543 Medical Writing Jobs - Page 3

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply

Role & Responsibilities: Develop and author clinical evaluation deliverables such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) plans/reports, Post-Market Clinical Follow-up (PMCF) plans/reports, and Summary of Safety and Clinical Performance (SSCP) reports, in strict compliance with EU MDR 2017/745 and relevant global regulatory standards. Critically evaluate and synthesize clinical evidence from various sources including clinical investigations, scientific literature, PMS/PMCF data, and registries. This includes reviewing medical literature, analysing clinical risks, and providing comprehensive benefit-risk assessments for medical devices. Collaborate cross-functionally with teams in Regulatory Affairs, R&D, Quality Assurance, Sales, and Marketing to ensure alignment on clinical evaluation project deliverables and support product development, approval, and post-market activities. Review and provide feedback on Instructions for Use (IFUs), patient guides, clinical study protocols, and clinical investigation reports to ensure consistency and compliance with regulatory requirements. Manage responses to regulatory authorities (e.g., Notified Bodies and Competent Authorities), addressing complex queries related to clinical evaluations and ensuring compliance with EU MDR and other regulatory frameworks. Ensure quality and integrity of documentation, maintaining attention to detail, consistency, and adherence to regulations such as ISO 13485, ISO 14155, MEDDEV 2.7/1 Rev 4, and EU MDR 2017/745. Support regulatory submissions by providing clinical evidence for product approvals, indication expansions, and ensuring compliance with post-market surveillance and clinical follow-up obligations. Stay current with global regulations and standards, including MDR, MEDDEV, and ISO, and effectively communicate the implications of evolving regulatory landscapes to internal stakeholders. Requirements: Advanced degree in life sciences, biomedical engineering, or a related medical/scientific discipline. 4 to 5 years of experience in clinical evaluation, medical writing, or a related role in the medical device industry, with a focus on clinical evaluation documentation Proven experience in medical writing, with a strong focus on clinical evaluation documentation for medical devices. In-depth knowledge of EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, and relevant ISO standards (ISO 13485, ISO 14155). Excellent ability to critically appraise clinical data and present well-organized, scientifically sound reports. Strong technical and medical writing skills, with an ability to convey complex information clearly and concisely. Experience with regulatory submissions and addressing Notified Body/Competent Authority queries is a plus.

As a Medical Writer with our dynamic team, you will utilize your expertise in writing, editing, and reviewing scientific and medical content. Your primary responsibility will involve transforming intricate medical data and research findings into clear, accurate, and engaging documents suitable for various audiences, including healthcare professionals, regulatory bodies, and the general public. You will be expected to develop, write, and edit a diverse range of documents such as clinical study reports, regulatory submission documents, peer-reviewed publications, and educational materials. Your role will also involve generating high-quality manuscripts, abstracts, posters, and presentations for scientific conferences, journals, and other platforms. Collaboration is key in this role as you will work closely with researchers, clinicians, regulatory affairs professionals, and other stakeholders to ensure that all content aligns with regulatory standards, maintains scientific accuracy, and supports corporate objectives. Additionally, you will be responsible for preparing and revising documents for regulatory submissions, ensuring compliance with guidelines from regulatory bodies such as FDA, EMA, and ICH. Your tasks will also include conducting literature searches, reviewing existing medical research, and ensuring the accuracy and relevance of information to support content development. Quality assurance is crucial as you will be editing and proofreading content for clarity, consistency, accuracy, grammar, and adherence to style guides. Project management skills are essential as you will be managing timelines for multiple projects to ensure timely and efficient completion of tasks. Compliance with medical, ethical, and regulatory standards is a core requirement for this role. To qualify for this position, you should hold a degree in BAMS, BDS, MBBS, or Pharm D, along with a minimum of 2 years of experience in medical writing, medical coding, or a related field. Experience with regulatory documents is highly preferred. A strong understanding of clinical research, medical terminology, and regulatory guidelines is essential. Proficiency in Microsoft Office Suite, reference management software, and medical writing software is required. Excellent written and verbal communication skills are essential, with the ability to convey complex information clearly and concisely. Strong attention to detail, collaboration skills, and the capability to work independently and as part of a team in a fast-paced environment are also necessary. Exceptional command of the English language is required, and knowledge of additional languages is a plus. Desirable skills for this role include experience with writing for regulatory agencies, familiarity with scientific publishing and journal submission processes, knowledge of Good Clinical Practice (GCP), and experience with statistical analysis and interpretation of clinical data. This is a full-time, permanent position with benefits including provided food, health insurance, and Provident Fund. The work schedule is a day shift with a fixed location in person. The application deadline is 31/07/2025.,

