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Division Legal Department Legal Employment Type Permanent Job Purpose Drive compliance program for global corporate, sales and marketing and manufacturing units ( Covered Units ) of the company and legal strategy and administration of the areas as per business requirement. Provide legal assistance to address any compliance related contingencies that may arise during day-to-day business activities to ensure smooth and uninterrupted flow of business operations. Drive the legal strategy for generics - branded/unbranded, brand and 505(b)(2) business including promotional reviews. Administer, train, monitor and initiate remediation on the global compliance tool. Accountabilities 1. Heatlhcare and Corporate Compliance Establish healthcare and corporate compliance program Provide timely, competent and practical advice and support regarding compliance. Review and approval of global Cipla materials/communications to ensure compliance with applicable legal and regulatory requirements. Liaise with internal stakeholders in all compliance related activities. Establish compliance training on key legal aspects of the legal framework of the global federal/central state and local laws, auditing and monitoring programs, including support of enterprise risk management. Facilitate compliance with state/region-specific legal requirements and local sales credentialing requirements Ensure preparation and management of applicable state marketing/transparency reports Develop or revise compliance policies, documents, deliverables and training Oversee investigations and response to internal or external enforcement actions Take full ownership for the tool-based total compliance program implementation and compliance certification for the Covered Units Accountabilities 2. Business Development and Strategic Initiatives Support strategic initiatives as member of Senior Leadership Team Lead Government Affairs efforts, as and when required, in collaboration with various businesses/ functions Support evaluation of business development opportunities Support due diligence and integration activities Ensure proper and comprehensive execution of strategic and business development imperatives Collaborate on trademarks, copyrights, design, and patents prosecution, protection and estate management and assist on patent challenge initiatives. Provide advice on legal issues in M&A, high-value negotiations, BD&IL work, in coordination with the Global General Counsel Accountabilities 3. Legal advice on US and other global markets branded, therapeutics, government business and other businesses and 505(b)(2) products, including promotional reviews Implement legal and litigation strategy, policies, procedures, and systems for the branded, therapeutics, Exelan and other businesses as required. Review promotional and educational materials, participate as a member of the promotional review committee (PRC), and provide legal advice and solutions to marketing, regulatory and medical teams on advertising and promotional materials and regulations - for the Branded, 505(b)(2) and Gx products (as applicable). Advice legal commercial businesses and operations in support of approved and pipeline products in the branded space, including working with Medical Affairs, Sales, Marketing, Market Access, Regulatory and others to ensure success. Draft, negotiate, review and advise on various agreements, including consulting agreements, master service agreements, supply agreements, distribution agreements, advisory agreements, market access-related agreements (including: PBM, Payer, and GPO agreements), wholesaler agreements, discount and rebate agreements Provide advice in relation to the company s interactions with HCPs and HCP consulting, HCP speaker programs and agreements. Provide legal guidance on patient support programs, and specialty pharmacy and HUB pharmacy collaborations. Enhancing legal understanding/capability of teams with training on key legal aspects of the legal framework of the US Provide legal, medical, regulatory requirements and review process for the branded business, including evaluating these aspects for various business models, structures, new/ amended laws, rules, and regulations to be followed Accountabilities 4. Compliance to Trade Agreement Act (TAA) for the applicable business(es) TAA compliance for all businesses engaged as contractor with federal government to avoid potential legal issues and financial consequences and or fines under the False Claims Act (FCA). Due diligence for TAA compliance including identification of contracts subject to TAA, Product Origin Assessment etc. Maintain a record of all due diligence activities, including assessments, reviews, certifications, and written supplier certifications Conduct internal training to educate employees about TAA requirements and the importance of compliance. Engage with legal counsel experienced in government contracts and TAA compliance to ensure accurate interpretation and implementation of TAA regulations Accountabilities 5. Drive corporate separateness across legal entities Ensure legal corporate separateness across various legal entities - Exelan, Cipla USA, Therapeutics and InvaGen etc.. Manage relevant compliances and legal advisory. Conduct internal training to educate employees about corporate separateness. Draft, negotiate, review and advise on various contracts, agreements, including pricing/GTN/ rebate etc., consulting agreements, master service agreements, supply agreements, distribution agreements, advisory agreements for various entities as per business requirements. 6. Other statutory license compliances Manage pharma distribution licenses across all entities Draft, negotiate, review and advise on various agreements related to distribution licenses Education Qualification Baccalaureate level law degree in a relevant area from an accredited university required. 5+ years healthcare experience in the pharmaceutical or medical device industry & overall 15 years of PQE. Demonstrated knowledge and understanding of the required elements of compliance programs and applicable industry standards. Awareness of fraud and abuse laws and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry cooperative groups including global FDAs. Knowledge of people management including recruitment, hiring, progressive discipline process and coaching. Certification in Compliance & Ethics and Information Privacy from an accredited organization preferred Relevant Work Experience Exceptional communication and collaboration skills, including presentation capabilities, interpersonal skills and conflict resolution. Action-oriented team player. Ability to work independently and with a high level of initiative. Ability to summarize and simplify complex information. Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organization. Must be able to manage complex projects and multiple projects simultaneously. Demonstrated ability to adapt to and lead through changing competitive challenges and market dynamics. Displays a sense of urgency and commitment to achievement of objectives and commitment. Competencies/Skills Collaborate to Succeed Innovate to Excel Perform with Accountability Lead with Empathy Act with Agility Strong Domain Knowledge People Management Job Location Lower Parel Shift Hours

