178 Medical Affairs Jobs - Page 3

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment. As a Deputy Marketing Manager / Product Manager you will support on strategy formulation, messaging of product/category and lead implementation of strategic objectives, by collaborating with Commercial Sales team and Business / Franchise / International Marketing. You will also work with KOL s in the region and establish Grifols as a partner in advancing science and therapy awareness. Finally you will track market share and penetration objectives. What your main responsibilities will be You will have the opportunity to: Participate in formulating Marketing Strategies and ensure implementation (coordinate with International / Global Marketing & ensure alignment of India strategy to Global Biopharma strategy, coordinate with regional Sales team, and track implementation of strategy (PSPs) and work on the conceptualization of marketing ideas and themes to run campaigns and activities aligned to the overall strategy. Prepare Annual Market Reports for the affiliate. Analyse and make proposals for new product launch. Develop and implement a business-wide go-to-market plan (GTM), with periodic reviews to measure implementation. Design and implement activities along with Medical Affairs for SME advocacy. Coordinate internally as per the Policy with Global Compliance for approvals as required for any Marketing Initiative, campaigns, events, etc. Build & maintain professional & ethical relationships with key accounts, medical fraternity, opinion leaders/KOL and thereby ensuring high customer satisfaction. Monitor & report market conditions and competitor activities on an ongoing basis; and propose counter-strategies to pre-empt and counter these conditions/activities. Maintain MIS for and reporting on key global Franchise / Marketing projects. Provide inputs on market trends, shifts related to product usage. Monitor marketing spend, maintain dashboards and use Salesforce for analytics. Train Regional Sales team and distributors in Product and Therapy. Who you are The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. You have experience in some of the following segments: Hepatology, Intensive Care, Hematology and Genetic blood disorders. You have at least 5 years of experience in an established Lifesciences / Pharmaceutical / Healthcare / Medical devices Company. You hold a MBBS or Bachelor in Pharmacy or Masters in Pharmacy. MBA in Marketing will be preferable. You are an effective communicator with excellent interpersonal & relationship management skills required for Stakeholder management (internal/external). You have availability to travel. What we offer It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don t hesitate to apply! We look forward to receiving your application! We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our recruitment process, please do not hesitate to inform us when applying. We are here to help. Grifols is an equal opportunity employer. Benefits package. Contract of Employment: Permanent position. Location: APAC : India : Gurgaon:Mumbai Learn more about Grifols

. Preparation of scientific medico-marketing initiatives. . Supporting clinical research team with medical inputs . Clinical Studies/ Publications . Training & Development of sales and marketing team . Scientific Literature search Required Candidate profile MBBS + MD (Pharmacology) with 3+ years of experience. Well equipped with Communication & Interpersonal skills, making visual aids, news letters, advertisement sheet and solving scientific queries.

YOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures. Systems and Processes: Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations. Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department. To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed. To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness. Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements. Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols. Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team. Assess and identify the training requirement of study team and ensure completion of training. Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability. Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed. Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement. Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7. Ensure periodic review of Vendors and renewals as per applicable policies & procedures. Identify and recommend process improvement initiatives where required. Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets. Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices. Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team. Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement. Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites. Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents. Review and communication of QC findings to respective department in stipulated timelines. Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required. Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis. Ensure training of SOPs, on job training and reviewing training files on regular basis. QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans. Ensure record maintenance for all activities for traceability in line with regulatory requirement. WHO YOU ARE: > 5 years experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department. Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills. Must have experience in handling audits & inspections of DCGI, US FDA. Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials. 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. Quality oriented mindset and skill set. Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA). In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research. Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements. Have strong analytical and problem-solving skills and the ability to present solutions. Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization. Eye for details, Sense of urgency & desire to excel. Proficiency with Excel or other quality management systems/ tools. 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: 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

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: 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

