178 Medical Affairs Jobs - Page 4

Job title : Central CRA (Clinical Research Associate)- Registries Hiring Manager: Project Lead - ESR and Grants Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About the job Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and RD, Data Digital functions . Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool. Main responsibilities: The Central CRA serves as the primary liaison for the Principal Investigator and other site staff involved in conducting rare disease registries at the investigational site. Feasibility Activities: Involvement in the site selection process together with the Registries Team. Study Start-up Activities: Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB) Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA. Prepare EC cover letter and any additional materials required (if applicable) Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable) Prepare the Insurance Certificate application when applicable. Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites. Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable) Assist with the upload file of Study Start-up documentation into the eTMF. Ensure that all parties are informed about project progress, changes, and any issues that arise. Site Monitoring: Off-Site Visits Perform remote site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. Plan, prepare, conduct, report and follow up site (and satellite sites) remote visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. Onsite (where local hub affiliates are located) Perform onsite site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. Plan, prepare, conduct, report and follow up Onsite site (and satellite sites) visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. Management of the Site Data: Reviews study data from various sources remotely. Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects. Site Management: Recruitment Follow up on patient enrolment and patient status. Site facility staff: Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local). Assure site staff training and access to different systems. Develops collaborative relationships with investigational sites and other stakeholders as applicable. Liaise with Vendor for different activities (startup, onsite monitoring). Safety Quality: Assure adequate safety reporting process of the site, and that site is submitting and/or notifying safety information to EC/IRB/RA according to country regulations, site SOP. Quality control of study conduction at site level - with "Audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary. Study administration: To maintain all the tables, trackers and databases updated to follow the study progress locally and globally. To know and use all the tools needed. Participates in the investigator payment process, if applicable To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required. Study Meetings: To participate with the rest of the study team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings. People: (1) Seek alignment with internal stakeholders, External stakeholders, or Principal Investigator to ensure integration and appropriate prioritization of Registry study activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business Performance: (1) Maintain study Start-Up Timelines and Monitoring Visit Frequency and Quality which includes adherence to the monitoring plan, thoroughness of data verification, and timely resolution of issues (2) Data Quality and Integrity: accuracy and completeness of data collected at the sites. This can be assessed through the number of data queries raised and resolved, and the frequency of data discrepancies (3) Regulatory Compliance: maintaining compliance with regulatory requirements. Adherence to Good Clinical Practice (GCP) guidelines, and proper documentation. (4) Patient Recruitment and Retention: effectiveness in supporting patient recruitment and retention efforts. (5) Communication and Collaboration: ability to communicate effectively with site staff, sponsors, vendors, and regulatory bodies. This includes responsiveness, clarity of communication, and the ability to resolve conflicts. (6) Training and Development: commitment to ongoing professional development and training. This can be measured by participation in training programs and staying updated with industry best practices. (7) Efficiency in Reporting: maintaining the timeliness and accuracy of the CRA s reports, including monitoring visit reports, progress reports, Process: (1) Involvement in the site selection process together with the Clinical Project Lead (CPL), Registries Regional Leads and Local Medical Affairs. (2) Assist in the collection of site documents, Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee. Prepare EC cover letter and any additional materials if required. Ensure appropriate follow-up with EC for additional questions and to inform sites (if applicable). Prepare the Insurance Certificate application when applicable. Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites. Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site, if applicable Assist with the upload file of Study Start-up documentation into the eTMF. (3) Plan, prepare, conduct, report and follow up site (and satellite sites) visits-Site Selection, Site. Initiation, Routine Monitoring (Remote /) and Close Out Visits according to Study. Manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. (4) Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects. (5) Assure adequate safety reporting process of the site, and that site is submitting and/or notifying safety information to EC/IRB/RA according to country regulations, site SOP. Quality control of study conduction at site level - with "Audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary. (6) To maintain all the tables, trackers and databases updated to follow the study progress locally and globally. To know and use all the tools needed. To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required. To participate with the rest of the registries team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings. Stakeholder: (1) CRAs identify all relevant stakeholders, including sponsors, investigators, regulatory bodies, and patients. Understanding each stakeholder s role and influence is essential. (2) Communication: Effective communication is vital. CRAs ensure that stakeholders are kept informed about the study s progress, any issues that arise, and the outcomes. This involves regular updates, meetings, and reports. (3) Building Relationships: Establishing and maintaining positive relationships with stakeholders is crucial. This involves understanding their needs, expectations, and concerns, and addressing them promptly. (4) Conflict Resolution: CRAs often mediate conflicts between stakeholders. They must be adept at negotiating and finding solutions that satisfy all parties involved. (5) Compliance and Ethics: Ensuring that all stakeholders adhere to regulatory and ethical guidelines is a key responsibility. CRAs monitor compliance and address any deviations promptly. (6) Feedback and Improvement: Gathering feedback from stakeholders and using it to improve processes and outcomes is an ongoing task. This helps in building trust and improving future collaborations. About you Experience : 3+ years of experience in Clinical research development including clinical trial monitoring experiences. Rare diseases or observational studies, real world evidence experience will be a plus. Attention to Detail: Critical for monitoring trial data and ensuring accuracy.