Summary -Senior Specialist for project delivery and/or operations in the given business sub-capability. Partner with Business Stakeholders and TT Strategic Business Partners for demand analysis, solution proposal/evaluation and project delivery. About the Role Position Title: Associate Director, MDM Solution Delivery Location - Hyd-India# LI Hybrid Role Purpose Building relationships with millions of customers around the world requires effective management of customer profiles from across the enterprise. Analyzing performance requires alignment of Brand data across multiple systems and data sources. Multi-domain Master Data Management (MDM) ensures that our data-intensive applications, analytics, and AI are built upon a solid foundation. In this role, you will lead the design and development of integrations from our master data management platforms to our data mesh and other applications. You will work with state-of-the-art tools like Reltio, Snowflake, Collibra, Atacama, and AWS services. Your responsibilities include but are not limited to Define and lead integration development for commercial master data management products, focusing on use of appropriate MDM styles and efficient interoperability Work with solution and enterprise architects to find the best tools and design patterns for master data management solutions Evangelize the use of master data in other applications across the technology landscape Work with business and technical product owners to build the solution roadmap Collaborate with commercial product leads, data scientists, CRM architects, and omnichannel strategists to align business goals with data needs and technical feasibility Collaborate with a team of talented technologists to deliver scalable solutions Proactively identify potential gaps in the technology and data landscape and propose new solutions Follow industry trends and emerging practices to drive agility, speed, efficiency, and effectiveness Ensure alignment to security and compliance policies and procedures What you ll bring to the role: Experience working with agile development teams using a proven methodology (e. g. , scrum) Strong understanding of master data management, including an understanding of the MDM styles and when to use them Advanced understanding of master data management solutions (e. g. , Reltio) Strong technical fluency in data integration principles and cloud technologies] e. g. , AWS services) and familiarity with data mesh principles Experience with commercial pharma data and relationships between entities Experience working effectively with multiple complex projects in a matrix organization Exceptional communication and stakeholder engagement skills, with the ability to present design rationale to cross-functional teams and senior leadership Desirable Requirements: Bachelor s or master s degree in computer science, Engineering, Business, or related field. 9+ years of experience in data management and/or software development using cloud technologies A proven track record of designing integrations for sales, marketing, CRM, or omnichannel platforms A proven track record of designing data publishing interfaces for consumption in a data mesh Familiarity with common global pharmaceutical data sources (e. g. , OneKey, Ampco, Medidata, Midas, OpenData) Familiarity with common pharmaceutical applications, including CRM Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Summary The Salesforce Data Cloud Analyst will play a crucial role in leveraging Salesforce Data Cloud to transform how our organization uses customer data. This position sits within the Data Cloud Business Enablement Team and focuses on building, managing, and optimizing our data unification strategy to power business intelligence, marketing automation, and customer experience initiatives About the Role Location - Hyderabad About the role: The Salesforce Data Cloud Analyst will play a crucial role in leveraging Salesforce Data Cloud to transform how our organization uses customer data. This position sits within the Data Cloud Business Enablement Team and focuses on building, managing, and optimizing our data unification strategy to power business intelligence, marketing automation, and customer experience initiatives Key Responsibilities: Manage data models within Salesforce Data Cloud, ensuring optimal data harmonization across multiple sources Maintain data streams from various platforms into Data Cloud, including CRM, SFMC, MCP, Snowflake and third-party applications Develop and optimize SQL queries to transform raw data into actionable insights Build and maintain data tables, calculated insights, and segments for use across the organization Collaborate with marketing teams to translate business requirements into effective data solutions Monitor data quality and implement processes to ensure accuracy and reliability Create documentation for data models, processes, and best practices Provide training and support to business users on leveraging Data Cloud capabilities Essential Requirements: Advanced knowledge of Salesforce Data Cloud architecture and capabilities Strong SQL skills for data transformation and query optimization Experience with ETL processes and data integration patterns Understanding of data modeling principles and best practices Experience with Salesforce Marketing Cloud, MCI & MCP Familiarity with APIs and data integration techniques Knowledge of data privacy regulations and compliance requirements (GDPR, CCPA, etc. ) Bachelors degree in Computer Science, Information Systems, or related field 3+ years experience working with Salesforce platforms Salesforce Data Cloud certification preferred Demonstrated experience with data analysis and business intelligence tools Strong problem-solving abilities and analytical thinking Excellent communication skills to translate technical concepts to business users Ability to work collaboratively in cross-functional teams Experience working in regulated industries like pharma is a plus Preferred Requirements: Previous work with Customer Data Platforms (CDPs) Experience with Tableau CRM or other visualization tools Background in marketing technology or customer experience initiatives Salesforce Administrator or Developer certification Familiarity with Agile ways of working, Jira, and Confluence This role offers the opportunity to shape how our organization leverages customer data to drive meaningful business outcomes and exceptional customer experiences. Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl. india@novartis. com and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Create SAS programs to generate derived analysis data sets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis d atasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and revi e w Reviews key planning documents (e. g. , statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programmi ng assumptions and requirements ; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming spec ifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences ( GB D S) deliverables by consistently applying s tandards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work p ractices Identifies opportunities for increased efficiency and consistency within GB D S and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required . At least 5 years programming experience in industry recommended . For US positions: US military experience will be considered towards industry experience . Demonstrated proficiency in using SAS , R or other programming languages to produce deriv ed analysis datasets and TFLs. Have in -depth understanding of clinical data structure ( e. g. CD I SC standards) and relational database. Demonstrated skills in using software tools and applications, e. g. , MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e. g. , multiple d ata forms, workflow, eDC , SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e. g. , ADaM , Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environm ent with clinical team members. Preferred Requirements : Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings ( e. g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology , statistics and familiarity with global regulatory requirements Experience in other software packages ( e. g. R) Experience with the Linux operating system If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