Life-changing careers - Check out this open position at Novo Nordisk Job description Job description Are you an experienced medical professional and passionate about Clinical MedicalDoes being part of a growing, yet dynamic environment excite youIf yes, then you may be the one we are looking for as Clinical Medical Manager for Novo Nordisk India. Apply now! As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research center s within the relevant therapy areas. Collect early scientific insights and guidance by discussing relevant early development data with external medical and scientific experts. Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations. Provide timely medical guidance and internal training to clinical staff. Engage in extensive scientific communication both internally and externally, requiring strong presentation skills. Performing ad hoc visits, Supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials and engaging key investigators to communicate trial results. Qualifications To be successful in this role, you should have the following qualifications: MD in any discipline with a strong clinical research/medical affairs background. 5 years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs, or pharmaceutical industry. Expertise in therapeutic areas of relevance (CVD, CKD, NASH), preferably with authorship in peer-reviewed journals. Understanding of pharmaceutical drug development. Open to domestic and international travel in connection with site visits, congresses, and company events. Experience as a clinical trial investigator or sub-investigator. Understanding the specificities and nuances of the local healthcare infrastructure. The CMR (Clinical, Medical, Regulatory & Pharmacovigilance) team based in Bangalore. Our team is dedicated to driving clinical trials and providing medical/scientific expertise in New Therapy Areas. We work closely with KOLs, independent professional associations, and patient advocacy associations to ensure the successful execution of clinical trials. The atmosphere is collaborative and dynamic, with a strong focus on scientific excellence and patient outcomes. Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we re working toward something bigger than ourselves, and it s a collective effort. Join us! Together, we go further. Together, we re life changing. To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Managers before applying. It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we re life changing.

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

Oversee clinical quality, patient safety, and medical protocols. Lead and mentor medical staff. Ensure full compliance with healthcare regulations Drive quality improvement and clinical outcomes. Strategically collaborate with executive leadership. Required Candidate profile MBBS/MD with valid medical license. 8-15+ years of extensive clinical practice. 5+ yrs of proven leadership/management experience in healthcare. Excellent communication MBA/MHA is a significant plus.

Key Responsibilities: Scientific & Medical Expertise Serve as a subject matter expert in neuroscience, providing high-quality scientific and medical support to internal and external stakeholders. Stay updated on the latest scientific advancements, treatment guidelines, and competitive landscape in neuroscience. Provide scientific training to internal teams, including commercial and market access teams. Stakeholder Engagement & Medical Communication Develop and maintain strong relationships with Key Opinion Leaders (KOLs), healthcare professionals (HCPs), and academic institutions. Lead scientific discussions and advisory boards to gather insights and address unmet medical needs. Deliver presentations at medical and scientific meetings, congresses, and symposia. Medical Strategy & Evidence Generation Contribute to the development and execution of the Medical Affairs Plan for neuroscience. Collaborate with cross-functional teams to provide medical input into brand strategies and regulatory submissions. Compliance & Ethical Standards Ensure all medical activities align with company policies, industry regulations, and ethical guidelines. Review promotional and non-promotional materials for scientific accuracy and compliance with regulatory standards. Key Requirements: Education: MD, BDS, PhD, or PharmD preferred (MSc or MBBS with relevant experience may be considered). Experience: Minimum 2 years of experience in Medical Affairs or a related role in the pharmaceutical industry, preferably in neuroscience. Scientific Knowledge: Strong understanding of neuroscience disease areas, treatment landscapes, and clinical data interpretation. Stakeholder Engagement: Experience in engaging with KOLs, HCPs, and scientific societies. Communication Skills: Excellent written and verbal communication skills, with the ability to translate complex scientific data into meaningful insights. Regulatory & Compliance Knowledge: Familiarity with local and global regulatory frameworks (e.g., ICH-GCP, FDA, EMA, DCGI guidelines).

