279 Medical Writing Jobs - Page 4

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Roles & Responsibilities:- Experience in medical writing domain across different therapeutic areas in clinical documents including protocol, informed consent document, clinical study report, investigator's brochure, clinical summary of pharmacology, clinical overview (efficacy and safety); and/or safety documents like Development safety update report (DSUR), Periodic benefit risk evaluation report (PBRER), Risk Management Plans (RMPs), addendum to clinical overviews (aCOs) Experience in preparation of clinical/safety documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies preferred Experience in writing and review of scientific/clinical documents preferred Knowledge of clinical research domain, ICH GCP principles and regulatory requirements preferred Effective coordination and presentation skills - Good organization and time management skills Exceptional interpersonal, verbal and written communication skills

Roles and Responsibilities The manager-medical affairs would be required to do the following activities. Take medical trainings on the therapeutic aspects of the marketed products for the sales people. Help brand management team in creating medical communications for the doctors. Answer medical queries of the doctors related to marketed products. Preparing and delivering medical presentations in doctor CMEs. Involving in the ongoing clinical studies. The person is expected to do outstation travelling for 3-4 days in a month for company related meetings. The person should have good communication skills and should be well versed with MS Office. The person qualification should be MBBS. Postgraduation in medicinal fields (MD) would be an added advantage. Desired Candidate Profile Qualification: MBBS Experience: 1 to 6 Years

Immediate Job Openings for our Pharma Clients Job Profile Quality Assurance, Quality Control , CRA , R & D , Pharmacist , Medical Claims , Medical Record summarization , Medical Billing , Medical Writer , BDM , CDM , RA Production ,

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation 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 Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Junior Drug Safety AssociateJunior Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Physiotheraphy

Narayana Nethralaya is looking for Consultant Physician to join our dynamic team and embark on a rewarding career journey Consultant PhysicianDiagnose medical conditions Provide patient care Monitor treatment plans Collaborate with healthcare teams

YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 3+ years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 3+ years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

Job Summary: This role will responsible for preparation of clinical high-quality protocol, investigator brochures, regulatory documents, data review, clinical study report, publications, and related clinical documents. Manuscript writing, poster/abstract preparation for conferences, co-ordinate with vendors for out-sourced activities and assist for procurement of scales. YOUR TASKS AND RESPONSIBILITIES: Systems and Processes: Ensure to follow all clinical and regulatory guidelines, processes and systems for medical science activities and ensure compliance to internal medical writing SOPs for Clinical trial To follow the designed process to write, review protocol for new trials and work closely with operation team to ensure high quality operationally feasible protocol for clinical trial To co-ordinate with a process for review of all study synopsis from clinical, regulatory and operational perspective Prepare and review SOPs specific for medical writing for clinical trial Work closely with medical monitors for review of study documents (such as statistical analysis plan, data monitoring plan, coding plan, CRF) and data review activities Identify, recommend and lead process improvement initiatives Create and evaluate metrics to assess performance and implement plans for course correction Well versed with systems (MedDRA and WHO-DD) for data coding including coding of adverse events and drugs Good knowledge of different randomization procedures and different blinding techniques to be used in clinical trials Identify, recommend and lead process improvement initiatives Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Responsible for clinical trial medical science related activities like preparation of protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement Conduct relevant literature search for required for protocol, CSR, and manuscript writing Responsible for writing clinical journal manuscripts, clinical journal abstracts, and study article for publication Responsible for preparation of protocol and clinical study reports presentation in subject s expert committee (SEC) regulatory meeting Responsible for collaboration with vendors for manuscript writing, abstract/poster preparation, procurement of clinical scales/PROs (Patient reported Outcomes) Responsible for coordination with data management team to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs) Responsible for coordinating with biostatistician to engage early with the study team for sample size certificate, review of statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents in co-ordination with medical monitor Responsible for registering on clinical trials registries (e. g. CTRI) Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables Responsible for mentoring and leads less experienced medical writers on complex projects, as necessary WHO YOU ARE: B. Pharma/M. Sc/M. Pharma/PhD/BAMS/BHMS/life sciences educational background 0-1 years of relevant medical writing experience Excellent medical writing skills Well versed with different guidelines such as IMRAD, CONSORT and different publication guidelines Well versed with different guidelines such as IMRaD, CONSORT and relevent publication guidelines Well versed with current GCP/GDP regulations Thorough knowledge of GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials and other regulatory guidelines like FDA Experience of working in matrix business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Strong medical knowledge of different therapeutic area Sound functional knowledge of clinical research and medical writing activities Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Good writing and communication skills Sense of urgency desire to excel Proficiency with Excel or software statistical tools. Self-awareness and adaptability to work in a matrix environment Result oriented and performance driven Excellent interpersonal communication skills to effectively interact with a broad range of audience Job location: Sun House, Goregaon East, Mumbai

