices. Ensure regulatory and audit compliance with thorough documentation of RCA activities. What You Bring 6 10 years experience in Operations Excellence, Quality, Risk, or Customer Experience, preferably in fintech, crypto, BFSI, or high-scale tech environments. Proven expertise in Root Cause Analysis, CAPA management, and incident governance. Strong analytical skills with the ability to work on large datasets and generate actionable insights. Excellent communication skills to simplify complex issues for leadership and stakeholders. Proficiency with tools like JIRA, Confluence, SQL, Excel, and BI dashboards (Tableau, PowerBI, Looker). Strong stakeholder management and cross-functional collaboration experience. Success Metrics Reduction in repeat issues and escalations. Average time to complete RCA and implement preventive actions. Accuracy and adoption of RCA reports across teams. Leadership satisfaction on visibility and management of systemic risks. You are endlessly curious about Virtual Digital Assets (VDA) and Web3, always staying ahead in this fast-evolving space. You take ownership, relentlessly driving impact and excellence. You embrace a We over Me culture, empowering your team and peers. You thrive on change and innovation, pushing beyond limits and convention. Perks That Empower You Design Your Own Benefit: Customize your perks whether gadgets, travel, or pets, you prioritize what matters most. Unlimited Wellness Leaves: Take time off whenever you need to recharge. Mental Wellness Support: Access health experts, counseling sessions, wellness workshops, and team outings. Bi-Weekly Learning Sessions: Stay sharp and grow with ongoing industry knowledge and skill-building. Join Us If you re ready to lead problem-solving at scale and shape the future of customer experience in Web3 we want to HODL you on our team!

Job Title: Quality Supervisor Location: Mumbai Experience: 4 5 Years Industry: Real Estate / Construction Role Overview: We are seeking a detail-oriented and proactive Quality Supervisor to ensure that all construction activities meet the highest quality and compliance standards. The ideal candidate will oversee material verification, quality assurance processes, statutory compliance, and certification efforts in line with industry best practices and regulatory requirements. Key Responsibilities: Quality Control Conduct physical inspection of construction materials such as bricks, sand, aggregates, and fly ash bricks to ensure compliance with specified quality standards. Monitor and ensure all construction work adheres to international concrete and building standards. Regularly review safety practices at construction sites and office premises, ensuring adequate safety protocols are in place and followed. Process & Policy Implementation Implement and continuously improve quality control processes and systems across project sites. Foster a culture of quality awareness among site teams through effective communication and training. Prepare and maintain comprehensive checklists for material and structural testing; ensure strict adherence to testing protocols and documentation standards. Statutory Compliance Ensure full compliance with environmental and pollution control guidelines to avoid penalties or legal issues. Prevent the use of substandard materials or improper construction techniques that could lead to regulatory action or structural failure. Maintain accurate documentation and ensure all compliance records are up to date to meet audit and legal requirements. Proactively mitigate risks that may result in claims or damages due to quality lapses in materials or processes. Certification & Audits Support the company s efforts to obtain and maintain ISO and other relevant quality certifications. Coordinate regular internal and external quality audits, ensuring timely renewal and compliance with certification standards. Key Requirements: Diploma or Bachelor's degree in Civil Engineering or a related field. 4 5 years of hands-on experience in quality control or quality assurance in the construction or real estate sector. Strong knowledge of material testing, concrete standards, and quality audit procedures. Familiarity with environmental and safety regulations relevant to the construction industry. Proficiency in MS Office and documentation tools; ability to generate reports and maintain digital records. Excellent communication, coordination, and problem-solving skills. Qualification : Diploma or Bachelor's degree in Civil Engineering or a related field