Skill required: Pharmacovigilance Services - Medical Affairs Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 4 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for Ability to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification MBBS

Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Job Overview Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and specifications. Participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations Key Stakeholders: Internal Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership team Key Stakeholders: External Country Distributors, Health Authority (HA), CMOs and external partners Reporting Structure Reports to: Manager - Labelling ESSENTIAL QUALIFICATION: Bachelor degree or Master s degree in Pharmaceutical sciences or equivalent Experience 4 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred) Roles and Responsibilities: Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions Preparation of Labelling related documents ex: SmPC, PIL and Labelling texts for submission in EU region. Coordinating with the different stakeholders for timely labeling related submission/approval and query solving. Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copy to ensure accuracy of labeling Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA Monitor and process innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs Responsible for coordination of CCDS development and updates of PCC products and coordination of local labeling updates Contribute to the development and/or review of all labeling aspects included in Promotional Material. Development and maintenance of a central repository for all labeling components Competencies Must have solid interpersonal and organization skills for interfacing with others. Knowledge of Health Authority labeling regulations and requirements. Self-directed, motivated, organized, flexible and accountable. Excellent work ethic with a positive, can-do attitude to succeed in a fast-paced environment. Project management skills is a plus

Skill required: Marketing Operations - Medical Affairs Designation: Copywriting Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designDesign, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for Medical ReviewMedical MonitoringContent CreationProblem-solving skillsAgility for quick learningResults orientationCommitment to qualityWritten and verbal communicationClinical Data Review Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Hi We are Hiring for the job role of Medical Writer Job Description: * Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. * Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. * Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. * To work in coordination with all the members in the study team- internal and external for the development of clinical documents. * Share project timelines amongst the study team for the development of document. * Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. * Review statistical analysis plans and table/figure/listing, when required. * Ensure uniformity and consistency in the scientific content of the regulatory documents * Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. * Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. * Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. * Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. * Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. * Plan and organize project and non-project meetings, as and when required To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57

Job Description The Position External Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) is a vital, global activity that spans across many Organon functions. The lack of a centralized group or process to manage the HCP engagements has each function and region developing their own processes and/or using disparate vendors. There are immediate opportunities for harmonization, optimization & advancement of this capability for HCP Strategy & Identification, Planning & Execution as well as within HCP Operations (FMV, Contracting, Payments and Technology Enablement). The HCP Enablement Resources (HER) Project can enable Organon to benefit from harmonized strategy & execution more efficient operations, addressing compliance and reputational risks and create a scalable platform for future growth. The Senior Specialist oversees and manages all HCP Fee-For-Service agreement requests originating from in R&D, Commercial and/or Global External Affairs both in the United States and Ex-US, as required. This role interfaces with internal stakeholders to plan and coordinate annual HCP engagement needs, restricted expert lists, and strategic utilization of experts and the operationalization/execution of due diligence, contracting, meeting planning & events and payments. Responsibilities: Serve as a point of contact for external consultants (KOLs, Thought Leaders, HCPs, etc.) and internal matrix teams. Act as a resource on processes and systems, including planning, execution, and issue management/resolution. Support the HER Project medical, commercial, R&D, and external affairs teams on processes, resources, and capabilities. Support vendor relationships, including due diligence, contracting, and logistics. Guide stakeholders, providing recommendations and support for consultant engagements (e.g., speaker, advisory boards, presentations, symposia). Develop and contribute innovative solutions for process simplification and harmonization. Manage strategic engagement processes, including cross-border engagements, scientific leader relationships, and medical association partnerships. Required Education, Experience and Skills: A bachelor s degree in science, business, healthcare, or a related field is required, with a strong preference for a concentration in a scientific or applied discipline. An advanced degree (e.g., MS) is preferred. Project management certification (PMP) and/or formal coursework/training in project management is strongly preferred. 2-5 years of biopharmaceutical experience. 2+ years in Research and Development (R&D) and/or Commercial Operations roles Experience in the pharmaceutical industry in commercial and/or medical affairs. Experience collaborating with medical/scientific leaders. Experience working with medical associations and societies. Strong communication and interpersonal skills Project management Collaboration and relationship management Understanding of the drug development process and HCP fee-for-service engagements Attention to detail and critical thinking Ability to embrace change and innovation Cultural sensitivity and cross-geographical collaboration Secondary Job Description Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. Search Firm Representatives Please Read Carefully Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1

Hi, We are hiring for the Leading ITES Company for Medical Writing Role. Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required Key Skills: a) Min 1 Year Experience in Clinical Study and Summary Writing Common Technical Document. b) Should have Experience in making Clinical Study Pharmacology Report, Clinical Study Report and Clinical Summary of Safety c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396

Hi We are Hiring for the job role of Medical Writer Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 47 b) To Apply for above Job Role ( Pune ) Type : Job Code # 48 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 51

