543 Medical Writing Jobs - Page 4

Department New Generation Insulin (NGI) The Position As a Regional Medical Advisor, you will contribute actively to medico-marketing activities in the business area/portfolio and support in implementation of the Medical Affairs strategy in the country. You will be responsible for: Executing the Indian medical strategy into local activities in your designated region Building, maintaining, and nurturing the excellent scientific relationship with all the key influencers and stakeholders Training and educational activities for Physicians and other Health Care Professionals (HCPs) working with diabetes and obesity Medical support to brand team You will also be responsible for: To assist the marketing and sales team in sharpening and positioning product and promotional strategies. Foresee the challenges as well as changing market dynamics and make timely corrective and preventive actions. You will stay updated on scientific knowledge by actively participating in scientific meetings, gathering clinical insights/needs/feedback from key opinion leaders, and communicating with internal stakeholders. Responsible for educating and training the field and marketing personnel and other relevant stakeholders regarding all aspects of disease, product, and therapy relevant to promotional strategy. You will build a strong advocacy of Novo Nordisks portfolio with key external stakeholders through ongoing/robust scientific interactions. Qualifications MBBS/ MD in Pharmacology from a reputed institution. You shall have strong scientific knowledge and interest in diabetes and obesity including both the therapy area and the products, good collaboration with internal and external stakeholders as well as good communication and negotiation. Strong analytical capabilities, with demonstrated experience in analyzing complex situations. Skills for planning, execution, and follow-up are required, with a creative and innovative attitude that will enable you to drive initiatives with operational excellence and strive towards working with both operational as well as more judicious tasks.

Job Description : Hospitalstore is seeking a talented and creative Content Writer to join our team. The ideal candidate will have experience in writing blog posts, articles, and content pieces that engage and inform our target audience. If you have a passion for writing and can create compelling content, wed love to hear from you! Key Responsibilities: Write and edit blog posts, articles, and web content related to healthcare, medical products, and industry trends. Write scripts for our social media videos. Research and develop content that is informative, engaging, and optimised for SEO. Collaborate with the marketing team to create content for email campaigns, social media, YouTube videos and product descriptions. Ensure all content is consistent in terms of style, quality, and tone of voice. Stay updated with industry trends to produce relevant and timely content. Proofread and edit content for grammar, clarity, and accuracy. Qualifications and Skills Required : 1-2 years of proven experience as a Content Writer, Blogger, or similar role. Strong writing and editing skills with a portfolio of published articles or blog posts. Knowledge of SEO best practices and content optimisation. Ability to conduct thorough research on industry-related topics. Excellent time management and organisational skills. Bachelors degree in English, Journalism, Marketing, or a related field.

Role & responsibilities As a Project Executive (Content Writer) at Cognus Technology, you will play a key role in crafting high-quality, well-researched academic content specifically in the Finance and Medical domains. Youll be responsible for understanding client requirements, conducting in-depth research, and delivering original, insightful content aligned with academic standards. This role is ideal for candidates with a passion for research, strong analytical thinking, and the ability to simplify complex concepts into clear, structured academic documents. Key Responsibilities: Research & Content Creation: Conduct comprehensive research on topics related to Finance and Medical domains. Create clear, structured, and academically sound content tailored to client briefs. Project Management: Handle multiple writing projects efficiently while adhering to deadlines and maintaining content quality. Quality Control: Review, revise, and proofread content to ensure it meets academic standards, includes proper citations, and is plagiarism-free. Client Communication: Interact with clients to gather project requirements, clarify expectations, and provide regular updates. Guideline Adherence: Ensure all work aligns with internal quality benchmarks and academic writing norms. Team Collaboration: Work closely with editors and fellow writers to enhance content quality and meet client satisfaction. Preferred candidate profile Strong domain knowledge in Finance or Medical/Pharma . Excellent research and analytical abilities. Impeccable written English with a focus on academic tone and structure. Time management skills to handle multiple projects. Keen eye for detail and accuracy in writing. Benefits: Dynamic, collaborative work environment Continuous professional development Flexible working hours Supportive team culture Gaming Zone for breaks and recreation In-house Cafeteria