Senior Compliance Specialist Location: Mumbai Industry: IT Services Department: Accounts & Finance Experience: 4 5 years About the Role Vertoz is seeking a Senior Compliance Specialist with in-depth knowledge of both Indian and U.S. compliance frameworks. This role is crucial to ensuring that our organization adheres to all statutory regulations and best practices in our global operations. About Vertoz Vertoz (NSEI: VERTOZ) is a cutting-edge AI-powered MadTech & CloudTech platform offering solutions in Digital Advertising, Marketing, Monetization, Digital Identity, and Cloud Infrastructure. We serve a diverse clientele, including businesses, digital marketers, advertising agencies, cloud providers, and publishers. Key Responsibilities India Statutory Compliance Ensure timely filing and payment of GST, TDS, Income Tax, and ROC/MCA filings. Keep systems and records aligned with current Indian regulatory updates. Ensure compliance with Indian labor laws (PF, ESI, PT, Gratuity, Shops & Establishments Act, etc.). Liaise with government departments (EPFO, ESIC, GST, IT) during audits, assessments, and inspections. U.S. Statutory Compliance Ensure adherence to U.S. federal, state, and local employment and tax regulations. Handle statutory filings such as W-2, W-9, 1099, Social Security, and Medicare. Manage state tax ID registrations/renewals and unemployment insurance filings. Collaborate with U.S. accounting/legal teams for IRS and franchise tax filings. Support audits and compliance reviews at the federal and state levels. General Compliance Oversight Maintain a detailed compliance calendar to meet all filing deadlines. Support internal and external audits with proper documentation. Draft and implement compliance SOPs to improve internal controls. Stay up to date with legal and regulatory changes in India and the U.S. and recommend relevant updates. Maintain secure and organized records of all compliance documents. Required Qualifications Bachelor s or Master s degree in Commerce, Finance, or Accounting. Preferred: Inter CA, CMA, or specialization in International Taxation. 3 5 years of experience in Indian compliance (PF, ESI, TDS, GST, ROC, etc.). 1 2 years of experience in U.S. compliance (IRS filings, payroll taxes, W-2, 1099, etc.). Experience with audits, inspections, and statutory filings in India and the U.S. Prior exposure to multinational or shared services environments is a plus. Proficient in tools like Oracle, SAP, Tally, Zoho Books, and ADP. Familiarity with statutory portals such as MCA, GSTN, and IRS. Perks & Benefits No dress code Flexible working hours 5-day work week 24 annual paid leaves International work exposure Regular team celebrations & outings Qualification : Bachelors or Masters degree in Commerce, Finance, or Accounting

Position: Executive Accounts Payable Department: Finance & Accounts Division: Corporate Location: Mumbai Experience: 2 3 years Qualification: B.Com / M.Com Job Purpose To manage daily accounts payable operations, ensure accurate invoice processing, tax compliance, and assist in maintaining financial records and reconciliations. The role supports smooth financial operations and adherence to internal controls and statutory regulations. Key Responsibilities Process all vendor invoices and payments on a daily basis, ensuring accuracy and completeness. Ensure compliance with statutory requirements such as Service Tax, TDS, and other applicable tax norms. Review purchase and accounts payable transactions for accuracy and appropriateness. Manage day-to-day petty cash transactions, including reconciliation and documentation. Support direct tax return filings and assist with other statutory submissions. Assist senior team members in preparing balance sheets and financial statements. Enter and verify financial data, including input of correct codes into the accounting system. Maintain up-to-date and accurate records of all payments, invoices, requisitions, and related correspondence. Prepare and reconcile bank statements on a regular basis. Maintain and process payroll records for staff and seafarers, including salary master updates. Verify and process site allowances based on Daily Progress Reports (DPRs). Handle data entry, record keeping, and systematic filing of all accounting vouchers. Maintain records and handle transactions related to COMACOE Dubai and Mauritius accounts. Ensure adherence to ISO systems and compliance procedures across all activities. Preferred Candidate Profile Bachelor's or Master s degree in Commerce (B.Com / M.Com). 2 3 years of relevant experience in Accounts Payable or general accounting. Proficient in MS Excel, accounting software (e.g., Tally, ERP systems), and reconciliations. Strong attention to detail with a high level of accuracy in data entry and financial documentation. Knowledge of Indian taxation (TDS, Service Tax) and basic payroll processes. Good communication and organizational skills. Ability to manage multiple priorities and meet deadlines under pressure. Familiarity with ISO procedures and compliance frameworks is an advantage.