Summary At Novartis, we are reimagining medicine to improve and extend people s lives. Within the Commercial domain of our Data, Digital & Technology (DD&IT) organization, we re leveraging data, AI, and digital tools to reshape how we engage healthcare professionals (HCPs), optimize field force strategies, and deliver personalized experiences at scale. As Associate Director - UI/UX Engineering, you ll lead the design and development of AI-powered tools and user experiences that drive data-informed decisions and unlock real commercial value. From omnichannel engagement platforms to next-best-action systems for the field force, you ll ensure every solution we build is human-centered, intuitive, and impactful. About the Role Position Title: Senior UI/UX Engineers - Data Science Products ( Sr. Engineer DDIT US&I UI) Location - Hyd-India #LI Hybrid Role Purpose UI/UX Engineering, you ll lead the design and development of AI-powered tools and user experiences that drive data-informed decisions and unlock real commercial value. From omnichannel engagement platforms to next-best-action systems for the field force, you ll ensure every solution we build is human-centered, intuitive, and impactful. Your responsibilities include but are not limited to: Define and lead UX strategy for commercial AI products focusing on usability, trust, and adoption across a variety of personas (e. g. , sales reps, marketers, commercial analysts, and medical affairs teams). Design intelligent user interfaces that translate complex AI/ML outputs (e. g. , next-best actions, predictive targeting, engagement recommendations) into actionable and explainable workflows. Collaborate with commercial product leads, data scientists, CRM architects, and omnichannel strategists to align business goals with user needs and technical feasibility. Lead the end-to-end design process: user research, journey mapping, wireframes, prototyping, high-fidelity UI, usability testing, and design iteration. Ensure seamless collaboration with front-end developers to bring designs to life emphasizing performance, accessibility, and consistency. Guide the evolution of a commercial design system that aligns with Novartis brand and scales across multiple tools and platforms. Act as a UX evangelist across Commercial Tech, presenting to senior stakeholders and influencing design thinking across regions and business units. What you ll bring to the role: Experience working with AI/ML teams and translating model outputs into usable, transparent, and explainable UIs. Strong technical fluency in frontend technologies (React, TypeScript, APIs) and familiarity with enterprise-scale design system implementation. Exceptional communication and stakeholder engagement skills, with the ability to present design rationale to cross-functional teams and senior leadership. Proficiency in Figma, Adobe XD, Framer, or similar tools , and experience with accessibility and compliance in pharma or regulated environments. Experience designing solutions for commercial functions in pharma, life sciences, or healthcare (e. g. , field force enablement, HCP engagement platforms, market insights dashboards). Desirable Requirements: Bachelor s or master s degree in computer science, Engineering, Business, or related field. 7+ years of experience in UI/UX design or UX engineering, with at least 2 years in a leadership or high-impact role within large-scale commercial environments. A proven track record of designing AI-integrated interfaces for sales, marketing, CRM, or omnichannel platforms. Strong understanding of human-centered design , information architecture, and user psychology especially in data-rich or decision-support environments. 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:

Job Purpose and Key Responsibilities: Provide support for Central Safety Department (CSD) literature screening activities for both ICSR and signal detection purposes in accordance with their procedures and regulatory requirements Support SERM product specialists by identifying articles of interest for relevant safety information from screened publications for all of GSK s product portfolio Perform PV literature surveillance activities according to appropriate regulations and agreed processes Ensure timely production of key deliverables including but not limited to: Screening and review of literature search results (articles/abstracts/citations) for purposes of ICSR identification Triaging literature search results for potential articles of interest with relevant safety information concerning both GSK marketed and GSK products in development, for signal detection/periodic reporting purposes using defined algorithms and criteria Accountability: Breadth/Scope of Accountability - Number of Direct Reports Number of Indirect Reports 0 0 Complexity (this is best illustrated for this role by the behaviors needed to perform effectively): Decision Making: Developing confidence in making decisions Makes decisions based on facts, common sense with the support of mentors or manager Understands and can articulate decision making process Teamwork: Works effectively with others to achieve business goals and objectives Bridges personal, business and cultural differences to work effectively in team settings Communication: Has effective communications with internal audiences, tailoring information appropriately Responds with confidence to more complex questions using sound judgment Translates complex science into simple messages that resonate Competencies: Minimum level of job-related experience required: 0 to 2 years of relevant industry experience Pharmaceutical industry experience (e g drug safety (desired), regulatory, clinical development, medical affairs) Working knowledge of key pharmacovigilance regulations and methodologies Good English language skills - written and verbal particularly in scientific/medical terminology Ability to evaluate data and draw conclusions with appropriate guidance from senior team members or manager Good attention to detail Good interpersonal, presentation and communication skills Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment Computer proficiency, IT skills, the expertise and ability to work with web-based applications Good level of flexibility and ability to prioritize work Education: Minimum level of education: Bachelor s Degree - Life sciences (Biology, chemistry, pharmacy, medicine or other relevant scientific discipline) Preferred level of education: Pharmacy, Medical or pharmacology degrees