: Prepare and maintain the Signal Schedule as per Standard Operating Procedures. Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product. Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet. Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures. Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders. Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal detection. Maintain awareness on new or revised regulatory requirements and guidelines relevant to Signal Management. Ensure regulatory compliance (quality, procedures, regulations, timeliness, consistency) for Signal Management process. Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning Signal Management. Impart trainings related to Signal Management activities, as and when required Skills Required: Regulatory Medical Writing | Intermediate Medical Literature Review & Analysis | Intermediate Adverse Event Reporting & Signal Detection | Advanced Regulatory Affairs Collaboration | Intermediate Safety Data Analysis & Visualization | Advanced

What We Want You To Do Analyze and manage the NGS / Nanopore data using relevant pipelines. Develop customized pipelines and workflows and tweak current pipeline filters for NGS and Nanopor analysis Help in developing and executing various data management strategies Identify the databases, tools, catalogs, and their reliability in future and help the research team in data collection strategies. Interpret genetic sequence variations identified through the pipelines Check quality and accuracy of the data Work in conjunction with team members to ensure consistent result generation Work in conjunction with wet lab and tech teams to ensure smooth operations and development work Troubleshoot issues related to data analysis tools and software Review literature for new technologies in the field of Bioinformatics Write grants and papers in the company Creating documentation and maintaining it What Are We Looking In You PhD in Genetics/Genomics or related fields or 8+ years of experience in the field of human genomics/genetics Experience with building bioinformatics pipelines for various kinds of NGS data Assisting in drafting and completing manuscripts for publication Experience with handling various different databases and tools Perform statistical analysis on the datasets Comfortable working on Linux OS system Ability to read, interpret and curate scientific literature Excellent communication skills (oral and written) and attention to detail Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow, instructions, complete deadlines, and comply with company policies Experience of 1-2yrs+ in Python & experience of 3-5 yrs in Bash scripting Experience with pipeline orchestration tools (Nextflow or Snakemake) will be a bonus Skills: pipelines,pipeline orchestration tools (nextflow, snakemake),python,genomics,communication skills,bash scripting,ngs data analysis,linux,quality control,bioinformatics pipeline development,ngs,nanopore data analysis,genetics,literature review,bioinformatics pipelines,linux os,pipeline orchestration tools (nextflow or snakemake),grant writing,statistical analysis,genetic sequence interpretation,scientific literature interpretation,human genetics,bioinformatics,data management strategies,pipeline

Project Name:- Implementation Research for optimizing the comprehensive sickle cell Anemia (SCA) care services under the National SCA Elimination Mission " Name of the Post :- Project Research Scientist-II ( Medical) No. of Vacancy :- 01 (One Post) Emoluments :- 80,000/+ 10% HRA Essential Qualification :- Professionals with MBBS/BDS/BVSc with 3 years post qualification experience MBBS/BDS/BVSc with + Post Graduate degree (MD/MVSC/MDH/MPH) or any equivalent degree including integrate PG degrees. MBBS/BDS/BVSc with PhD Desirable Qualification:- Education in public health background is preferred. Previous experience in programe implementation knowledge of sickle cell anemia policy, implementation research. Age limit :- Not exceeding 40 years Location :- ICMR-CRMCH, Chandrapur Duration :- Up to 3 years (Duration of Project) Please share your cv on this mail id Anchal.g@esolglobal.com.