Position: Engineer Procurement Department: Supply Chain Management (SCM) Division: Corporate Location: Mumbai Experience: 2 4 years Qualification: B.E. in Mechanical / Electrical / Civil Engineering Job Purpose To manage end-to-end procurement activities including purchasing, vendor management, logistics coordination, stores management, and inventory control. The role involves ensuring timely availability of materials and services, maintaining cost efficiency, and adhering to organizational policies and compliance standards. Key Responsibilities Procurement Operations: Handle complete procurement lifecycle: from raising enquiries, quotation analysis, technical/commercial evaluation, vendor finalization, negotiation, and issuing purchase orders (POs). Streamline and manage procurement processes for raw materials, engineering goods, consumables, chemicals, spares, packaging materials, capital goods, etc. Ensure timely procurement of materials and services as per project schedules. Maintain updated procurement records, including vendor documentation, purchase history, and price trends. Review and follow up on stock levels to maintain optimal inventory. Conduct regular market research to identify alternative suppliers, materials, and cost-saving opportunities. Vendor & Supplier Management: Build and maintain strong supplier/contractor relationships to ensure smooth and transparent business transactions. Continuously assess vendor performance on delivery, cost, and quality parameters. Lead vendor development initiatives to onboard capable suppliers in line with project and quality requirements. Obtain feedback on supplied goods/services and resolve any discrepancies through corrective or preventive measures. Logistics & Stores Coordination: Oversee logistics for inbound and outbound material movement (domestic and international), including all import/export documentation and statutory requirements. Coordinate inter/intra-state and international shipments to ensure timely delivery. Support stores and warehouse teams for efficient inventory management, material retrieval, and proper storage mechanisms. Cost & Compliance: Drive cost optimization through strategic sourcing, negotiation, and alternative procurement methods. Ensure procurement operations align with ISO compliance and internal control standards. Collaborate with compliance teams to generate and track all reports related to POs and procurement processes. Actively participate in the procurement budgeting process and contribute to cost tracking and forecasting. Cross-Functional Collaboration: Coordinate with project, engineering, and other internal departments to assess material requirements and specifications. Attend and conduct negotiation and project discussion meetings with cross-functional stakeholders. Team & Performance Management: Set goals for subordinates and monitor performance regularly. Mentor and guide team members for professional development and process improvement. Promote a collaborative, efficient, and accountable team culture. Preferred Candidate Profile Bachelor s degree in Mechanical, Electrical, or Civil Engineering. 2 4 years of experience in procurement, supply chain, or sourcing roles, preferably in a project-based or engineering organization. Solid understanding of supply chain processes, vendor management, inventory control, and logistics. Excellent negotiation, analytical, and communication skills. Proficiency in MS Office, ERP systems, and procurement software. Knowledge of Indian taxation, import/export processes, and ISO standards. Strong attention to detail, time management, and problem-solving ability. Qualification : B.E. in Mechanical / Electrical / Civil Engineering