As a Medical Writer II specializing in QC of Regulatory Documents at Syneos Health, you will be responsible for compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately. Your role will involve working within and across departments with minimal or moderate supervision to complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and more. You will adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures, while completing medical writing projects on time and within budget. Additionally, you will coordinate quality and editorial reviews, manage source documentation, and act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format of documents. In this role, you will interact with clients, department heads, and peers to produce high-quality writing deliverables. You will conduct online clinical literature searches, propose solutions to document issues, mentor less experienced medical writers, and maintain a strong working knowledge of drug development processes, regulatory guidelines, and industry best practices. The ideal candidate for this position should have a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and the AMA Manual of Style is desired. In this dynamic role at Syneos Health, you will have the opportunity to contribute to the development of innovative therapies and make a meaningful impact on patient lives. If you are passionate about translating clinical insights into tangible outcomes and thrive in a collaborative and fast-paced environment, we invite you to join our team and be part of a global organization committed to customer success and employee well-being.,

The position of Medical Writer II (Narrative Writing) at Syneos Health involves compiling, writing, editing, and coordinating medical writing deliverables that clearly and accurately present scientific information. Working within and across departments with minimal or moderate supervision, the Medical Writer completes various documents such as clinical study protocols, patient narratives, investigator brochures, informed consents, journal manuscripts, and presentations for scientific meetings. Adherence to established regulatory standards, including ICH E3 guidelines, company SOPs, and client standards is crucial to ensure timely and budgeted completion of medical writing projects. Key responsibilities of the role include coordinating quality and editorial reviews, managing source documentation, acting as a peer reviewer for internal teams, reviewing statistical analysis plans, and interacting with clients and peers to produce high-quality writing deliverables. The Medical Writer mentors less experienced writers, maintains a strong knowledge of drug development processes and regulatory guidelines, and performs online clinical literature searches while complying with copyright requirements. The ideal candidate for this role should hold a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and extensive knowledge of English grammar are essential. Additionally, the candidate should be well-versed in the AMA Manual of Style. Syneos Health is committed to developing its employees through career progression, supportive management, training programs, peer recognition, and a total rewards program. The company fosters a Total Self culture that values authenticity and diversity of thoughts, backgrounds, and perspectives to create an inclusive work environment where everyone feels they belong. By joining Syneos Health, employees have the opportunity to work in a collaborative and innovative setting dedicated to accelerating the delivery of therapies and changing lives. For more information about Syneos Health and its impact in the healthcare industry, please visit http://www.syneoshealth.com. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive, and the company reserves the right to assign additional responsibilities at its discretion. Equivalent experience, skills, and education will also be considered in evaluating candidates for the position. The language used in this description complies with all obligations imposed by relevant legislation, including the Americans with Disabilities Act.,

Job Overview Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree Bachelors Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree Bachelors Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate

Job Overview Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 3 - 4 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet and our enterprise. Making animals lives better makes life better join our team today! Company Overview: At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet, and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals lives better makes life better join our team today! Your Role: [Associate/ Senior Associate Manager Aggregate Report Writing] As an Associate/ Senior Associate Manager Aggregate Report Writing, you will be part of Global Pharmacovigilance team to deliver veterinary pharmacovigilance documents for regulatory submission and internal use. The purpose of this role is to ensure the provision of comprehensive, high quality, scientifically accurate and consistent medical information in consultation with the Global Pharmacovigilance team. Your Responsibilities: Author/review of routine regulatory documents including, but not limited to aggregate reports (PSURs, PDER), Annual Signal Management Reports, and literature searches and occasionally other regulatory documents such as Risk Management Plan, Benefit-Risk Evaluation reports and Ad hoc PSURs required in accordance with applicable regulatory requirements. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Support Regulatory Affairs team in the timely submission of Regulatory dossier for the initial or renewal of product registrations. Maintaining and completing Veeva Vault RIM tasks on time. Collaborate with regulatory affairs, quality assurance, and clinical teams to gather relevant data and ensure consistency. Liaise with global affiliates, and regulatory authorities when necessary. Ensure documentation and processes are audit-ready and support regulatory inspections when applicable. Participate in training and continuous improvement activities related to pharmacovigilance and PSUR processes. What You Need to Succeed (minimum qualifications): Education : i. e. Graduation in veterinary medicine/ post-graduation in pharmacy or any other life science background. Experience : A minimum of 3 - 5 years of industry experience in PV or medical writing. Excellent oral and written communication skills with ability to communicate logically and technically with global stakeholders. High competency in Microsoft Office applications. In-depth knowledge of GxP requirements and regulatory guidelines with sound understanding of operational Regulatory and R&D principles. What will give you a competitive edge (preferred qualifications): Ability to work independently or as part of a team and collaborate with global teams cross geographies and time zones. Experience with electronic document management systems (e. g. , Veeva Vault), Mastery of templates, styles, and submission-ready formatting. Additional Information: Travel percentage up to 10%, annually. Location: IN, Bangalore - Hybrid Work Environment Don t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but dont necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 4 - 6 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