As a Manager in the Customer Success team at McKesson Compile, the individual will lead strategic client engagements, ensure successful onboarding and adoption of our data solutions, and drive measurable outcomes for our healthcare and life sciences clients. The individual will collaborate closely with cross-functional teams including Product, Engineering, and Data Operations to deliver exceptional service and value. The individual will be responsible for ensuring that our partners receive the highest level of service and support. This role requires a strategic thinker with a strong background in healthcare data, project management, and customer service. Key Responsibilities Collaborate with strategy, business development, and RWD Analytics teams to support other McKesson business units optimizing and improving their businesses Serve as the key point of contact for customers, building strong relationships and ensuring their needs are met Lead end to end customer lifecycle engagements, ensuring smooth onboarding, training, and ongoing support for clients. Translate customer feedback into actionable insights for product and engineering teams. Track and report on customer health metrics, usage trends, and renewal risks. Drive continuous improvement in CS processes and documentation. Ensure strong written and oral communication, particularly in explaining technical concepts to non-technical users Manage and mentor a small team (Senior Associate and Associate), fostering a high-performance culture. Establish and maintain clear goals and performance metrics for the team, regularly reviewing progress and adjusting as needed With a lens on customer experience, look to improve & innovate across the functions and processes Collaboration and meetings across U.S. and India time zone, typically working overlap during the US mornings. Qualifications: Minimum Requirements: 5+ years of experience in Customer Success, Account Management, or related roles in healthcare, pharma, or data analytics. Strong communication and stakeholder management skills. Hands on Experience working with healthcare data (claims, provider, patient-level data). Excellent written and oral communication skills, with the ability to explain technical concepts to non-technical users Demonstrated ability to manage complex projects and deliver results on time and within budget In-depth knowledge of healthcare data and analytics, with experience using data to solve business problems. Critical Skills Ability to query data with SQL and apply it to common life sciences applications and use cases Ability to build customer presentation decks that translate the data visually aligned to the customer/project request Deep attention to detail, adherence to process and organization Deep working knowledge of commercial Life Sciences data products (claims, EHR, provider reference data, HCP affiliations, HCO hierarchy, etc.) Deep working knowledge of biopharma commercial and RWE use cases and how commercial Life Sciences data is best applied Willingness and enthusiasm to collaborate and unify teams and work streams between India and the US Technical Skills: Proficiency and expertise in the below tools are key to succeed in this role: Customer management and project management software and tools (e.g., Hub Spot, Microsoft Project, JIRA, Confluence, etc.). SQL, python, and familiarity and proven experience in data analytics and analysis Microsoft Suite: Power point, Excel, Outlook Insight and experience in data transferring through Snowflake, Data Bricks, and other modalities Familiarity with regulatory requirements related to healthcare data (e.g., HIPAA)

CORE JOB RESPONSIBILITIES 1. To analyse and prepare working plan for the territory basis the data provides/ market research 2. To be able to follow up, monitor and achieve targets of the territory 3. Implementation & execution of all strategies 4. Stakeholder engagement- doctors, stockist, retailers, chemists and institutions pharmacy 5. Discipline and punctual with set timelines for multiple internal processes 7. Basic computer skills- excel working, word & email exchanges 6. Fast learner and adaptable to change in market 7. Strong communication skills (verbal)- English and local language 8. Effective in-clinic performance 9. Basic understanding and ability to explain anatomy physiology and product portfoli0 10. Organizing Camps (CME) as per the division strategy and customer needs 11. Prescription audit for Abbott brands and other competitors brands 12. Generate POBs for Abbott brands as per the business plan REQUIRED EXPERIENCE Experience 2+ years of experience Fresher with good communication skills and analytical skills may also consider Required Qualification B.Sc. / B.Pharma. LOCATION: India > Mumbai : Unit 3 Corporate Park t

Primary Job Function Achieving assigned territory/ geography wise sales target Carrying out effective field work without direct day-to-day supervision Report field work in daily basis on assigned online system Meeting Call Average, Coverage, Frequency coverage Norms of assigned division Core Job Responsibilities Generate maximum prescriptions & increase market share Promote the Division s products as per strategy Relationship Building with the Stake holders (Doctors, Chemists, Stockiest etc) Facilitating Strategy building A good Brand Ambassador Minimum Education BSc/B. Pharma. Experience/Training Required 2+ Yrs of experience Fresher with good communication and analytical skill may also consider Candidate with prior/current experience in same therapy. Candidate from MNC and top Indian Pharma companies will have added advantage. Fluent and confident in communication LOCATION: India > Hyderabad : No 1-6-140 t

Summarize the main purpose of the role. Conduct market research and feasibility studies to analyze the viability of alternative business development opportunities. MAIN RESPONSIBILITIES Collect, compile, verify, and analyze financial, competitive, sales, marketing, and other information about potential business partners, new markets, products and services, or other business opportunities so that senior management has accurate and timely information for making strategic and operational decisions. Prepare documents and materials (for example, reports, presentations, information packages) for meetings and negotiations with potential clients and business partners so that the information provided is accurate and appropriate for external distribution. QUALIFICATIONS Education Education Level Major/Field of Study Or Education Level Associates Degree ( 13 years) Experience/Background Experience Experience Details No Experience