Title: Senior Program Manager Date: 27 May 2025 Location: Bangalore, KA, IN Job Description We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below. Role: Sr Program Manager Description: We are looking for a highly talented Program Manager. The Program Manager will lead and drive the delivery of client-defined strategies, ensuring seamless coordination across cross-functional teams in Medical Affairs, Clinical, and Commercial areas. This individual will own and manage an independent program, responsible for the end-to-end execution of the strategic initiatives for the assigned compounds. They will play a pivotal role in ensuring alignment with client leadership, overseeing the programs progress, managing multiple projects, and delivering results on time and within scope. This role requires someone who is highly skilled in project management, with a deep understanding of Medical Affairs, and possesses strong leadership abilities to drive teams effectively. Responsibilities: Lead and independently manage and drive the execution of the program across various compounds. Develop detailed project plans, breaking down tasks, setting clear milestones, and ensuring timely completion of deliverables. Monitor and track program progress, providing regular updates to leadership and stakeholders. Anticipate and resolve risks, proactively managing challenges to maintain the program s timeline and objectives. Understand the client s strategy and ensure its implementation through effective project management. Translate strategic objectives into actionable tasks for cross-functional teams, ensuring all activities are aligned with the broader business goals. Regularly report progress to leadership and stakeholders, highlighting key milestones, challenges, and results. Prepare comprehensive status reports, detailing project timelines, risk mitigation efforts, and next steps. Ensure clear communication of updates, risks, and changes across all levels, providing timely responses to questions and concerns. Identify opportunities for improvement within the program and processes, implementing best practices and innovative solutions. Must Have Minimum of 8-10 years of experience in program management, ideally within the pharmaceutical, medical, or clinical fields. Education Qualification - M Pharm or Pharm D A deep understanding of Medical Affairs is essential, with experience in Clinical and Commercial areas being an added advantage. Experience managing multiple projects simultaneously and across cross-functional teams. Prior experience working with multidisciplinary teams is mandatory. Must be able to communicate effectively in English, both written and verbally, with all levels of the organization. In-depth knowledge of project management methodologies with strong skills in creating and managing Gantt charts, tracking progress, and meeting deadlines. Ability to understand client strategy and translate it into clear, actionable project plans and initiatives. Ability to anticipate risks, proactively solve issues, and ensure projects remain on track. Strong leadership abilities to manage and inspire cross-functional teams. Excellent at managing relationships with both internal and external stakeholders. Must be highly organized, ensuring all tasks are broken down and tracked meticulously. Comfortable in a fast-paced, ever-changing environment, capable of managing multiple priorities. EQUAL OPPORTUNITY

Skill required: Pharmacovigilance Services - Medical Affairs Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 2 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for Agility for quick learningAbility to work well in a teamAdaptable and flexible Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification MBBS

Educational Qualification- Post-graduate degree in Pharmacology or other Medical speciality/ Graduate degree in Medicine Minimum work experience - 6-12 years of relevant experience as Medical Advisor with a minimum of 3 years of experience in GASTRO Therapy Area. Must have a prior experience of NCE/NBE launches in GASTRO Therapy area Skills & attributes Technical Skills • Basic knowledge of pharmaceutical industry, drug discovery, research & development, commercialization, promotion, and applicable policies, procedures, regulations, and guidelines • Knowledge of “pharmaceutical medicine” including clinical pharmacology, medical and paramedical sciences, medicine and medical statistics and relevant Therapeutic Area/Products • Expertise in clinical trial design and methodology, and understanding of interfaces, and conduct Behavioural Skills • Communication skills, both written and verbal (including medical writing and presentation skills) • Analytical skills and reasoning, and sound medical judgment/decision making • Interpersonal skills, internal & external networking and the ability to impact and influence. Job Summary We are looking for experienced and dynamic T eam Lead in Medical Affair team for Gastro TA to actively contribute to the organization/business by taking people managerial responsibility and being responsible for the scientific, technical and ethical soundness of all policies, statements and endeavours. He/she will need to provide high quality and timely service in the areas of product commercialization/promotional support, interactions with healthcare professionals, continuing medical education, clinical research, sales force training, medical information, and performance/people management, and business support in the areas of new product development, regulatory affairs, quality standards, and information technology; alliance management may be included as applicable. Roles & Responsibilities • You will be responsible to provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed • You will be responsible for providing strategic inputs for marketing and brand plans, overseeing the design and execution of medical-marketing programs, and facilitating interactions with healthcare professionals. Additionally, you will initiate, review, and approve promotional and educational materials while ensuring compliance with relevant SOPs, regulations, and industry codes. • You will be responsible for developing, reviewing, and approving protocol documents and supporting materials for various clinical projects. Additionally, you will collaborate with Global Medical Affairs and Clinical Development, organize training sessions for project teams, and provide medical support for safety reporting and ongoing local studies. Furthermore, you will contribute to the planning and execution of Investigational New Drug Applications (NDAs). • You will be responsible to provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external customers. • You will be responsible for training the Sales Force on basic sciences/assigned products and pre-launch and launch training for new products. • You will assist the New Product Planning team in preparing business cases and pre-commercialization programs for global products, development of local formulations and line extensions. Additionally, you will provide support in market research, stakeholder mapping, and early access programs. You will also collaborate with various departments to evaluate commercial opportunities, including licensing, acquisitions, and co-promotion. • You will be responsible for providing medical and product expertise in the registration of new products/indications, as well as defending marketed products to various stakeholders. You will also oversee the writing and review of labelling documents and provide medical support for the processing of adverse event reports, adhering to relevant SOPs and practices. • You will be responsible to develop and share expertise in identified medical and/or scientific therapeutic area, including but not limited to disease areas, markets, products (DRL products and key competitors) and services. • You will be responsible to develop and share expertise in a specific medical/scientific subject, including protocol design, development, and training, Pharma co economics, Outcomes Research, Health Technology Assessment, New Product Evaluation, Disease Management Programs, Intellectual Property Protection and Patents, and Medical Information • You will be one-point Medical Affairs contact for Customer Relationship Management and operational liaison in the various functional domain. • You will be responsible for fostering a culture of learning and development and managing the Medical Affairs staff, providing training, guidance, and support across various functional domains, ensuring adherence to company values and behaviours, and. • You will be responsible to support cluster Head Medical Affairs in budgeting, provisioning and expense control. Interested candidates can apply who is handling a team and working in gastro segment