Job Overview Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure. Essential Functions Serve as a stand-alone global lead for aggregate reporting, signal management, or literature survellance projects. Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings and author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to conduct ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data &/or signal detection relevance review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee/set-up and update products signaling strategies. Oversee/author and/or QC review all types of signal management deliverables. Oversee/conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections. In a PV support role, act as functional lead and oversee/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Provide training to SARA staff for qualification on SARA deliverables May perform quality check of all assigned SARA deliverables be responsible for the quality of the final SARA deliverable to client regulatory, IQVIA regulatory reporting (RR), and regulatory authorties. Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables. Act as mentor to and coach to project team staff and direct line reports. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), Business development (BD) and Proposals, and Information Technology (IT), as needed Participate in internal and external audits, as required. Lead audit preparation activities in advance to audit and ensure audit readiness of project Review project files and contact lists on a regular basis to ensure compliance with SOPs Lead functional team and contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Ensure Good Documentation Practices (GDP). Serve as the interface between the global project lead and the working team conduct regular lessons learnt with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Contribute to resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions. Build a positive, collaborative team environment with SARA team members, lead by example and provide training and mentoring for local project leads and less experienced team members. Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies. Participate in the review of existing standard operating procedures (SOPs). Proactively identify issues and propose solutions. Provide consultative guidance to internal and external stakeholders for all SARA deliverables. Suggest, drive, and implement continuous process improvements across all SARA center services. Collaborate with line managers to resolve project performance related issues of staff. Qualifications Bachelors Degree in a Scientific or Healthcare discipline Req 4 - 6 years relevant work experience pref. Equivalent combination of education, training and experience. Req Extensive knowledge of Lifecycle Safety processes, audit practices, governing safety legislation/regulation. Advanced willingness to increase knowledge across IQVIA Safety service lines and develop new skills. Advanced Extensive knowledge of applicable global, regional, local regulatory requirements. Advanced i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Advanced Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Advanced Strong organizational and time management skills. Advanced Proven ability to follow instructions/guidelines, work independently and own initiative(s). Advanced Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Advanced Excellent understanding of operational metrics, productivity and initiatives. Advanced Excellent project management, leadership, and mentoring skills. Advanced Excellent presentation and customer-focused skills. Advanced Excellent judgment, decision-making and problem solving skills. Advanced Encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives. Advanced . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure. Essential Functions Serve as a stand-alone global lead for aggregate reporting, signal management, or literature survellance projects. Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings and author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to conduct ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data &/or signal detection relevance review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee/set-up and update products signaling strategies. Oversee/author and/or QC review all types of signal management deliverables. Oversee/conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections. In a PV support role, act as functional lead and oversee/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Provide training to SARA staff for qualification on SARA deliverables May perform quality check of all assigned SARA deliverables be responsible for the quality of the final SARA deliverable to client regulatory, IQVIA regulatory reporting (RR), and regulatory authorties. Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables. Act as mentor to and coach to project team staff and direct line reports. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), Business development (BD) and Proposals, and Information Technology (IT), as needed Participate in internal and external audits, as required. Lead audit preparation activities in advance to audit and ensure audit readiness of project Review project files and contact lists on a regular basis to ensure compliance with SOPs Lead functional team and contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Ensure Good Documentation Practices (GDP). Serve as the interface between the global project lead and the working team conduct regular lessons learnt with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, statement of work (SOW) changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Contribute to resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions. Build a positive, collaborative team environment with SARA team members, lead by example and provide training and mentoring for local project leads and less experienced team members. Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies. Participate in the review of existing standard operating procedures (SOPs). Proactively identify issues and propose solutions. Provide consultative guidance to internal and external stakeholders for all SARA deliverables. Suggest, drive, and implement continuous process improvements across all SARA center services. Collaborate with line managers to resolve project performance related issues of staff. Qualifications Bachelors Degree in a Scientific or Healthcare discipline Req 4 - 6 years relevant work experience pref. Equivalent combination of education, training and experience. Req Extensive knowledge of Lifecycle Safety processes, audit practices, governing safety legislation/regulation. Advanced willingness to increase knowledge across IQVIA Safety service lines and develop new skills. Advanced Extensive knowledge of applicable global, regional, local regulatory requirements. Advanced i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Advanced Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Advanced Strong organizational and time management skills. Advanced Proven ability to follow instructions/guidelines, work independently and own initiative(s). Advanced Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Advanced Excellent understanding of operational metrics, productivity and initiatives. Advanced Excellent project management, leadership, and mentoring skills. Advanced Excellent presentation and customer-focused skills. Advanced Excellent judgment, decision-making and problem solving skills. Advanced Encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives. Advanced