YOUR TASKS AND RESPONSIBILITIES: Preparation & Review of start-up Documents: eCRF completion Guidelines, DMP, SAE reconciliation plan, Clinical Coding Plan Preparation of Edit specification document (ESD), Test Plan and Data Entry Guideline Screen design UAT Edit checks UAT in CDMS as per ESD Discrepancy Management Support Data Manager in URS review for IWRS Ensure timely completion of SAE reconciliation activities Ensure timely completion of closeout activities including database lock Preparation and update of Master Data Management File to ensure its completeness Preparation & Review of Data Management Report WHO YOU ARE: Pharmacy / Science Post-Graduate At least 5 years of experience in the clinical data management domain in Pharma/CRO industry. Experience in, development of data management documents, development of validation plan, screen UAT, edit check UAT, clinical data query management etc. Job Location: Remote working job opportunity

YOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures. Systems and Processes: Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations. Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department. To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed. To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness. Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements. Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols. Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team. Assess and identify the training requirement of study team and ensure completion of training. Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability. Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed. Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement. Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7. Ensure periodic review of Vendors and renewals as per applicable policies & procedures. Identify and recommend process improvement initiatives where required. Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets. Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices. Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team. Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement. Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites. Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents. Review and communication of QC findings to respective department in stipulated timelines. Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required. Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis. Ensure training of SOPs, on job training and reviewing training files on regular basis. QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans. Ensure record maintenance for all activities for traceability in line with regulatory requirement. WHO YOU ARE: > 5 years experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department. Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills. Must have experience in handling audits & inspections of DCGI, US FDA. Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials. Experience of working in matrix business environments preferred. Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. Quality oriented mindset and skill set. Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA). In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research. Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements. Have strong analytical and problem-solving skills and the ability to present solutions. Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization. Eye for details, Sense of urgency & desire to excel. Proficiency with Excel or other quality management systems/ tools. Result oriented and performance driven. Excellent interpersonal & communication skills to effectively interact with a broad range of audience. Job location: Sun House, Goregaon East, Mumbai

About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: To assist pharma regulatory team of Syngene in executing submissions for various licensing activities and follow up with regulators to ensure timely approvals. Role Accountabilities: Preparation and submission of CT-10, CT-12, CT-13, CT-16, Form 12 applications to CDSCO (biological and small molecules), Export NOC, Form 29, GMP, WHO-GMP, license retention, Form 37, COPP, WC and endorsement applications to CDSCO and SLA as applicable. Respond to regulator s queries by collaborating with internal and external stakeholders. Follow-ups for approvals with CDSCO, Zone, SLA and NCB. Filling quarterly returns to NCB and maintain compliance to RCS, 2013. Supporting the team in preparation of IBSC and RCGM application, coordinate and convene IBSC meetings on behalf of member secretary, IBSC. Providing consultation to the internal stakeholders and clients regarding national regulatory requirements as and when required. Maintenance of all submissions and approvals record by maintaining database and trackers. Manufacturing licenses (R&D and commercial), import and export permissions, liaising with State regulators. Providing time to time update to the stakeholders on the licenses and participating in teleconferences/ discussions with stakeholders / clients as required. Prepare new SOPs as and when required, update current SOPs periodically. Keep all operating units updated on recent change in rules and regulations governing product development life cycle. Leadership Capabilities: Maintain a culture of collaboration and team building in the department. Foster behavior for continuous learning and development Clear and precise communication while collaborating with stakeholders. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: 6-8 years Demonstrated Capability: Able to make error free submissions and ensure timely approvals. Attention to detail Time management Education: M.Pharma/M.Sc./equivalent Skills and Capabilities 1. Excellent analytical & reasoning skills 2. Good communication (verbal and written) skills 3. Proactiveness and good time management skills 4. Sound working knowledge of national pharma regulatory affairs landscape.

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form PURPOSE AND SCOPE: Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. In addition to publishing responsibilities, this role will lead and support the creation, implementation, and ongoing maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes, ensuring alignment with evolving regulatory requirements, internal standards, and best practices. . PRINCIPAL DUTIES AND RESPONSIBILITIES: Serves as a seasoned regulatory operations professional with a comprehensive understanding of global submission requirements and processes; applies creative problem-solving to resolve a wide range of technical and operational issues. Manages the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements and internal standards. Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions (e.g., supplements, variations, renewals) across multiple regions including the U.S., Canada, EU, and Asia-Pacific. Performs thorough QC reviews to ensure submission-ready documents meet formatting, technical, and regulatory standards. Collaborates cross-functionally with Regulatory Affairs, CMC, Medical Writing, Quality, and other stakeholders to ensure timely and accurate handoff of components for inclusion in submissions. Interprets and applies key regulatory guidance, regional submission specifications, and evolving eCTD requirements (including ICH, FDA, EMA, etc.). Leads and contributes to the development, revision, implementation, and training of departmental SOPs, WIs, and standardized publishing processes to ensure consistency, efficiency, and regulatory compliance. Assists in the management and continuous improvement of templates, procedures, and tools used to support global submission activities. Troubleshoots technical issues related to publishing tools and document formatting, particularly within MS Word and Adobe Acrobat, and supports resolution of validation errors. Participates in evaluating and implementing new regulatory technologies; ensures alignment with infrastructure standards and supports transitions from legacy systems to electronic platforms. Maintains compliant archival and storage of regulatory documents, ensuring alignment with regulatory and business needs. May mentor junior staff, provide publishing guidance, and act as a resource for complex submissions. Demonstrates strong organizational and time management skills with the ability to manage multiple priorities under tight deadlines. Ensures compliance with all applicable regulations, company policies, and the Code of Business Conduct. May escalate complex issues for resolution and assist with additional projects or duties as assigned. Assist with various projects as assigned by a direct supervisor. Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function EXPERIENCE AND REQUIRED SKILLS : Bachelor s Degree required; Advanced Degree desirable Minimum five (5) years of regulatory operations experience in the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions. Proven expertise in the preparation, compilation, publishing, and validation of eCTD submissions in support of U.S. (FDA), Canada (Health Canada), EU (EMA, MHRA), and Asia-Pacific (PMDA, TGA, NMPA, etc.) regulatory requirements. In-depth knowledge of electronic publishing tools and Regulatory Information Management (RIM) systems. Proficiency with electronic document management systems (EDMS) and advanced knowledge of document formatting tools, particularly MS Word (template and style management) and Adobe Acrobat (PDF optimization and troubleshooting). Strong understanding of global regulatory submission guidance. Demonstrated experience managing multiple submission projects in parallel, with proven ability to meet tight deadlines and deliver high-quality, technically compliant outputs. Strong organizational skills and meticulous attention to detail; able to identify and resolve issues independently and proactively. Excellent written and verbal communication skills, with the ability to clearly document processes, communicate submission requirements, and collaborate effectively across teams. Experience with electronic submissions, specifically eCTD, required. Strong understanding of document management processes in a regulated pharmaceutical environment. Demonstrated understanding of the drug development process and project management experience is highly preferred. Proven experience in developing, revising, and maintaining departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and internal processes, with a focus on continuous improvement and regulatory compliance. Strong software troubleshooting skills. EOE, disability/veterans