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Medical Affairs Group Job Sub Function: Multi-Family Medical Affairs Job Category: People Leader All Job Posting Locations: Mumbai, India Job Description: Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity. Innovative Medicine, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, we bring innovative products, services and solutions to people throughout the world. Innovative Medicine recognizes the impact of serious conditions on people s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas. Position overview: The Country Medical Affairs Head is responsible for leading and managing the medical affairs function, covering Johnson & Johnson Innovative Medicine business, within the countries. The position is a member of the country management team and plays a major role in providing medical and scientific inputs and comments on company business plans, business issues, crisis management and other quality and compliance issues arising. The position is responsible for developing and implementing a robust medical strategy and plan that (i) at the disease level, aims to improve standard of care (by enhancing awareness for the disease and unmet medical needs amongst treating physicians, by advocating for quality medical practices amongst treating physicians, policymakers and payers, and by effectively contributing to closing of practice gaps), and (ii) at the asset level, aims to enable full understanding of a brand s differentiated value at launch, and ensuring its safe and appropriate use (by means of data generation, data understanding, data packaging, data dissemination, and by implementing a robust patient / consumer safety vigilance plan). The position is responsible for ensuring that all medical activities are compliant with country legislation, company policies and procedures, are consistent with the JNJ Credo, and comply with Health Care Compliance rules. Key Responsibilities : Integrate Medical Insights into Medical Planning and Operating Company Strategic Planning Design, develop and implement Medical Country Strategic Plans in alignment with Company Objectives, with reference to global and regional strategic direction as well as the intelligence collected from relevant external stakeholders. Develop and maintain a scientific network with key thought leaders, advisors and the local scientific community to obtain key insights and to develop strategic partnerships Participate in the overall country strategic and annual business planning and resource allocation process. Be responsible for monitoring medical spending and project costs. Lead the Country Medical Operation Lead and hold accountability for the execution of medical plans to support disease and product/brand objectives. Accountable for the internal review and governance and of Company and Investigator Initiated Studies Accountable for medical approval of all public presentation, media, and core brand related promotional materials to ensure scientific validity and compliance with relevant internal and external standards Be Responsible for People Development and Management Responsible for the hiring of appropriately qualified medical staff, and the development, implementation, and monitoring of their personal development plans to continuously build capabilities, TA s and brands. Build a team culture of high performing, engaged medical experts. Work with HR to implement and drive team performance metrics Coordinate and strengthen medical interactions with other functional teams Partner with Business Leaders in developing and deploying Practical and Innovative Evidence-based Solutions to Facilitate Stakeholder Adoption of innovative medicines Lead and participate actively in collecting accurate information on customer needs Collaborate with appropriate business leaders in developing relevant customer-centric strategies and solutions Identify and develop relevant capabilities that support and help sustain strategic initiatives, (e.g., training, curriculum development, learning development programs) Develop relevant metrics that facilitate troubleshooting and optimization of deployment of strategic initiatives Collaborate with other Medical Directors and / or Medical Affairs Directors to foster exchange of best practices Provide Practical, Evidence-based Expert Opinion on medical and scientific matters Provide scientific and medical insights into relevant Leadership Team meetings Provide expert medical opinion into regulatory submission strategy and execution Provide expert medical input into company crisis management Ensure External and Internal Compliance Drive compliance through understanding, implementation, and adherence to HCBI, global/regional/local SOPs, GSQA, local regulatory policy and industry codes of practice Oversee the Operation of Patient Safety Collaborate with the LSO team to ensure timely safety reporting throughout the life cycle of the products according to company requirements and local regulations Coordinate with Regulatory Affairs Operations, Compliance and Legal Work with Regulatory Affairs, Compliance and Legal personnel to monitor external regulatory environment, identify risks, and communicate potential issues to management Work with Regulatory Affairs personnel to formulate the regulatory strategy Qualifications - External Scientific Medical Degree, MBBS, MD or equivalence required At least 8 years experience in Medical Affairs/medical function with people management experience is required Proven track record of ability to work within a matrixed organization Deep understanding of local regulatory policy and industry s code of practice related to drug registration, pharmaceutical promotion, and clinical study Expertise in ICH Good Clinical Practice Track record of leadership across the medico-marketing interface Successful track record of applying scientific knowledge to commercial activity Business qualification (e.g., MBA) desirable Experience in managing professionals in the pharmaceutical or related industries preferred Are you ready to impact the world? Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage Should have good communication Skills