Role & responsibilities - Medical Transcriptionist, Medical Typist cum receptionist Preferred candidate profile - Hospital Background with Typing experience Contact on 7506252662

You should have MBBS/PhD/MDS/BDS/MPharm/PharmD education qualification with 10 to 12 years of experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5). As a Medical Writer, your role will involve handling complex Medical Writing projects, providing review support for medical writing deliverables, training junior writers, and authoring a broad set of different clinical document types that support regulatory filings. You should have demonstrated excellence in focused/lean writing, lead cross-functional teams, understand the clinical development process, and possess effective communication, time management, organizational, and interpersonal skills. People management experience for more than 2 years is required along with the ability to work independently while maintaining communication with the Sponsors MW project manager. Your responsibilities will include preparing/reviewing clinical study reports, protocols, investigator brochures, submission documents, and other regulatory documents on investigational drugs in various stages of clinical development. You will apply lean authoring principles, coordinate document review activities, develop project plans, and work as an active member of cross-functional teams representing Medical Writing. Conducting literature searches, participating in department initiatives, researching regulatory requirements, and ensuring compliance with company training are also part of your responsibilities. You should have strong knowledge of regulatory guidelines/requirements, the ability to interpret data, apply scientific knowledge to support regulatory document writing, manage messaging for consistency, and provide insight based on previous experiences. Additionally, expertise in MS Word, document management systems, eApproval/signatures, and adaptability to new tools and technology are required. Capable of training writers/authors on the use of templates, guidelines, and tools is also essential for this role. This position is based in Bangalore, KA, IN.,

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. You will review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Collaboration with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs will be essential to produce high-quality writing deliverables. You will also serve as a peer reviewer to ensure scientific content accuracy, clarity, overall consistency, and proper format. Adherence to established regulatory standards, including ICH-E3 guidelines, Company Standard Operating Procedures, and client standards is paramount. Your role will involve performing online clinical literature searches, maintaining a working knowledge of the drug development process and regulatory guidelines, and continuing professional development to stay informed about regulatory guidance affecting medical writing. In this role, you will be expected to work within budget specifications for assigned projects and communicate any changes to medical writing leadership promptly. Completing required administrative tasks within specified timeframes and performing other work-related duties as assigned will be part of your responsibilities. Some minimal travel may be required, typically less than 25%. To qualify for this position, you should have a Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree in Social Sciences, English, or Communications with scientific and/or medical knowledge. Proficiency in English grammar, FDA and ICH regulations, and familiarity with AMA style guide is necessary. Effective presentation, proofreading, interpersonal, and leadership skills are essential for this role, along with a team-oriented approach. If you are passionate about making a meaningful impact in the field of medical writing and are eager to contribute to the development of cutting-edge therapies, Syneos Health offers a dynamic and supportive work environment where your contributions will be valued and recognized. Join us in our mission to accelerate customer success and transform lives through innovative medical writing practices.,

Job Title: Medical Data Abstractor (MDA) Department: Delivery Job Location: Turbhe, Navi Mumbai (Work from Office) Reporting To: Lead Job Duties / Responsibilities: Data management and Curation Performs complex data abstraction (i.e. requiring interpretation) and data entry for specified disease and project requirements. Participates and contributes to team meetings and learning sessions. Maintains a high level of medical knowledge and terminology and expertise of electronic medical record and data capture systems. Self-reports activities like time spent on records, audits completed including all relevant details and any other reporting functions assigned by Operations and QA management teams. Quality Assurance Consistently complies with minimum quality levels indicated in the QA plan for each project (>95% or higher accuracy depending on the project). Receives feedback from Quality Analyst and ensures timely reconciliation of errors. Participates in quarterly Inter rater reliability (IRR). Special Projects May lead or participate in special projects or client-specific initiatives as directed. Education and Experience: Graduate / PG - Medicos: BDS, MDS, BAMS, BUMS, BHMS, BPT, MD. 0-5 years of experience in the clinical or non-clinical field. Should be presentable and pleasant. Ability to multitask, work under pressure, and meet deadlines required.,