Position Summary: The Feasibility Manager is a member of the expert team within Feasibility Department of Precision for Medicine. As part of this team, this role has responsibility to support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Feasibility Manager supports pre-award feasibility projects and support business development and operational strategy teams by conducting feasibility analysis. The Feasibility Manager supports stand-alone feasibility projects and site identification and is providing feasibility support for newly awarded and/or ongoing projects. In addition, Feasibility Manager may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients. Essential functions of the job include but are not limited to: Support pre-award feasibility projects Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis. Review clinical protocols, study assumptions, client information and study plans for US and global trials. Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale. Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information. Undertake feasibility site outreach for pre award opportunities. Participate and/or contribute to BDM and client calls. Provide support to post-award feasibility projects Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements. Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery. Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies) Minimum required: Bachelor s degree in a life sciences discipline A minimum of 5 years of related experience Combination of qualifications and equivalent relevant experience may be accepted as an alternative. Other Required: Relevant experience in the required activities for the role including feasibility analysis, site identification. Ability to communicate both verbally and in writing at the English proficiently (Professional level) Preferred: Postgraduate degree preferred. Skills Strong management and organizational skills Excellent oral and written communication skills in English Strong rationale and analytical thinking Strong IT platform and data analysis skills Strong presentation abilities Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms Competencies Strong sense of ownership and pride in quality of outputs Good to strong attention to detail with ability to see the big picture Team player Willingness to work in a matrix environment, work independently and as part of a dynamic team. Demonstrates knowledge of ICH-GCP Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Job Description Position Summary: The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. Responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study. Essential functions of the job include but are not limited to: Support the Quality Management System including SOPs, training and CAPA Process and maintain documentation for controlled documents, as required Develop and administer training for employees and/or consultants Host client/sponsor audits and support regulatory inspections Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted Coordinate and conduct internal audits of quality systems Coordinate and conduct investigator site audits Coordinate and conduct trial master file audits Participate on computer systems validation projects and systems change control process Provide QA consultation and support to assigned project teams internally and externally Support and manage reported quality issues and any associated corrective and preventive actions Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement Maintains Q&C trackers, databases, metrics, and files Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures Additional tasks as required. Qualifications: Minimum Required: 4 years industry experience Clinical research experience in non-QA role considered (e.g., clinical research associate experience) Working knowledge of GCP/ICH guidelines and FDA regulations and standards. Other Required: Bachelor s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative Availability to travel up to 25% domestically and/or internationally. Preferred: CRO, Pharmaceutical and/or Medical device experience QA certification preferred (e.g., CQA, SQA, etc.) Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.) Skills: Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills Competencies Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards Intermediate proficiency in Microsoft Word, Excel, and PowerPoint Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail Ability to work independently and in a team environment Ability to work with cross functional groups and management under challenging situations Ability to prioritize work and handle multiple and/or competing assignments Results oriented, accountable, motivated and flexible Demonstrates values and a work ethic consistent with Precision Values and Company Principles. Excellent verbal and written communications skills Fluent in English language and for non English speaking countries, the local language of country where position is based Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Overview about Ripik.AI: Ripik.ai is a fast-growing industrial AI SAAS start-up founded by IIT D/ BITS alumni and with extensive experience in McKinsey, IBM, Google and others. It is backed by marquee VC funds like Accel, Venture Highway and 25+ illustrious angels including 14 unicorn founders. Ripik.ai builds patented full stack software for automation of decision making on the factory floor. Today, they are deployed at more than 15 of the largest and most prestigious enterprises in India including the market leaders in steel, aluminium, cement, pharma, paints, consumer goods and others. It is one of world s very few AI product start-ups to be a partner to GCP, Azure and AWS. We are also the AI partner of choice for CII, ICC and NASSCOM. Roles & Responsibilities: We are looking for a competent and driven DCS Engineer with 4-5 years of experience in Siemens S7- 400 and ABB DCS systems. The role demands hands-on expertise in project development, DCS configuration, system commissioning, and strong knowledge of OT/IT networking and OPC communication protocols. This position will support the execution of industrial automation projects across various process industries. Design, configure, and implement Distributed Control Systems using Siemens S7-400 (PCS7) and ABB DCS 800xA platforms. Develop and review functional and technical documentation (FDS, C&E, loop diagrams, I/O lists, etc.). Configure and integrate HMI/SCADA systems, logic programming, alarms, trends, and historians as required. Lead or support at all stages of the automation project lifecycle: design, development, testing (FAT/SAT), and on-site commissioning. Design and troubleshoot OT (Operational Technology) networks, including layered architectures, VLANs, and segregation between OT and IT zones. Implement and manage OPC (DA/UA/HDA) and other industrial protocols like Profibus, Profinet, Modbus TCP/RTU, Ethernet/IP for PLC-DCS or SCADA integrations. Collaborate with cross-functional teams including instrumentation, electrical, and IT networking teams. Conduct system diagnostics, performance tuning, and provide post-commissioning support. Ensure compliance with project specifications, industry standards, and cybersecurity best practices. Maintain accurate records, backups, and change logs for all DCS-related modifications. Required Skills, Competencies & Experience: Bachelor s Degree or Diploma in Instrumentation, Electronics, Electrical Engineering, or related field. 4-5 years of relevant experience working with: Siemens S7-400 / PCS7 DCS & ABB DCS (800xA Seires). Strong understanding of DCS and PLC architectures, field instrumentation, and process control concepts. Proficiency in industrial communication protocols, especially: OPC DA/UA/HAD, Profibus/Profinet Modbus TCP/RTU & Ethernet/IP. Hands-on experience with OT/IT network architectures, including firewall and switch configurations, IP addressing, and basic routing. Experience in integrating DCS with third-party systems, PLCs, and enterprise-level applications. Ability to work independently on-site during commissioning and troubleshoot control systems. Strong communication skills and a collaborative attitude. Preferred Qualification: Knowledge of cybersecurity in OT environments (ISA/IEC 62443 awareness). Familiarity with SCADA, Historian systems, or MES integration. Exposure to virtualization, server-client architecture, or redundant systems. Knowledge of video analytics, CCTV integration, and industrial automation security. Physical Requirements: Ability to travel to project sites and conduct field inspections. Comfortable working in hazardous industrial environments (oil refineries, chemical plants, etc.) What can you expect? Ability to shape the future of manufacturing by leveraging best-in-class AI and software; we are a unique organization with niche skill set that you would also develop while working with us World class work culture, coaching and development Mentoring from highly experienced leadership from world class companies (refer to Ripik.AI website for details) Location - Noida (Work from Office)