Let s do this. Let s change the world. The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Aster Medcity is looking for Specialist.Emergency Medical Services to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistants, specialists, therapists, and other medical staff. Advising patients, parents, and guardians on diets, activities, hygiene, and disease prevention. Conducting research and remaining up to date on current trends, discoveries, and developments in the field

Specialist Regulatory Affairs LCM - Strategic Growth Products Date: 14 Jul 2025 Location: Andheri (East), IN, Mumbai 400 Company: AdvanzPharma Location: Andheri, Mumbai (Hybrid working opportunity) About ADVANZ PHARMA ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. About Business Unit The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. What You ll Do: Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as well become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Renewal Application and Annual Maintenance Variation Application Notification of Change in Marketing Status, sunset clause exemptions where applicable Notification of drug shortages Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Orphan Designation Maintenance (where applicable) Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Innovative Medicines (but may as well extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc. for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through MA will not sit with this role, however, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Formal training in Regulatory Knowledge, Skills Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Medical writing and Review experience Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently Well versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines post approval changes such as PIP modifications and label expansions. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. Why ADVANZ PHARMA The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you ll be empowered to own your work, explore new possibilities, and make things happen. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

Experience:2 to 4 years of exp. in Scientific or Medical Writing, and/or Quality and regulatory experience in post market surveillance. Exp. with medical device, orthopedic or trauma devices preferred. Required Candidate profile Education B. Tech / B.E in a field related to the life sciences or a relevant medical engineering field (biology,physiology,biomaterials, biomedical engineering or similar). Desired Skills:PMS,EU MDR

Role & responsibilities To prepare protocol preparation Incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same. To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable. To Prepare of the CRFs and other working documents, if applicable. To prepare documents for submission to the regulatory. Internal QC of study documents Literature Search To assist the Project Manager for feasibility assessment of study proposal. Literature survey for PK & Safety study Co-ordination with Principal Investigator (PI) and/or Clinical Investigator (CI) for application. To prepare documents for submission to the Ethics Committee (EC).

As a Professor of Biochemistry at Dr. Moopens Medical College, you will play a crucial role in delivering quality education and healthcare services at our Wayanad campus. With a strong educational background in Biochemistry or a related field, along with a minimum of 7 years of professional experience, you will be responsible for imparting knowledge and mentoring students in the field of biochemistry. Your responsibilities will include delivering high-quality lectures and laboratory sessions to both undergraduate and postgraduate students. Additionally, you will be expected to develop and update the curriculum to align with the latest advancements and standards in biochemistry. Supervising and mentoring students in their research projects, as well as participating in departmental meetings and academic councils, will be essential aspects of your role. You should possess excellent medical writing skills for publication in reputed journals, as well as competence in patient care and clinical biochemistry practices. Your deep understanding of biochemistry principles and laboratory techniques will be invaluable in contributing to the body of knowledge in the field. Adhering to National Medical Commission (NMC) norms and guidelines, along with institutional policies, will be crucial to ensure compliance and quality in your work. Furthermore, your ability to communicate effectively and work collaboratively in a multidisciplinary team will be key to your success in this role. Engaging in continuous professional development activities to stay updated on the latest advancements in the field will also be expected of you. If you are dedicated, experienced, and passionate about biochemistry education and healthcare, we encourage you to apply for this senior-level position and be a part of our committed team at Dr. Moopens Medical College.,

You will be joining Wellness Extract, a prominent healthcare company headquartered in Canada, in the role of a Senior Content Writer. Your primary responsibility will be to create high-quality healthcare-related content, including articles, blog posts, website copy, social media posts, and marketing materials. It is essential that you have prior experience in writing scientific blogs at a medical level. To excel in this role, you must possess a comprehensive understanding of healthcare topics, trends, and terminology to ensure the accuracy and relevance of all content. Utilizing best search engine optimization (SEO) practices will be crucial to enhance the visibility and ranking of the content on search engines. Collaboration with the marketing team will be necessary to develop content strategies that align with overall marketing goals and initiatives. Your content should be tailored to resonate with the target audience, driving engagement, interaction, and brand loyalty. Upholding high standards of quality, accuracy, and compliance with company policies and industry regulations will be paramount. Staying updated on industry developments, emerging trends, and competitor activities will be essential to enhance the effectiveness and relevance of the content continually. You will work closely with cross-functional teams, including marketing, design, and product development, to ensure content alignment and consistency across all channels. The ideal candidate will hold a Bachelor's degree in English, Journalism, Communications, or a related field, along with at least 3 years of proven experience as a Content Writer, preferably in the healthcare industry. Your role will require exceptional writing, editing, and proofreading skills, with a keen attention to detail. A strong grasp of SEO principles and best practices will be necessary, along with the ability to translate complex healthcare topics into clear, concise, and engaging content. Creative thinking and problem-solving skills will also be key attributes for success in this position.,