Sam Tech Datasys Pvt. Ltd. is looking for Medical Transcription Trainer to join our dynamic team and embark on a rewarding career journey. Identifying training needs: Assessment of employee skills and knowledge gaps to determine the type of training required Designing training programs: Creating customized training programs that meet the specific needs of the organization and its employees Delivering training sessions: Leading classroom-based or online training sessions, using a variety of teaching methods to engage participants and enhance learning Evaluating training effectiveness: Monitoring and evaluating the impact of training programs on employee performance and business outcomes Keeping up to date with industry developments: Staying informed of new trends and developments in the training field to ensure the organization's training programs remain relevant and effective

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world s most serious diseases. But we re more than one of the world s leading pharmaceutical companies. Job Description To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. LSADs s might have different internal titles based on the experience level (LSAD, Senior LSAD). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head Senior Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head. Typical Accountabilities Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations. Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations. Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head Ensures timely preparation of local Master CSA (including site budget) and amendments as needed. Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations. Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs. Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction). Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations. Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans. Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters. Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs. Proactively identifies risks and facilitates resolution of complex study problems and issues. Organises regular Local Study Team meetings on an agenda driven basis. Actively works towards achieving good personal relationships with all Local Study Team members, sites staff and global stakeholders. Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead. Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary. Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed. Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable. Plans and leads National Investigator meetings, in line with local codes, as required. Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies. Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level. Ensures accurate payments related to the study are performed according to local regulations and agreements. Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and AZ Procedural Documents. Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF Inspection Ready . Ensures that all study documents are ready for final archiving and completion of local part of the eTMF. Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA. Provides input to process development and improvement. Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues. Updates Line Managers about the performance of the CRAs/CSAs. Ensures that study activities at country level comply with local policies and code of ethics. Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. Ensures compliance with AstraZeneca s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). Collaborates with local Medical Affairs team. Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management. Why AstraZeneca? At AstraZeneca we re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We re on an exciting journey to pioneer the future of healthcare.

Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Senior Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) ;The Senior Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Senior Statistical Programmer will ensure SOPs are followed and timelines and quality are met. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product - with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About you Experience : Masters degree minimum 4 years/B.Sc. minimum 6 years of relevant experience required Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) Education : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages : Excellent English language knowledge - written and spoken

We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. The Scientific and Medical content teams at Indegene work on different projects across the product life-cycle from regulatory, safety, medical affairs and commercial solutions for our clients. The team leverages the clinical and scientific knowledge and applies to various business problems to reach to various target audiences like the physicians, patients across different therapy areas. In light of this, the role holder in Content Solutions would get an opportunity to learn and partner with healthcare clients on various projects. Summary: Indegene is looking for a scientific writer and reviewer to serve as a quality medical reviewer/technical reviewer for promotional, disease education and training materials for a pharmaceutical client. Responsibilities: Perform a procedural review to ensure all MCA guidelines are followe'd to include data accuracy review, content supported by the references cited, and data and information are correctly interpreted from the reference. Deliver and be able to review content that is rated high on depth, comprehensiveness, quality and timelines - within a short span of time. Cross-check scientific information against cited references and ensure accuracy (fact checking) Ensure consistency with approved product labelling and check for any off-label communication. Possess a high-level understanding of MCA guidelines for review of materials. Validate reference quality and standards and if the referencing is contextually accurate Cross check consistency in reference citation style Verify presence of essential information like brand and generic names, AE reporting, presence of API etc Interact and defend content based on scientific evidence and facts. Demonstrate passion to learn and write for different therapy areas and markets with strong written and verbal communication / presentation skills Liaise with client medical and other stakeholders and provide clarification on content or references. Ensure quality of review and submission of the jobs within the agreed upon time frame. Prioritize assets for review as per request from Medical Affairs/Medical Review Leads Keep themselves updated on different products TAs Requirements: Advanced bioscience or pharmacy/medical qualification. Excellent communication ability, both verbal and written. Strong scientific acumen and ability to grasp complex therapeutic areas. Total experience - 0-2 years of pharmaceutical industry experience which includes medical affairs/medical information related content writing, review, literature reviews, publications support, promotional/non-promotional medical review.