We are looking for an experienced and driven Manager PAS to lead the configuration, implementation, and validation of Scitara s DLX iPaaS platform. This is a customer-facing leadership role ideal for someone with deep expertise in lab informatics systems, a passion for technology in the pharma/life sciences domain, and a strong sense of ownership. You will be a key member of the Services organization, collaborating across product, engineering, and customer success teams to deliver high-impact solutions. Key Responsibilities Lead the implementation and validation of Scitara DLX iPaaS for global pharma and life sciences customers. Participate in customer calls, actively driving discovery, influencing solution design, and delivering value-oriented technical recommendations. Conduct effective product demonstrations and communicate the product s value proposition clearly. Leverage domain and technical expertise to guide the design of scalable, compliant, and robust solutions. Align delivery strategies and technical solutions with Scitara s broader business objectives. Collaborate cross-functionally with Product Managers, Solution Architects, and Software Engineers to ensure smooth handovers and cohesive customer outcomes. Mentor and guide junior team members, fostering a culture of excellence, innovation, and continuous learning. Contribute to technical documentation, internal playbooks, and customer-facing collateral. Champion knowledge sharing, best practices, and internal training within the PAS team. Bachelor s or Master s degree in Computer Science, Life Sciences, or a related field. Minimum of 10 years experience in configuration, implementation, and validation of enterprise lab informatics systems such as LIMS, ELN, LES etc. Desired Skills Strong understanding of the Pharma and Life Sciences domain, with working knowledge of regulatory expectations. Thorough understanding of business processes in the pharmaceutical labs such QC and R&D. Working knowledge and exposure to various LIMS, ELNs and other Informatics applications used in Pharma labs. Working knowledge and exposure to various lab instruments and their governing software, e.g., Empower and controlled instruments, Chromeleon, SoftMax Pro, Tecan Magellan, UNICORN and controlled AKTA Chromatographic instruments, LabX and controlled instruments like pH meters, balances etc. Should be well versed with 21 CFR Part 11, ALCOA+, and GAMP5, GxP regulations. Proven ability to communicate persuasively and influence stakeholders through consultative engagement and value-based storytelling. Experience working in or leading Agile teams. Ability to understand and translate customer needs into technical requirements and collaborate closely with Software Application Specialists. Skilled in balancing technical depth with business alignment; able to contribute to both strategic planning and hands-on delivery. Customer-Centric Mindset: Consultative approach with focus on identifying pain points and delivering tailored solutions. Strategic Alignment: Operates with a strong understanding of Scitara s vision and product roadmap. Domain-Aware Execution: Considers the broader needs of the pharma and life sciences sector in solution delivery. Storytelling & Communication: Communicates complex concepts with clarity and conviction, especially during demos and executive discussions. Exposure to scripting languages (JavaScript, Python), data platforms (databases or data lakes), and cloud infrastructure (especially AWS). Exposure to data standardization models like ASM, AnIML, SiLA. Experience working with monitoring tools, deployment frameworks, or infrastructure automation is an added plus. Capability to align team-level execution with company-wide objectives, while driving performance and operational efficiency. Join a fast-growing, globally recognized platform revolutionizing lab connectivity within the pharmaceutical and life sciences industries. Collaborate with industry-leading experts and innovative thinkers, gaining exposure to some of the brightest minds driving scientific progress worldwide. Contribute directly to impactful scientific innovation, enabling breakthroughs that accelerate research and development on a global scale. Work at the forefront of cutting-edge technologies, including AI-driven laboratory automation and advanced integration solutions. Be part of a transformative movement toward smart labs , leveraging artificial intelligence and automation to redefine how laboratories operate. Engage in projects that shape the future of pharma and life sciences, enhancing efficiency, accuracy, and data-driven decision-making in critical research environments. Experience a dynamic, forward-thinking culture that fosters continuous learning, creativity, and professional growth.