As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specifications, attend project meetings, stay updated on regulatory guidance, maintain Aggregate Report Tracker, perform detailed searches on regulatory agency websites, mentor associates, and provide effective communication that leads to operational excellence. To qualify for this role, you should have a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience. An advanced degree is preferred, along with previous experience in the pharmaceutical/CRO industry. Additional qualifications in medical writing (AMWA, EMWA, RAC) would be advantageous. You should possess excellent data interpretation and medical writing skills, strong project management abilities, interpersonal and negotiation skills, and exceptional oral and written communication skills. Knowledge of global, regional, and national document development guidelines, along with proficiency in Microsoft Word, PowerPoint, and Excel, is essential. You should be able to work well in a team, handle pressure, and deliver quality work within tight timelines. Occasionally, you may need to work in different time zones. This position does not have any direct reports and is based in Gurgaon. If you meet the qualifications and possess the required skills and abilities, we invite you to apply for this challenging and rewarding role in the medical-regulatory writing field.,

As a Medical Writer at our organization, your primary responsibility will be to write, review, and manage the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Additionally, you will provide authoritative documentation-related consultancy to other line functions and coach/mentor less experienced writers as needed. Your major accountabilities will include authoring, reviewing, and managing high-quality clinical and safety documents such as complex Clinical Study Reports (CSRs), Risk Management Plans (RMP), and various submission documents for health authorities. You will lead writing teams for complex submissions, contribute to key messaging and strategy, and ensure compliance with internal company standards and external regulatory guidelines. In this role, you will be an ad-hoc member of Clinical Trial Teams (CTTs) and extended member of Safety Management Teams (SMTs). You will also provide input into planning data analyses and presentations used in various documents. Your expertise in documentation will be crucial in ensuring compliance with standards and guidelines, as well as providing strategic guidance for clinical portions of submissions. You will also be responsible for leading process improvement initiatives, identifying training needs, and fostering a high level of performance within the team. Your ability to communicate effectively, prioritize tasks, and solve complex problems will be essential for success in this role. Additionally, your experience in managing global teams and projects will be valuable in driving organizational and team performance across cultures. At Novartis, we are dedicated to helping people with diseases and their families by combining innovative science with a community of smart, passionate individuals like yourself. If you are ready to collaborate, support, and inspire others to achieve breakthroughs that change patients" lives, we invite you to join our network and create a brighter future together. For more information about Novartis and our commitment to personal and professional growth, please visit our website at [Novartis People and Culture](https://www.novartis.com/about/strategy/people-and-culture). If you are interested in exploring career opportunities at Novartis, please sign up to our talent community to stay connected and be informed about suitable roles as they become available: [Novartis Talent Community](https://talentnetwork.novartis.com/network). To learn more about the benefits and rewards of working at Novartis, please refer to our handbook: [Novartis Benefits and Rewards](https://www.novartis.com/careers/benefits-rewards).,

As a Medical Writer at Novartis Healthcare Private Limited, you will be responsible for writing, reviewing, and managing the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Your role will also involve providing authoritative documentation-related consultancy to other line functions and coaching, mentoring, and training less experienced writers. In this position, you will author, review, and independently manage complex Clinical Study Reports (CSR), Risk Management Plans (RMP), and other documents for health authorities. You will lead writing teams for complex submissions, contribute to key messaging and pooling strategy, and ensure compliance of documentation to internal company standards and external regulatory guidelines. Additionally, you will be an ad-hoc member of Clinical Trial Team (CTT) and extended member of Safety Management Team (SMT). You will provide input into planning data analyses, ensure compliance to internal company standards and external regulatory guidelines, and lead process improvement in cross-functional initiatives. Key performance indicators for this role include delivering high-quality clinical and safety documents in a timely manner and in compliance with internal and external standards, as well as completing an adequate volume of work per year according to Key Performance Indicators. To be successful in this role, you should have at least 6 years of medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge. Expert knowledge of the global regulatory environment, excellent communication skills, and the ability to prioritize and manage multiple demands and projects are essential. You should also have proven experience in managing global, cross-functional teams or complex global projects and the ability to motivate and coach people. At Novartis, we are committed to creating a brighter future by helping people with diseases and their families. We believe in collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients" lives. Join our Novartis Network to stay connected and learn about suitable career opportunities as soon as they arise. If you require any reasonable accommodation due to a medical condition or disability during the recruitment process, please contact us at [email protected] Novartis is dedicated to building an outstanding, inclusive work environment that reflects the diversity of the patients and communities we serve.,