At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have 1. In-depth knowledge of document review process in platforms like Veeva vault promomats and/or Med comms and other platforms. 2. Demonstrated ability to communicate and troubleshoot challenges by collaborating with cross-functional colleagues, external vendors, and customers 3. Ability to prioritize tasks and manage time effectively to ensure timely delivery of d projects while handling multiple tasks without compromising quality. 4. Familiarity with different deliverable types across Medical affairs and commercial space 5. Undestanding of copyright management for references, images etc and ensuring that L-MACH tactics are PMC compliant 6. Ensuring the tactics are PMC approved before they are routed for medical approval for global use and/or are uploaded on any repository 7. Maintaining the tactics migration tracker from SharePoint to AEM 8. Managing the accuracy of metadata while uploading the PMC assets onto content gallery and tactics onto veevavault for approvals 9. Ensuring the HE fulfilment requests are processed within the defined timeframe Skills 1. MLR Review process 2. Effective communication and colloboration across internal and external stakeholders 3. Time management and stakeholder management 4. Good understanding of MA tactic types 5. Copyright, license agreement management (PMC) 6. Process adherence 7. Expertise in routing platforms such as AEM, SharePoint, VeevaVault, Capacity Planner Tool, Wrike etc

RoleClinical & Therapy Development Manager Type Full Time Job description - Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops) This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