Draft/review contracts, ensure pharma regulatory compliance, handle IP matters, represent company in legal proceedings, develop risk management strategies, and support audits/investigations. Strong negotiation, communication, and analytical skills. Required Candidate profile LLB degree, 5+ yrs corporate law exp (2+ yrs pharma/healthcare). Expertise in pharma regulations, contracts, IP, and litigation. Apply on : 8591061941 sunidhi.yadav@cygnusad.co.in

Draft/review contracts, ensure pharma regulatory compliance, handle IP matters, represent company in legal proceedings, develop risk management strategies, and support audits/investigations. Strong negotiation, communication, and analytical skills. Required Candidate profile LLB degree, 5+ yrs corporate law exp (2+ yrs pharma/healthcare). Expertise in pharma regulations, contracts, IP, and litigation. Apply on : 8591061941 sunidhi.yadav@cygnusad.co.in

Position will be responsible for QA function. Develop, implement and maintain the Quality Management System (QMS) at Scitara. Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements and establish the training function within Scitara. Key Responsibilities Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements. Responsible for authoring, reviewing and approving Standard Operating Procedures, Work Instructions, Policies, Manuals and Guidance documents for Scitara. Represent Scitara in customer audits, regulatory inspections and certification audits (ISO 27001 and SOC II Type 2). Responsible to ensure education and awareness about audit / inspection readiness in the organization. Impart training on SOPs and regulations. Manage CAPAs and deviations at an organizational level. Ensure that software systems meet regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5). Provide QA oversight for all phases of validation (planning, testing, deployment, and change control). Review and approve validation deliverables (e.g., Validation Plan, Test Plan, Test Scripts, Traceability Matrix, Validation Summary Report). Implementing the data privacy policies and associated processes in Scitara across functional units. Bachelor s or Master s degree in appropriate field of study. IT CSV QA candidate with 08-10 years experience in QA, IT and Computer System validation with some background of Software Development. Expertise in validation principles and validation types, software development best practices, and quality management systems used in the FDA/MHRA/EMA regulated environments is required. Preferably, candidates who have worked / supported Pharma / Life Sciences companies. Desired Skills Knowledge and understanding of GxPs and other governing regulations, both local and international. Understanding of quality systems processes and their implementation.

Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. About the position: Market Development Manager, Urology Your Responsibilities will include: Meet or exceed the assigned therapy development objective for each therapy category while maintaining expenses within assigned expense limits. Achieve Personal & Support the Uro lines of business and help organization achieve the desired sales objectives. Work cooperatively with respective Sales personnel for comprehensive and optimum coverage (pre-decided accounts for each quarter per therapy)and product portfolio bundling opportunities Establish and maintain positive and cooperative working relationships with customers, conducting his or herself in a professional and responsible manner at all times. Conduct / hand-hold sales team for successful technology-based Physician/ Technician Training Programmes , Product demonstrations , In-Service programs to ensure optimum utilisation of the Therapy. Conduct analysis of competitor activities, customer needs, technology and infrastructure, therapy adoption etc. relevant to own products in-country in order to analyze impact of market conditions, guide local franchise operations teams, report back to the regional team & highlight possible modifications to the regional/ franchise marketing plans. Work along with Sales Team & Service Engineer/s to sign AMC/CMC with all installations and help generate revenue stream especially for relevant technologies in Urology. Work with Centre of Excellence for each Therapy Area to optimize on targeted therapy development and advance lead funnel. Drive applications & penetrations of assigned equipment primarily in all BSC installations in a planned way as per targets. This will include training account manager/s, technicians, physicians on Patient Selection , Procedure Preparedness, Successful Procedure, Tracking Outcomes & Collecting Involve in clinical discussion with the suggested Urologists as suggested by Sales Team regarding the technical specifications of the capital equipment. Establish relationships with KOLs in the field; Identify key Physician champions for franchise; Develop support structure and relationship with sales representatives and sales management. Assist the marketing team in formulating strategies, tactics and action plans to engage / advance segment-wise customer. Co-develop and partner in implementation of marketing programs according to plan and budget with Sales & Marketing Teams. Work with Marketing Team in establishing, monitoring and drive clinical message related the therapy. Work with the team to identify opportunity in potential accounts as defined in strategic map for capital equipment and work with all stake holders to close the deals. Work closely with the tender management team to ensure that we can lock in tenders with our specifications and win. What were looking for in you: Bachelor s degree in business or sciences and at least 5 years of medical device/ pharmaceutical therapy development. Track record of quota attainment selling high-value products to multi-level decision-makers. Existing relationships within the healthcare hospital industry/ KOLs. Strategy development, project management, problem solving, and change management skills. Solid understanding of healthcare and regulatory requirements and issues. Understanding of OT Environment and working within the regulatory requirements, ensure safety of patients / HCPs / self and other stake holders. Exceptional Communication Skills to effectively communicate therapy related information. Ability to build positive working relationships, both internally and externally. Ability to effectively present information and negotiate with all levels of management including CFO, CIO, CEO, CMO as and when required. Clinical aptitude in Urology. Requisition ID: 607052 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