We are looking for a highly motivated and detail-oriented individual to join our team as a Medical Scribe Trainee in the IT Services & Consulting industry. The ideal candidate will have excellent communication skills and be able to work effectively in a fast-paced environment. Roles and Responsibility Accurately and efficiently transcribe medical records with attention to detail. Maintain confidentiality and adhere to HIPAA guidelines when handling sensitive information. Collaborate with healthcare professionals to clarify diagnoses or treatment plans. Develop and implement effective transcription techniques to improve quality and productivity. Participate in ongoing training and education to enhance transcription skills and knowledge. Contribute to the development of high-quality transcripts that meet client expectations. Job Requirements Strong foundation in English language grammar, punctuation, and syntax. Excellent listening and typing skills with a minimum speed of 40 words per minute. Ability to work independently and as part of a team with strong time management skills. Familiarity with medical terminology and concepts, including anatomy and physiology. Strong analytical and problem-solving skills with attention to detail and accuracy. Ability to adapt to changing priorities and deadlines in a dynamic environment.

MedeXCode is looking for Junior Pharmacovigilance Specialist to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistants, specialists, therapists, and other medical staff. Advising patients, parents, and guardians on diets, activities, hygiene, and disease prevention. Conducting research and remaining up to date on current trends, discoveries, and developments in the field

Position Description: The Commercial Learning Services (CLS) Medical Writer is responsible for the development of medical content including but not limited to creating/ updating wireframes, building reference packages, creating/ updating learning content for product trainings for assigned areas at both Global and affiliate level. The CLS Medical Writer will anticipate and adjust for problems and roadblocks, interface with Lilly partners at Indianapolis and Lilly Bengaluru and integrate new business processes where necessary. Using strong adult learning principles, CLS Medical Writer ensures quality design, development, and delivery of training development projects. This role will interact with a wide variety of people both in Lilly Bengaluru and the US, at varying levels of the business The role will report to CLS Group or Team Leader at Lilly Bengaluru. Key Objectives/Deliverables: Medical Writing (Content Development) Partners with learning consultants and business partners to effectively gather and evaluate source content from multiple sources. Plans (including organizing/preparing outlines), write (including first-draft authoring), edit, review, and coordinate the creation of medical learning content (storyboard) Ensures that key content, scientific concepts, elements from internal guidance and resource documents are included appropriately in all learning content, and that all documents are well written, usable/executable, and compliant with policies and procedures. Ensures proper documentation of needed references and attribution of source material. Ensures and coordinates quality checks for accuracy, collate reviewer s comments, adjust content of training as required based on internal/external input, and prepare final version. Drives quality standards through review of project documents, design, deliverables, final learning content and evaluation data. Project and Stakeholder management Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents. Effectively manage multiple projects and exhibit flexibility in moving across therapeutic areas, and products, depending on project assignment. Builds, communicates, and manages credible project timelines. Influences or negotiates changes of timelines and content with other team members. Anticipates and mitigates risks to delivery. Anticipates and resolves project/program issues, escalating as appropriate. Knowledge Sharing and Development Maintains and enhances therapeutic area knowledge including disease state and compound(s) for assigned project(s). Maintains and enhances the medial writing skills to align with the audience needs and with the changes in technology and platforms. Provides coaching to others by sharing technical information, giving guidance, answering questions. Networks with others (including other functions and regions) to identify and share best practices. Contributes to process improvements, suggesting opportunities where appropriate. Basic Requirements: Demonstrated experience in technical scientific writing. Demonstrated excellence with program/project management and time management skills. Successful completion of a writing exercise. Demonstrated ability to establish strong business relationships. Ability to work independently and in a team environment. Demonstrated ability in conflict resolution, judgment and managing complexity. Ability to prioritize work and balance multiple projects simultaneously. Strong work ethic, personal motivation, and team player who is dynamic and result oriented Good presentation skills, interpersonal and communication skills, fluent (verbal and written) in English. Ability to operate effectively in an international matrix environment, with ability to work across time zones. Additional Preferences: Experience writing regulatory, clinical trial documents, publications and/or writing deliverables for Medical Affairs communications (slide decks, patient, or HCP materials, etc.). Experience working in a regulated environment. Experience working with US organizations. Strong organizational skills. Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates). Education Requirements: Bachelor s degree in a scientific, health, communications, technology health related field Other Information: Travel may be required. . .