Position: Technical Buyer Vessel Procurement Department: Supply Chain Management (SCM) Division: Corporate Location: Mumbai Experience: 7 9 years Qualification: Diploma in Mechanical / Civil Engineering or Graduate in Commerce Job Purpose To manage procurement operations specific to marine assets including tugs, barges, and support vessels by ensuring timely sourcing of spares, consumables, capital items, and services to support uninterrupted vessel operations across various projects. Key Responsibilities Procurement Operations Process material requisitions and indents received from vessels, ensuring timely procurement of all required items. Procure capital equipment, spares, inventory items, consumables, and marine-specific services for vessels across projects. Float RFQs, evaluate technical and commercial proposals, finalize vendors, and issue purchase orders. Ensure timely material delivery through regular follow-ups with suppliers and logistics partners. Vendor Management Develop and maintain a strong network of reliable suppliers, vendors, and contractors in the marine domain. Conduct performance assessments of vendors based on delivery, quality, and service levels. Negotiate terms and prices to drive cost savings without compromising quality or timelines. Identify and implement alternative sourcing options for critical items. Cross-Functional Collaboration Coordinate closely with vessel teams, owners, and internal stakeholders to understand technical specifications and procurement requirements. Share daily material status updates with indentors and vessel managers. Resolve material discrepancies or vendor issues promptly to minimize operational downtime. Process Improvement & Compliance Ensure adherence to company procurement policies and marine procurement best practices. Monitor and continuously improve procurement processes for efficiency and transparency. Maintain all procurement documentation and records as per audit and ISO compliance requirements. Preferred Candidate Profile Diploma in Mechanical or Civil Engineering, or Graduate in Commerce. 7 9 years of relevant procurement experience, preferably in marine, offshore, shipping, or EPC industries. Strong understanding of vessel operations, marine spares, consumables, and equipment. Excellent negotiation, vendor development, and communication skills. Ability to coordinate effectively with cross-functional and vessel-based teams. Familiarity with procurement software, ERP systems, and MS Office tools. Qualification : Diploma in Mechanical / Civil Engineering or Graduate in Commerce

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.

Job Description As a Knowledge Content Manager Associate in our team, you will be at the forefront of managing and enhancing our content database, ensuring that our sales materials (including RFPs, pitch books, and brochures) are compelling, accurate, and globally-consistent. You will collaborate with sales, product, client service, and other subject matter experts to ensure content and stats are accurate, consistent, and approved. You will also create materials for sales training, such as case studies, information on product overviews and strategy, and prepare competitor analysis. Job Responsibilities: Maintain, update, and enhance content used for client-facing documentation (proposals, pitchbooks, and other similar documents) provided to prospective and existing clients in pursuit of winning or retaining business. Develop external and internal content in partnership with sales and product, including case studies, and product overviews & strategy documents. Coordinate with subject matter experts to update the database with new responses as products are enhanced. Partner with subject matter experts to conduct periodic end-to-end reviews of responses in the database to ensure changes in business, value proposition, regulatory environment, staff, locations, etc., are correctly captured. Utilize Tableau to build dynamic data visualization dashboards, transforming complex data into actionable insights that support strategic sales initiatives. Source and manage J.P. Morgan statistics in the creation of sales documents or in answering questions from clients or prospects globally. Manage the sales experience survey process as the conduit between sales and the third-party consultant. Perform vendor administration activities such as user access management and training, and act as a point of contact, liaising with vendor support to quickly resolve issues. Required Qualifications, Capabilities, and Skills: Minimum 4 years of work experience in the financial services industry, within content/database management, pre-sales, business development, or marketing. Excellent verbal and written communication skills, with a thorough knowledge of American and British English language, grammar, spelling, punctuation, and usage, as well as the Associated Press (AP) style guide. Confidence, assertiveness, and professionalism to partner closely with all levels of management. Proficiency with MS Word, Excel, and PowerPoint required. Strong project management skills with the ability to manage tight schedules. Preferred Qualifications, Capabilities, and Skills: Bachelor's degree (BA or BS) in finance, business preferred, but not required. An understanding of the securities services industry and products is a plus. Self-starter with sound judgment and ability to operate independently and apply initiative. Experience with building data visualization dashboards via Tableau. Familiarity with emerging technologies, such as LLMs to bring in efficiencies in content and stats management. About Us JPMorgan Chase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses, and many of the world s most prominent corporate, institutional, and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years, and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing, and asset management. Qualification : Bachelor's degree (BA or BS) in finance, business preferred, but not required.