The Patient Solutions Lead is responsible for leading the strategic expansion and digital transformation of patient programs across Southeast Asia and India MCO. This role will elevate the current India-focused program to a broader regional scope, with emphasis on digital transformation and implementation of global tools such as I-care and Saturn. The Patient Solution Lead will coordinate and follow up on global and local-based medical projects and Patient Programs at the Multicounty Organization (MCO) level, expanding from the current diabetes focus to include Rare Disease, Transplant, and Atopic Dermatitis, Asthma, COPD etc., and incorporating PSP diabetes from Philippines. This position will lead the transformation from manual to fully digital programs, establish sustainable partnerships with agencies, and ensure all programs comply with Sanofi policies and local regulations. The Patient Solution Lead will act as a bridge between project centers and the company, lead operational activities, and build relationships with key stakeholders to enhance program effectiveness and patient outcomes. KEY RESULTS - ACCOUNTABILITIES 1. Strategic Leadership Program Development Define and drive the overall PSP strategy in the MCO, in alignment with the unmet need and Sanofi priorities. Lead the digital transformation of existing manual PSP processes to fully digital solutions Drive adoption of global tools such as I-care and Saturn across the region Transform traditional PSP into modern PSP by implementing digital tools establishing common KPIs across the SEA and India MCO Expand the current diabetes-focused PSP to include Rare Disease, Transplant, and Atopic Dermatitis Asthma, COPD and evolving therapeutic areas. Establish sustainable partnerships with agencies to create an integrated MCO Patient program Design and implement patient-centric programs that improve treatment adherence and patient outcomes Define metrics and KPIs to measure program effectiveness and impact 2. Stakeholder Engagement Scientific Partnership Be a trusted scientific partner to key external experts by conducting timely, appropriate scientific exchanges and operational support Execute stakeholder engagement plans to gather data, develop and share medical insights that contribute to enhancement of Sanofis patient support programs Maintain effective and appropriate communication among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) Engage with appropriate stakeholders to understand healthcare policies and guidelines as they relate to clinical practices at local, regional, or national levels Establish robust, long-term relationships with Key Opinion Leaders and other stakeholder partners Organize educational meetings or scientific advisory boards in line with medical plans when requested 3. Program Management Operations Lead the implementation and control of all preparations before the launch of Patient Support Programs Monthly monitoring and follow-up of program metrics and budget of local medical projects Manage, implement, control and conduct Managed Access Programs (MAP) where applicable Ensure that launch meetings are organized in the regions with all relevant parties and trainings are conducted Select suppliers to ensure correct management of PSP with regional scope and identify/manage deviations and risks Monitor the work of providers to meet standards of excellence, especially in cases involving medication administration to patients Manage the PP Tracker tool, including uploading all related changes to the PSP, approving renewals, and tracking new and cancelled programs Follow up on compliance with the indicators agreed with providers and implement action plans when there are deviations Budget and resource planning and management in partnership with Finance (PSP typically manages 25-30% of product AP) 4. Digital Transformation Innovation Lead the transition from manual to digital processes across all patient programs Implement and drive adoption of global digital tools and platforms (Icare, Saturn) Develop innovative digital solutions to enhance patient experience and program efficiency Collaborate with IT and digital teams to ensure seamless integration of systems Drive innovative solutions/models answering specific patient needs, pioneer new operating models and ways of working Foster learning and encourage thoughtful risk taking by sharing best practices and innovative initiatives 5. Insights Generation Knowledge Management Gather data and generate insights from stakeholder interactions and provide feedback to the organization Recognize and collect feedback/reactions from multiple data sources and various stakeholders Ensure accurate forecast plans for patient support initiatives, including budget allocation Record/report insights and information appropriately, using available mechanisms and tools Critically evaluate information from published studies and stakeholder interactions to deepen understanding of market needs 6. People Leadership Build and lead a high-performing team across the region Foster a culture of innovation, compliance, and patient-centricity Manage performance through setting and reviewing priorities, providing appropriate feedback, and coaching team members Support professional and career development by identifying skills and competencies needed for current and future roles Lead the building of a motivated and engaged team through recognition, regular communications, and encouraging cooperation 7. Compliance Ethical Leadership Ensure all programs comply with Sanofi policies, local regulations, and industry standards Take personal accountability to maintain knowledge and understanding of all ethics and governance relevant to the role Demonstrate and promote Play to Win behaviors throughout the organization Escalate any decisions or seek support when personal knowledge is not at the level required Ensure that Sanofi PSP governances, processes/policies as well as available regulations and laws are strictly applied SKILLS, EXPERIENCE KNOWLEDGE REQUIREMENTS Education Experience Bachelors degree required; advanced degree in healthcare, business, or related field preferred (medical doctor, pharmacist, or strong scientific background is an advantage) Minimum 10-12 years industry, Minimum 5 years in a patient program and diagnostics, companion diagnostics . Experience in digital transformation projects and implementation of digital tools Experience working across multiple countries in South East Asia and/or India Experience in leadership in PSP department (program development, program closing, PSP audit experience) Experience in managing senior stakeholders Knowledge Skills Strong understanding of patient support program design and implementation Knowledge of digital healthcare solutions and platforms Experience with global tool implementation and adoption Understanding of pharmaceutical regulations across South East Asia and India Project management expertise with ability to manage multiple complex initiatives Handling of the PSP tracker tool Audit management experience Experience in product crisis management and engagement with patient associations Excellent understanding of Medical Business strategy and operations Proven ability to operate across different business models/product portfolios Competencies Digital-first thinking with ability to drive technological innovation Strong passion for patient-centricity and improving patient outcomes Demonstrated sense of urgency and ability to deliver results in a fast-paced environment Excellent stakeholder management and communication skills Strategic thinking with ability to translate vision into actionable plans Compliance-oriented mindset with strong ethical standards Demonstrated Play to Win behaviors Act for Change Cooperate Transversally Develop People (Self/Others) Leadership Innovative mindset with customer-facing approach Value creator, able to make complex decisions in uncertain environments Transformative leader people developer ROLE CHALLENGES IN 2025-2026 Elevate the Patient Solutions Lead role from India to SEA and India MCO Expand the program from diabetes to Rare Disease, Transplant, and Atopic Dermatitis for Dupixent, including PSP diabetes from Philippines Transform manual programs to fully digital with adoption of global tools (I-care, Saturn) Incorporate different agencies to make the program sustainable Define metrics and KPIs common to all countries of the MCO Implement innovative programs that can be exportable models Reevaluate current programs, understand objectives, and simplify execution Identify efficiencies and opportunities for simplification Ensure seamless roll-out of new Sanofi initiatives (leveraging data and AI) Be a role model of One Sanofi mindset and ways of working Beware of Job Scams: Sanofi Fraud Notice: As you conduct your job search, please beware of the possibility that scammers may post fraudulent job openings or send fraudulent communications (email, SMS, WhatsApp or Messenger messages pretending to be from Sanofi) regarding potential job postings or offers in an attempt to encourage the job seeker to disclose financial or personal information. We do not make any payments to or ask candidates for any fees as part of the application process. In most cases you can expect to hear directly from a member of our recruiting team with a legitimate @sanofi.com email address, but you may receive communications from one of our recruiting partners as well. Consequently, you should always conduct research to ensure a posting and/or offer is legitimate and you should never provide personal or financial information unless you are certain that the request is legitimate. If you are concerned that an offer of employment with Sanofi might be a scam, please verify by searching for the posting on the Careers webpage Better is out there. Better medications, better outcomes, better science. But progress doesnt happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, lets be those people. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity

Regional Medical Advisor (RMA) - General Specialty Medicine, North Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities and Primary Activities Scientific Expertise : Develop and maintain a comprehensive understanding of the companys products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement : Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the companys products and therapeutic areas. Support to Medical Strategy : Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education : Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange : Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication : Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support : Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration : Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives : Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information : Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training : Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance : Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background : A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience : At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise : Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge : Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills : Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills : Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility : Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge : Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Job Posting End Date: 06/30/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Summary In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders About the Role Key Responsibilities Support country medical affairs strategy in line with the global strategy, country insights and market conditions, and implementation of Medical Affairs activities within the designated therapy area(s). Coordinate scientific meeting, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring value to the therapy area; develop engagement plan(s) for country customer-facing activities and events, and ensure timely execution of the activities in an efficient and compliant way. Ensure enquiries are responded to in a quality, timely manner, and in accordance with applicable standards; establish response documents for frequently asked questions. Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the therapeutic area. Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities. Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for partner engagement and events are tailored to local needs, and reviewe'd/approved per local/P3 guidelines. Ensure medical insights are provided to cross-functional groups, including, but not restricted to: Pharmacovigilance, Regulatory Affairs, Market Access, QA, Commercial and Brand team and others. Responsible for risk identification and assessment, mitigation planning as we'll as implementation and monitoring of appropriate internal controls within the area of responsibilities Essential Requirements: MBBS; MD Mandatory with min 1+ year industry experience Operations Management and Execution Project Management Collaborating across boundaries Clinical Trial Design, Data Reporting Medical Science and Disease Area Knowledge Medical Education and Scientific Engagement Non-Interventional Studies (NIS) / Epidemiology Studies Medical Governance and Medical Safety Desirable Requirements: Cardiovascular

Working in partnership with the Client Engagement team, Medical Communications, and the Writing delivery team for a designated client group/therapeutic area (TA)/brand, this role will be responsible for delivering and supporting scientific excellence of Medical Communications services across their accounts. Ensuring medical communications deliverables are aligned with assigned scientific goals and objectives. Ensuring written materials contain appropriate scientific statements and support learning objectives. Developing original content, leading faculty and client communications relating to scientific content of medical communications deliverables. Ensuring quality, scientific accuracy and integrity of assigned projects. Assisting the client to achieve medical communication objectives through creation and execution of scientific and educational materials. Training and mentoring of the Writing delivery teams on selected therapy areas. About the Role Location - Hyderabad #LI Hybrid Major accountabilities: Support for planning and execution of scientific communications for assigned franchises/TA or group of aligned TAs Oversees the delivery of client-requested support of medical/scientific communications plans and medical communications workshops for assigned franchises/TA or group of aligned TAs Leads the review of the medical/scientific communication plans with the stakeholders to ensure that their requirements are met Collaborates with the Content Development - US Medical Affairs in developing plans and materials for, and participating in new business development meetings with existing and prospective clients Demonstrates ability to see the big picture and adds value by identifying the key/broad issues regarding client s product/brand Ensures content Development - US Medical Affairs medical communication deliverables on assigned products/brand(s) are aligned with the product/brand scientific communication strategy and tactics. Therapeutic knowledge Oversees Content Development - US Medical Affairs medical communication content development for high-profile and scientifically complex therapeutic areas Demonstrates the ability to think creatively and applies extensive knowledge of assigned franchises/TA or group of aligned TAs Maintains thorough knowledge of key competitors (strengths, weaknesses, positioning, performance, etc) Proactively and independently maintains knowledge on the product and/or therapeutic category Recommends and implements strategy-aligned and innovative medical communications solutions to meet client needs Demonstrates ability to think about the scientific landscape that shapes a product and provides insights to the client. Editorial and Reviewing Responsible for the quality and scientific accuracy/integrity of projects Ensures written materials and slides meet product objectives and contain appropriate scientific statements and learning objectives Provides guidance and direction to writers/editorial project team Communicates key client issues/initiatives to team accurately and in timely manner Detects/anticipates strategic inconsistencies or potential problems and develops solutions Champions optimum collaboration and ways of working between Content Development - US Medical Affairs the internal client Leads by example in terms of working with the client. Listens to and acts on improvement ideas from both the internal client and Content Development - US Medical Affairs and translates into actionable service improvements Minimum Requirements: Education: Healthcare professional degree or degree in a healthcare-related field Desirable: advanced degree (PhD, PharmD, MD) in life science/healthcare Experience: At least 5 years experience of working with international Medical Communications for either an agency or in an internal role within the pharmaceuticals industry Experience in a wide array of Medical Communications activities, including, but not limited to, publications, slide decks, symposia, standalones, advisory board meetings, etc Track record in developing Medical Communications plans Track record of working effectively in a matrixed organization and / or between complex structures between client and deliver teams Desired experience in digital solutions and innovation Experience in a multi-cultural work environment and international working Strong negotiations stakeholder management skills Leadership skills: Ability to scope and lead content projects, manage internal and external resources and direct content projects through to completion, role models teamwork and collaboration skills Demonstrates excellent executive level verbal, written and presentation skills Anticipates and brings about change as needed; communicates change in a way that supports buy-in and long-term success Utilizes decision criteria such as cost, benefits, risks, timing, and buy-in; selects the strategy most likely to succeed with client(s) Solves Client issues, independently moderate conflicts with significant complexity and political sensitivity and influence senior management decisions Is sought out for advice and counsel; has proven credibility and cross-functional success Sets clear direction and priorities, mentors and coaches staff for improved performance Conveys credibility and maintains positive, professional image both internally and externally Demonstrates ability and willingness to assume a leadership/mentor role within the team Role models professional and positive qualities within the organization Ensures compliance and inspection /audit readiness. Is accountable that all associates in the team are adequately trained and comply with industry best practice (incl. GPP3) and internal guidelines/SOPs