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan Responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart Jointly responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

Review medical records, including clinical notes, reports, and other relevant documents to ensure accuracy and completeness. Conduct thorough summaries of patient medical history, diagnoses, treatments, and outcomes using standardized templates. Collaborate with healthcare providers to clarify discrepancies or missing information in the record. Maintain confidentiality and adhere to HIPAA guidelines when handling sensitive patient data. Ensure timely completion of tasks within designated timeframes. Desired Candidate Profile 1 year of experience in medical summarization or related field (e.g., transcription). Strong understanding of medical terminology, anatomy, physiology, and pharmacology. Excellent English writing skills for clear documentation of complex medical information. Ability to work independently with minimal supervision while maintaining attention to detail. Timings Fixed shift Morning Shift ( 8 AM to 5 PM ) Fixed weekend off Work from office If interested, please share your resume at siddharth.sangare@aminfoweb.co.in Call/WhatsApp: HR Siddharth - 9518398608 Know our organization - https://www.aminfoweb.com/ Know our workspace! - https://www.youtube.com/watch?v=T1UKFelepCk&list=PL_o6eSpS5htOsmrvlOh27wRiU4soGrOU&index=6 Our Annual RNR'2022 - https://www.youtube.com/watch?v=9JMRQBhk3i8&t=14s Exploring the myths surrounding outsourced healthcare management - https://www.youtube.com/watch?v=fwf3jFa2T-A

KASHI INSTITUTE OF TECHNOLOGY is looking for Senior Research Assistant (SRA) / Research Assistant ( RA) to join our dynamic team and embark on a rewarding career journey Conduct Research: Design and execute experiments or research projects under the guidance of senior researchers or project leaders. Collect, analyze, and interpret data using various research methodologies and tools. Literature Review: Review relevant literature to understand the current state of knowledge in the research area. Stay updated on advancements in the field and incorporate relevant findings into ongoing research. Data Collection and Analysis: Utilize appropriate techniques to gather data, whether through experiments, surveys, interviews, or other methods. Analyze and interpret data using statistical methods or other relevant analytical approaches. Report Writing: Prepare detailed reports summarizing research findings, methodologies, and conclusions. Contribute to the writing of research papers, articles, and presentations for conferences or publications. Collaboration: Work closely with team members, senior researchers, and other stakeholders to achieve research goals. Participate in research meetings, seminars, and conferences. Equipment and Lab Maintenance: Maintain and operate laboratory equipment as needed. Ensure proper documentation and organization of research materials. Compliance and Ethics: Adhere to ethical guidelines and standards in research activities. Ensure compliance with relevant regulations and protocols.

Strategic/Policy: Medical Advisor With support from the mentor or Line manager, provide tactical and strategic inputs, and business/technical expertise , to Product Management towards ethical promotion of assigned products, in the operational areas listed Operational Commercialization/Promotion of Allocated Portfolio (New/Key Detail/In-line Products) Under supervision from the Line manager or the mentor, provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines Under supervision from the Line manager or mentor, initiate and/or review and/or approve promotional, training, and Continuing Medical Education (CME) material in compliance with relevant SOPs/regulations/industry codes/working practices In consultation with the Line manager or mentor, participate /facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, etc. Clinical Research In consultation with concerned stakeholder/vendor/interface, develop/write and/or review and/or approve protocol synopsis/final protocols/supporting documents per need (e. g. , investigators brochure (IB), informed consent form (ICF), patient information sheets, etc ) for , Phase IV, PMS, Observational studies / surveys, Pharmacoeconomic / Outcomes Research studies, and other clinical projects / programs. In consultation with concerned stakeholder/vendor/interface, review and approve additional supporting documents/databases including ICF/CRF/SAP, etc Assist in planning, organizing and preparing Investigational New Drug Applications (NDAs) Review/interpret data generated; write final reports for locally sponsored studies as required Develop and execute Publication Plan; review/approve/write manuscripts for publication of locally sponsored studies Develop and execute Information Dissemination Plan/Program Medical Information Provide useful, timely , accurate , and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies Sales Force Training Provide medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives Provide pre-launch and launch training to sales staff for new products New Product Planning/Development For global products, assist NPP team with preparing business case, and pre-commercialization programs/initiatives/activities to prepare internal and external stakeholders for commercialization. These include assistance with market research, stakeholder mapping, and early access programs Support New Product Planning, Marketing, and Business Development colleagues with medical evaluation and recommendations on commercial opportunities with new products (e. g. , licensing, acquiring , co-promotion, etc. ) Support organization efforts at developing local formulations/line extensions through literature search/recommendations. Function as custodian for coordinating internal and regional approvals through the RFD (Request For Development) process Regulatory Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/ indication . Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc. ) Write, revise, and review labeling documents for pipeline/local products per relevant SOPs Provide medical support towards processing of spontaneous/ solicited AE reports, per relevant SOPs and/or working practices Values and Behaviors: Consistently adhere to/ demonstrate all Pfizer Values/Leader Behaviors, with special focus on excellence, equity, courage and joy. Work in harmony with internal and external stakeholders. Qualification & Experience Basic medical degree (MBBS/BDS/MD/MS/MDS) or doctorate degree ( Ph. D. ) from recognized institution or university with at least 2 years of experience in pharmaceutical industry Graduates in Medicine with at least 3 years of clinical practice or clinical research or other relevant experience Special Skills & Knowledge Basic knowledge of pharmaceutical industry, drug discovery, research & development, commercialization, promotion, and applicable policies, procedures, regulations, and guidelines Knowledge of pharmaceutical medicine including clinical pharmacology, medical and paramedical sciences, medicine and medical statistics and relevant Therapeutic Area/Products Expertise in clinical trial design and methodology , and understanding of interfaces, and conduct Communication skills, both written and verbal (including medical writing and presentation skills) Analytical skills and reasoning, and sound medical judgment/decision making Interpersonal skills, internal & external networking and the ability to impact and influence Work Location Assignment: On Premise Medical #LI-PFE

YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 1-3 years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

Key Responsibilities: Review and assess medical documents, including clinical trial data, safety reports, and regulatory submissions, for accuracy, consistency, and compliance with industry standards. Assist in the preparation of regulatory documents, such as clinical study reports, informed consent forms, and patient safety reports. Ensure that all content aligns with medical and scientific guidelines, including Good Clinical Practice (GCP) and regulatory requirements. Collaborate with senior medical reviewers and other cross-functional teams (e.g., clinical research, pharmacovigilance, regulatory affairs) to ensure the timely and accurate delivery of medical documents. Review medical literature and stay updated on the latest clinical and scientific research relevant to assigned projects. Identify and flag potential issues or discrepancies in clinical trial data or reports. Assist in the preparation of training materials or presentations related to medical review processes. Support senior medical reviewers in maintaining high standards of medical and scientific integrity.

Job description Bangalore, India Job category Reg Affairs & Safety Pharmacovigilance Department Global Safety - Global Business Services (GS-GBS). 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. The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required. You will be required to establish, operate and chair the NN cross-functional safety committee throughout the lifecycle of the actual product present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations. You will be responsible for all areas related to patient safety in clinical trials. You are entrusted to fulfil the following responsibilities Act as Ownerof the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer. As author you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates. Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator s Brochure (IB), integrated safety summaries, abstracts and planned publications. You will provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required. Provide answers to enquiries from HAs and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs). Qualifications Masters in Medicine/MD post MBBS graduate is Preferred. Relevant Experience in Signal Management, Aggregate Management, ICSR. Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint). Fluent in written and spoken English. Analytical mind-set. Professional authority. Quality mind-set, well-organised and strive for excellence. Pro-active planner to meet agreed deliverables. Strong communicator (verbally and in writing). Curious and constantly looking for improvement opportunities. Team player with high degree of flexibility and service mindedness. Cross-cultural awareness. Ability and willingness to quickly adjust to changes in a continuously developing environment.

Job Requirements We are looking for an experienced Medical Content Writer to join our team at Torrent Diagnostics. In this role, you will be responsible for creating and editing content for our website, blog, and other digital platforms. You will be expected to research and write content that is accurate, engaging, and SEO-friendly. You should have a good understanding of scientific concepts and be able to explain them in a simple and concise manner. Additionally, you should be able to work independently and be able to meet tight deadlines. Responsibilities: Research and write content for our website, blog, and other digital platforms. Ensure accuracy and consistency of content. Ensure content is SEO-friendly and follows the E-A-T guidelines. Edit and proofread content for accuracy and clarity. Monitor and analyze content performance. Stay up-to-date with the latest trends in scientific content writing. Requirements: Bachelors degree in a related field. 10+ years of experience in scientific content writing. Excellent writing, editing, and proofreading skills. Knowledge of SEO and E-A-T guidelines. Ability to work independently and meet tight deadlines. Excellent research and analytical skills.

Summarize the case history of patients for deep analysis of medical records required Knowledge of disease conditions, treatments, tests, and medications Ensuring accurate and documentation of medical history, suspect drugs and concomitant medications Required Candidate profile Qualifications: M. Pharma / BPT/ MPT / BDS / Pharma D Knowledge of US Culture/ US Healthcare System Knowledge of disease conditions, treatments, tests, and medications info.aspiringmantra@gmail.com