We are looking for an experienced and dedicated Clinical Pharmacist to join our team The candidate should have a minimum of 1 year of experience Review and evaluate medication orders to ensure appropriateness, safety, and efficacy based on patient-specific factors such as age, condition, and comorbidities Collaborate with physicians, nurses, and other healthcare professionals to develop and implement patient-specific medication therapy plans Monitor patient progress and outcomes to adjust medications as needed Educate patients and caregivers on the proper use, side effects, and interactions of prescribed medications Ensure compliance with established protocols, regulatory requirements, and hospital policies Conduct medication reconciliation during patient transitions of care Participate in clinical rounds and provide drug information and therapeutic recommendations to healthcare teams Maintain accurate and updated patient medication records Assist in formulary management and participate in drug utilization reviews and audits Provide training and guidance to pharmacy staff, students, or residents Ask ChatGPT

Novo Nordisk Global Business Services (GBS), India Department- Centralised Monitoring Unit (CMU)- Bangalore Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers), technical programmers (Functional programmers, statistical monitors) and Medical Illustrators. Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials. Medical Illustrators are responsible for developing engaging visual content for our clinical meetings. The Position As Senior Central Monitor, an ideal candidate will be responsible for providing inputs in defining standard and trial specific key risk indicators and performing ongoing monitoring of operational risks. Ensure both standard and trial specific Key Risk Indicators (KRIs) impacting patient safety and data quality and regulatory compliance are appropriately defined as per protocol, monitoring strategy etc prior to start of centralised operational monitoring review. Responsible to Perform ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives. Provide inputs to applications, databases and systems used to monitor operational data. Responsible for communication and findings of operational review to relevant stakeholders to enable decision making. Act as primary contact for relevant stakeholders and participate in project meetings for assigned centralized monitoring studies . Prior experience with RBQM (Risk-Based Quality Management) and field monitoring as a CRA is desirable. Familiarity with analytical tools is preferred, as well as experience using SAS, Python, R, and SQL. Contribute to discussions around share learnings and practices with wider CMU department colleagues and with other relevant stakeholders Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements. Qualifications Minimum of bachelors degree in life science/scientific or health care discipline. Above 5 years of relevant clinical research experience with good knowledge of drug development process and risk-based quality management principles. Prior CRA/Field Monitoring and analytical tool experience is desirable Skill in aggregate data review and interpretation using visualization/analysis softwares Solid understanding of clinical trial design, trial execution and operations. Ability to successfully manage multiple projects and priorities. Good Communication & Presentation skills. Ability to work collaboratively and effectively in a cross functional and culturally diverse teams. Ability to work independently/responsively and with tight deadlines and under pressure. Quality mind-set and strong analytical skills, Strong attention to detail , Proactive and resilient to changes . Interact with colleagues, stakeholders, project members, management in a proactive and professional manner.