As a Clinical Evaluation Medical Writer at Medtronic, you will play a crucial role in developing and updating clinical evaluation documents to support CE Mark submissions and ensure compliance throughout the product lifecycle. Your work will involve close collaboration with cross-functional teams to gather and interpret data on device safety, performance, and benefit-risk according to MEDDEV 2.7/1 Rev. 4 and EU Regulation 2017/745. You will also be responsible for summarizing and disseminating clinical literature and other available data to share relevant evidence, while managing Medical Information activities. This includes tracking inquiries, monitoring key metrics, researching and responding to technical and clinical questions from internal teams and external healthcare professionals under the guidance of Clinical and Medical Affairs. Success in this role will require strong skills in scientific writing, literature review, data analysis, and clear communication, as well as a proactive and collaborative mindset. Your responsibilities may include independently creating and maintaining clinical evaluation documents in compliance with relevant regulations and company procedures, supporting Medical Information activities by responding to inquiries, conducting literature searches and reviews, reviewing scientific materials for accuracy and compliance, developing reports, identifying and reporting complaints or adverse events, and collaborating with key stakeholders to drive evidence-based scientific decisions. To excel in this position, you are required to have a mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. A Baccalaureate degree and a total of 8 years of experience with a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience are also required. Medtronic offers a competitive salary and flexible benefits package as part of its commitment to employees. The company values the contributions of its employees and offers various benefits, resources, and competitive compensation plans designed to support you at every career and life stage. The position is also eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). Medtronic is a global leader in healthcare technology that aims to address the most challenging health problems facing humanity by seeking out innovative solutions. With a mission to alleviate pain, restore health, and extend life, Medtronic unites a global team of passionate individuals who are committed to making a difference. The company values diversity and is dedicated to engineering extraordinary solutions for real people by leveraging talent, diverse perspectives, and ambitious ideas. To learn more about Medtronic's business, mission, and commitment to diversity, please visit their website.,

Role & responsibilities: Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Preferred candidate profile : Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred 5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Med& Scientific Writing, Regulatory Ser. Experience: 3-5 Years.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma). Experience: 1-3 Years.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Med& Scientific Writing, Regulatory Ser. Experience: 1-3 Years.

Summary Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. About the Role Job Title: MSL Manager #LI-Onsite Location: Mumbai, India Key Responsibilities Build and maintain scientific relationships with Medical Experts to support strategic engagement. Identify and map key accounts and experts aligned with medical priorities. Develop and execute engagement plans tailored to country-specific strategies. Respond to unsolicited medical inquiries with accurate, up-to-date scientific information. Support clinical trial execution and site education in collaboration with clinical operations. Facilitate Investigator Initiated Trial (IIT) processes upon investigator request. Act as a scientific resource for internal field teams and cross-functional partners. Ensure timely reporting of adverse events and technical product complaints. Essential Requirements Proven experience in operations management and cross-functional collaboration. Strong understanding of clinical research and medical affairs processes. Proficiency in scientific communication, including medical writing and data interpretation. Familiarity with CRM tools and digital platforms for stakeholder engagement. Knowledge of disease management, drug development, and epidemiology. Ability to analyze and present clinical data effectively. Fluency in English, both written and spoken. Desirable Requirements Prior experience in a Medical Scientific Liaison or similar field-based medical role. Advanced degree in life sciences (e.g., MD, PhD, PharmD) preferred.

