543 Medical Writing Jobs - Page 15

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

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

Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Periodic Report QC Reviewer What you will do 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. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying medical or technical information into clear, structured documents and engaging content. Good Knowledge of Medical terminology. Required Candidate profile Preparation of protocol for Clinical trials Preparation writing CSR (Clinical Study Report) BDS and MBBS With medical writing for clinical trials Knowledge are Applicable

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Role & responsibilities: 1. Authoring and Quality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH, ,National registries (DIMDI)) CTT Data base experience ( Disclose, Prime, PRS, EudraCT) Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process

Role & responsibilities: 1. Authoring and Quality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process Preferred candidate profile: Experience in redactions/anonymization of clinical documents as part of preparation for different regulations. Well versed with Health Canada /EMA policy.

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

We are seeking a qualified and experienced Professor of Respiratory Medicine to join our esteemed medical faculty. The ideal candidate will have significant clinical experience, a passion for teaching, and a commitment to advancing research in the field of respiratory health. Responsibilities Teach and mentor undergraduate and postgraduate students in respiratory medicine. Conduct research in the field of respiratory medicine and publish findings in reputable journals. Provide clinical supervision and training to residents and fellows in respiratory medicine. Participate in departmental meetings and contribute to curriculum development. Engage in community outreach programs to promote respiratory health awareness. Skills and Qualifications MD or DNB in Respiratory Medicine from a recognized institution. 8-12 years of clinical experience in respiratory medicine. Strong knowledge of current trends and advancements in respiratory medicine. Excellent communication and interpersonal skills for effective teaching and patient interaction. Proven track record of research publications in peer-reviewed journals. Ability to work collaboratively within a multidisciplinary team.

We are seeking a dedicated and knowledgeable Assistant Professor of Pharmacology to join our esteemed institution. The ideal candidate will have a strong background in pharmacological sciences and a passion for teaching and research. This position offers an excellent opportunity to contribute to the academic and professional development of students in the field of pharmacology. Responsibilities Teach pharmacology courses to undergraduate and postgraduate students. Conduct research in the field of pharmacology and publish findings in peer-reviewed journals. Supervise and mentor students in their research projects and clinical rotations. Participate in departmental meetings and contribute to curriculum development. Engage in community outreach and educational programs related to pharmacology. Skills and Qualifications MD or DNB in Pharmacology or related field from a recognized institution. Strong understanding of pharmacological principles and their application in clinical settings. Excellent communication and presentation skills. Ability to work collaboratively in a team-oriented environment. Research experience in pharmacology with a track record of publications is preferred. Familiarity with educational technology and online teaching platforms.

Authoring/editing of clinical documents Review of the clinical/safety documents Assist senior writers Keep abreast of project status Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Required Candidate profile 3+ years’ of authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents including protocol, informed consent document, clinical study report, etc.