About VSM Software VSM Software (P) Ltd isan ISO certified company catering to the global needs of Pharma and Bankingindustries. In both these verticals,we offer solutions and services in specific areas. VSM has Strong founding team based in India and the US A great leadership team who come with high levels of educational qualifications and relevant industry experience Skilled and trained IT and Subject Matter professionals We have a local presencein 5 countries and are further expanding our delivery reach. About the team The .NET Development team comprisesskilled developers specializing in building robust, scalable, and secureapplications using the .NET framework. They focus on creating web and desktopsolutions, integrating APIs, and maintaining existing software to meet businessrequirements. The team stays updated with the latest .NET technologies toensure efficient coding practices, timely project delivery, and seamlesssoftware performance. Responsibilities Develop and maintain responsive web applications using JavaScript, CSS5, JQuery, and HTML. Optimize code for performance, scalability, and cross-browser compatibility. Debug and test front-end features to ensure functionality and responsiveness. Design and implement backend logic and APIs using ASP.NET Core.

Job Summary: The successful candidate will be responsible for developing and implementing regulatory strategies for new products, managing the life cycle of existing products, conducting SEC meetings, and drafting critical responses to new product queries and legal matters. Key Responsibilities: Develop and implement overall regulatory strategy for new products. Manage the life cycle of existing products, ensuring compliance with regulatory requirements. Conduct SEC meetings and ensure all regulatory submissions are accurate and timely. Draft critical responses to new product queries and legal matters. Collaborate with cross-functional teams to ensure regulatory compliance and support product development. Monitor changes in regulatory requirements related New products and communicate their impact on the company s products and processes. Provide regulatory guidance and support to internal teams and stakeholders. Qualifications: Bachelors / Masters degree in Regulatory Affairs, Life Sciences, or related field. Advanced degree preferred. Minimum 10-12 years of experience in regulatory affairs Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to manage multiple projects and deadlines. Detail-oriented with strong analytical and problem-solving skills.

The incumbent will be responsible driving the secondary sales and merchandizing by building and developing long term relationships with the retailers Key Stakeholders: Internal Marketing, Supply Chain, Human Resources, Sales Development Key Stakeholders: External Retailers, Wholesalers, Distributors, Key Accounts customers Reporting Structure: Will report to Sales Officer Experience: 2-3 year of sales experience in FMCG/Pharma/OTC industry preferred in channel management Product understanding Negotiation Good local geographical Knowledge Local Language fluency Distributor Management Basic Calculation of retail scheme/ distributor scheme Graduate / MBA Cover Superstore outlet in the respective territory Achieve assigned monthly Target Responsible for New Outlet Opening Responsible for New Product Launch Manage the performance of superstore channel to improve our sales revenue. Ensure POB conversion into secondary sales with DMS execution Mobile reporting (Attendance Sales) on daily basis Responsible for repeat frequent order from outlets Responsible for merchandising store branding Develop Maintain strong relationship with channel Partners.

As a Principal Data Engineer at Alexion, you will be at the forefront of developing cutting-edge data integration solutions that cater to the dynamic needs of our global data platforms. Your expertise will be pivotal in designing, implementing, and managing robust data pipelines and integration paradigms. Collaborate closely with diverse IT teams to support data-driven decision-making and strategic initiatives. Your mission will be to build scalable, reliable, and resilient data solutions, enhance data quality and observability, and ensure compliance with industry standards and regulations. Become an advocate for data governance and best practices, empowering Alexion to leverage its data assets for business innovation and success. Accountabilities: Develop and maintain high-quality data integration solutions to support business needs and strategic initiatives. Collaborate with IT teams to identify data needs, structure problems, and deliver integrated information solutions. Ensure the quality and security of Alexion s data through the implementation of best practices in data governance and compliance. Stay abreast of industry trends and emerging technologies to drive continuous improvement in data engineering practices. Essential Skills/Experience: masters Degree in Computer Science, Information Systems, Engineering, or a related field. A minimum of 10 years of experience in data engineering, data management, and analytics. Proven track record of delivering large-scale, scalable, secure, and robust data solutions in the pharmaceutical or life sciences industry. Strong experience with SQL, Python, ETL/ELT frameworks, and building data orchestration pipelines. Expertise in cloud architectures, particularly AWS. Proficiency in Snowflake and its features (resource monitors, RBAC controls, etc), dbT, Fivetran, Apache Airflow. Strong analytical, problem-solving, and organizational skills. Ability to effectively communicate complex data insights and solutions to diverse audiences, including senior leaders. Advanced understanding of data warehousing methodologies and data modeling techniques (Kimball, 3NF, Star Schema, ). Understanding of data governance, compliance standards (GDPR, HIPAA), and FAIR and TRUSTED data principles. Desirable Skills/Experience: Extensive experience (5+ years) within the biotech/pharma industry. Familiarity with Kubernetes, Docker/containerization, and Terraform. Knowledge of data quality and observability tools and methodologies to enhance data reliability.

As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). you'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: bachelors Degree (Minimum) or masters Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format.