Summary The Medical Expert in TCO (Translational Clinical Oncology) is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical co-leadership for assigned aspects of one or more global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) TCO (Translational Clinical Oncology) is a department under Biomedical Research division, and is responsible for designing and executing out early phase (first in human) clinical studies in patients with cancer. It acts as a bridge between drug discovery and late phase clinical development and strives to deliver transformative new medicines for oncology conditions. About the Role Major accountabilities: Provides medical support to Clinical Program Leader (CPL) leading the program. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (e.g., Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. May represents CPL at project team meetings (e.g. CTT) and may provide inputs to project strategy May represent CPL at Investigator teleconferences including dose escalation meetings and site initiation visits. Oversees the clinical/scientific elements of TCO related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc. Leads the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Manages stakeholder engagements internally and externally Mentors and coaches junior TCO team members in India Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Leads or assists with relevant trainings across TCO India Advocate continuous improvement of quality Ensure all activities of associates comply with company standards and local regulations Key performance indicators: Management of assigned studies to ensure execution according to timelines, and with high quality, ensuring adherence to international and local regulations. Demonstrates excellent scientific writing skills to enable the development of quality trial reporting, and regulatory documents. Strong evidence of quality medical review of trial data and quality contributions to clinical sections of e.g. protocols, IBs, DSURs and CSRs Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements: Education: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required. Experience in hematology / oncology preferred Work Experience: At least 5 years of pharmaceutical/biotech industry experience At least 2 years of clinical practice experience in the hospital setting. Experience with oncology clinical trials Experience with early development clinical trials Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects. Strategic thinking: ability to network with and influence key stakeholders, clear and logical presentation of complex strategic issues. Clear written and verbal expression of ideas, an active/proactive communicator. Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Medical Strategy. Regulatory Compliance. Languages : English. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Summary To manage and complete assigned Medical Communications deliverables at high quality standards and in accordance with agreed timelines. Projects include manuscripts, abstracts, posters, slide sets, satellite symposia content, congress or advisory board reports, publication planning and medical education materials for internal medical and/or clinical teams. About the Role Location Hyderabad #LI Hybrid Major Responsibilities: Demonstrate a command of assigned therapeutic areas and expertise with assigned products. Research and write original content for publications activities (primary and review manuscripts, abstracts, posters), slide presentations and other materials based on direction and materials supplied by customers. Prepare meeting materials for satellite symposia (agenda, slide content, speaker briefings etc), and reports from advisory boards and other internal or external meetings. Develop content that is scientifically accurate, evidence-based, grammatically accurate, referenced using appropriate sources, and consistent with quality standards for author review, customer review as appropriate, and scientific peer review. As needed, perform quality control (QC) checking / proof reading of the above-mentioned documents to meet customer expectations. Clearly communicate medical scientific concepts in a condensed, audience-appropriate way. Follow all internal processes and procedures with regard to workflow, development of deliverables, and adherence to industry best practices, including GPP3. Demonstrate the flexibility/adaptability necessary to function on different therapeutic teams as needed and to work on projects across multiple brands at any given time. Interpret and apply clinical data in medical communication deliverables. Work in conjunction with service team and line manager to develop and adhere to logical and attainable timelines for project completion. Provide input and aid in troubleshooting / problem-solving. Collate and incorporate author/customers comments. Lead and/or participate in author/client teleconferences. Provide accurate citations in text (utilizing Reference Manager system), a bibliography, and appropriately annotated references for medical review. Participate in strategic and tactical publications planning and related research. Work as part of a team; train new colleagues as and when required. Supports people and performance management. Maintains records for all assigned projects including archiving. Maintains audit, SOP and training compliance. Performs additional tasks as assigned. Minimum Requirements: Education: Minimum: Minimum science degree or equivalent. Desirable: MSc, PhD, PharmD, or MD. Work Experience: Minimum of 5 years experience in medical communications. Medical writing experience. Good understanding of industry work processes for publications. Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook). Why Novartis: Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve thisWith our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https: / / www.novartis.com / about / strategy / people-and-culture You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: 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 Description The Commercial Campaigns Editor (CCE) will drive successful digital campaigns by ensuring the creation of high-quality content that engages healthcare professionals across commercial campaigns. The CCE will ensure campaigns are executed with precision, adhering to editorial standards, brand voice and strategic goals, resulting in measurable success for both the brand and clients. Essential duties and responsibilities: Including, but not limited to, the following: Proofreading and copyediting Review copy documents, HTML web pages and PDFs for spelling, punctuation, syntax, clarity and accuracy, ensuring the production of high-quality content tailored for various platforms, including digital, social media and print Ensure all content aligns with brand voice and messaging, and maintain consistency and accuracy across copy, build and amends stages Apply UX principles to content development, ensuring that all materials are user-friendly, accessible and designed to enhance the audiences journey through clear and engaging storytelling Quality assurance Maintain and uphold editorial guidelines, house style and best practices across commercial campaigns, including adherence to industry compliance standards Support the Senior Editorial and Quality Manager to continuously review and strengthen editorial processes Communication Collaborate and communicate with cross-functional teams, including Medical Writing and Design Qualifications Editorial expertise strong understanding of editorial processes, style guides and content creation best practices Attention to detail meticulous in reviewing content to ensure accuracy, clarity and a