Job Description: We are seeking a highly skilled and motivated Business Analyst to join our team. In this role, you will work closely with stakeholders to define, document, and optimize business processes. You will play a key part in ensuring that systems are designed according to user needs, conducting functional testing, and assisting with user acceptance testing. Additionally, you will support the team with training, business process evaluations, and process optimization strategies. Your efforts will help drive continuous improvement and ensure timely delivery of projects. Key Responsibilities: Define and document customer business functions and processes. Identify, define, and document business needs and objectives, ensuring that the system design aligns with user requirements. Prepare functional test cases to ensure that the developed system meets user needs. Participate in user acceptance testing and conduct functionality testing of new systems. Assist in training and coaching both professional and technical staff to improve their skill sets. Evaluate business processes, anticipate requirements, and uncover areas for improvement. Develop and implement solutions to enhance business processes and optimize systems. Lead ongoing reviews of business processes and develop strategies to optimize them. Stay up-to-date with the latest process and IT advancements to help modernize and automate systems. Conduct meetings and presentations to share ideas and findings with stakeholders. Document and communicate the results of your efforts to ensure clarity and alignment with project goals. Gather critical information from meetings with stakeholders and produce useful reports. Manage projects, develop project plans, and monitor the performance of ongoing projects. Ensure timely completion of deliverables and track progress against deadlines. Required Technology Stack: Ability to conduct and manage stakeholder meetings effectively. Strong stakeholder management skills, ensuring clear communication and alignment. Proficiency in SQL query writing. Strong documentation and writing skills. Good presentation skills, capable of presenting ideas and findings clearly. Experience with data modeling and analyzing both Microsoft and Open-source applications for testing and analysis. Expertise in writing and analyzing SQL stored procedures. Experience interacting with customers for gathering requirements, QA, and issue analysis. Domain Exposure: Familiarity with Depository Participants or Insurance domains will be a plus. Educational Requirements: B.E. (Computers/IT), MSc, MCA or a related field. Technical and Professional Requirements: Strong knowledge of data modeling. Experience with both Microsoft and open-source applications for testing/analysis. This is a fantastic opportunity for a skilled Business Analyst to play an important role in optimizing and modernizing business processes, working across teams, and ensuring the success of key projects. If you are driven, organized, and passionate about process improvement, we encourage you to apply! Qualification : B.E. (Computers/IT), MSc, MCA

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.

Description We re a top-ranked engineering and construction firm where employee ownership is more than a phrase, it s the foundation of our culture. Our Mumbai office supports major projects worldwide, and our team members thrive in a setting that encourages learning, leadership, and personal growth. You ll have access to international travel opportunities, advanced technical training, and the chance to collaborate with accomplished specialists on large projects in renewables, refining, petrochemical, midstream, and logistics. With a proven track record of delivering complex solutions, our department is recognized for its maturity and expertise.We also prioritize a flexible work schedule and collectively cultivate a supportive and engaging work environment where every voice matters. Role Summary Assistant Document Controller position responsible for efficient document management, ensuring accurate processing and control of project documentation while maintaining high standards of organization and timely delivery. Key Responsibilities: Process engineering and vendor documents with timely transmittal to clients Perform bulk document uploads to EDMS using spreadsheets Distribute project documents to internal teams per DDM requirements Coordinate with BMUS counterpart and discipline teams on document control queries Generate project-specific reports as required Track and monitor engineering and supplier documents/drawings Handle internal and external document requests Manage vendor documentation processes Compile technical specifications Maintain confidential document security Follow safety protocols and norms Support document control system maintenance Process incoming and outgoing project documentation Update document registers and logs What Makes You a Great Fit Skilled at leadership and communication, with the ability to build strong professional relationships Keen awareness of ethical/code responsibilities; always acts in the company s best interests Self-starter who adapts quickly to evolving circumstances Embraces our employee ownership culture and champions diversity and inclusivity Enthusiasm about our bonus-incentive-based compensation model that rewards top performance designed for those committed to building a long-term career in an employee ownership culture Values a supportive, engaging workplace where every individual s input is encouraged and respected Qualifications Any Graduate Preferably Commerce / Library / Data Science 0-1 year document control experience Proven experience in document management systems Strong technical documentation background Proficient English communication skills Qualification : Any Graduate Preferably Commerce / Library / Data Science

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

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).

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...