Novo Nordisk Global Business Services (GBS), India Department- Centralised Monitoring Unit (CMU)- Bangalore Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers), technical programmers (Functional programmers, statistical monitors) and Medical Illustrators. Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials. Medical Illustrators are responsible for developing engaging visual content for our clinical meetings. The Position As Central Monitor, an ideal candidate will be responsible for providing inputs in defining standard and trial specific key risk indicators and performing ongoing monitoring of operational risks. Ensure both standard and trial specific Key Risk Indicators (KRIs) impacting patient safety and data quality and regulatory compliance are appropriately defined as per protocol, monitoring strategy etc prior to start of centralised operational monitoring review. Responsible to Perform ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives. Provide inputs to applications, databases and systems used to monitor operational data. Responsible for communication and findings of operational review to relevant stakeholders to enable decision making. Act as primary contact for relevant stakeholders and participate in project meetings for assigned centralized monitoring studies . Prior experience with RBQM (Risk-Based Quality Management) and field monitoring as a CRA is desirable. Familiarity with analytical tools is preferred, as well as experience using SAS, Python, R, and SQL. Contribute to discussions around share learnings and practices with wider CMU department colleagues and with other relevant stakeholders Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements. Qualifications Minimum of bachelors degree in life science/scientific or health care discipline. Above 3 years of relevant clinical research experience with good knowledge of drug development process and risk-based quality management principles. Prior CRA/Field Monitoring and analytical tool experience is desirable Skill in aggregate data review and interpretation using visualization/analysis softwares Solid understanding of clinical trial design, trial execution and operations. Ability to successfully manage multiple projects and priorities. Good Communication & Presentation skills. Ability to work collaboratively and effectively in a cross functional and culturally diverse teams. Ability to work independently/responsively and with tight deadlines and under pressure. Quality mind-set and strong analytical skills, Strong attention to detail , Proactive and resilient to changes . Interact with colleagues, stakeholders, project members, management in a proactive and professional manner.

Medical Writer II (QC of Regulatory Docs) Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong. Job Responsibilities Job Description Experience in QC of regulatory MW documents (protocols including amendments, CSRs, IBs and updates, etc). Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads document reviews, reviews documents as needed, and resolves comments from client. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content,and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts and builds good working relations with clients, department head, and peers, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve document issues, escalating as appropriate. Mentors less experienced medical writers on projects, as necessary. Maintains a strong working knowledge of drug development process, regulatory guidelines,industry standards, and best practices. Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Performs other work-related duties as assigned. What were looking for: Bachelor s degree in a relevant discipline with relevant writing experience; graduate degree preferred. At least 2 years of relevant experience in science, technical, or medical writing. Experience working in the biopharmaceutical, device, or contract research organization industry preferred. Familiar with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred. Experience writing relevant document types preferred. Extensive knowledge of English grammar and ability to communicate clearly; familiar with AMA Manual of Style.

Medical Writer II (Narrative Writing) Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong. Job Responsibilities Main experience in CSR safety narratives writing (authoring, addressing review comments, collaborating with teams) Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads document reviews, reviews documents as needed, and resolves comments from client. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content,and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts and builds good working relations with clients, department head, and peers, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve document issues, escalating as appropriate. Mentors less experienced medical writers on projects, as necessary. Maintains a strong working knowledge of drug development process, regulatory guidelines,industry standards, and best practices. Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Performs other work-related duties as assigned. What were looking for: Bachelor s degree in a relevant discipline with relevant writing experience; graduate degree preferred. At least 2 years of relevant experience in science, technical, or medical writing. Experience working in the biopharmaceutical, device, or contract research organization industry preferred. Familiar with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred. Experience writing relevant document types preferred. Extensive knowledge of English grammar and ability to communicate clearly; familiar with AMA Manual of Style.

We are looking for a skilled Senior Coder with 2-4 years of experience to join our team in Chennai. The ideal candidate will have a strong background in coding and analytics, with excellent problem-solving skills. Roles and Responsibility Analyze medical records and assign accurate codes for diagnoses and procedures. Review and validate coding quality for accuracy and compliance. Develop and implement coding standards and guidelines. Collaborate with healthcare professionals to clarify coding discrepancies. Conduct audits to ensure coding compliance with regulations. Provide training and support to junior coders on coding best practices. Job Strong knowledge of coding principles and regulations. Excellent analytical and problem-solving skills. Ability to work accurately and efficiently in a fast-paced environment. Effective communication and collaboration skills. Strong attention to detail and organizational skills. Ability to maintain confidentiality and handle sensitive information. Experience working with CRM/IT Enabled Services/BPO industry. Company nameOmega Healthcare Management Services Pvt. Ltd. Reference number1376745.