The Business Insights & Analytics group already provides broad and deep analytical expertise and operational support to a range of functions and has built similar capability for Medical Affairs. This role, the BI&A Medical Affairs Analyst will work on a range of RWD sources and apply analytical/statistical methodologies, while always striving for process improvement, innovation in close collaboration with the other analytics teams. Key Roles and Responsibilities Project Execution : primary owner of the following tasks Build deep expertise on necessary data sets and supports data enabled decision making using a range of RWD sources (claims databases, EMR/EHR/Lab etc) and internal Lilly data (Veeva, Customer 360 etc) Ensure high stakeholder satisfaction through consistent delivery of high quality, timely and insightful outputs throughout analytics value chain on various objectives related to the patient journey, unmet needs, omnichannel engagement, segmentation, targeting, and data support through data mining and warehousing Develop into a trusted advisor by actively participating in various phases of the project including kick-off, methodology development, execution, insight generation and data visualization and results presentation to various stakeholders Participating in meetings with stakeholders and communicating the final outputs and recommendations Project management : support the team leader as needed on the below tasks Creation and maintenance of standard operating procedures (SOPs), quality checklists that will enable excellent quality outputs Shared learning forums to identify challenges and establish best practices Expansion of analytical capability of the team by taking on more complex projects and delivering value Process improvements and implementation of analytical best practices Education/Experience Requirements Undergrad in quantitative field (Engg, Math/Stats, quant economics/econometrics etc) 3-6 years of analytics experience with demonstrated ability to think strategically in an ambiguous environment in analytics, especially in pharma/other lifesciences Prior experience of working on a range of pharma/healthcare data sets highly preferred, especially a variety of RWD, including but not limited to syndicated insurance claims databases (IQVIA, Symphony, etc), EMR/EHR/Lab data (IBM MarketScan, Prognos etc), National/international patient registries Prior experience in therapy areas including Cardio Metabolic Health, Immunology, Oncology, Neuroscience or related areas is highly preferred Coursework/qualifications in analytics, statistics, RWE generation, quantitative health economics, patient outcomes will be a plus Technical Skills Strong experience in SQL; fluency in one of R/Python Hands-on experience with at least 1 data viz tool like Tableau, PowerBI etc Advanced MS-office skills (MS-Excel and MS-PowerPoint) Soft Skills Strong work ethic and personal motivation Good presentation skills Interpersonal and communication skills with ability to work across time zones Ability to operate effectively in an international matrix environment Strong stakeholder management skills Strong team player who is dynamic and result oriented

Business: Piramal Critical Care Department: Sales Location: Kurla Travel: Medium Job Overview This role involves leading Piramal Critical Care s commercial operations in ASEAN markets by driving revenue growth, managing strategic business partnerships, and ensuring excellence in execution. The incumbent will be responsible for market expansion, business profitability, local regulatory coordination, and cross-functional collaboration. The role demands a high level of ownership, leadership, and strategic agility to accelerate market share and operational success. Key Stakeholders: Internal Supply Chain, Regulatory Affairs, Finance, Medical Affairs, Marketing, Quality, Pharmacovigilance, Compliance, Legal Key Stakeholders: External Business Partners/Distributors, Key Opinion Leaders (KOLs), Tender Authorities, Consultants, Regulatory Bodies, Customers Reporting Structure Reporting to: Associate General Manager - ANZ & East Asia and ASEAN Essential Qualification Graduate in Pharmacy / Medicine with a Management Degree in Marketing/Hospital/Healthcare Experience 5-7 years of experience in pharmaceutical / healthcare management with proven success in managing commercial operations. Exposure of International markets will be an added advantage. Key Responsibilities: Develop, manage, and strengthen regional partnerships to meet business objectives Achieve annual sales targets while optimizing operating expenses Create and execute country-specific business plans with partners, influence demand generation, pricing, tenders, and conversions Conduct competitor and market analysis for proactive decisions, Monitor secondary sales, stock levels, and in-market performance Implement solutions to address market challenges effectively Engage with KOLs and external stakeholders to gather insights Identify new growth opportunities and enhance market share Drive successful Go-To-Market strategies for new launches Champion customer and patient-centric initiatives and ensure compliance with EHS, quality, and sustainability policies Use internal tools to track forecasts, complaints, and KPIs, coordinate with cross-functional teams to fulfill customer needs Align training and marketing initiatives with business partners Manage receivables and financial coordination Foster clear communication across internal and external teams Assess training needs and execute plans for customers Competencies: Strategic Thinking & Commercial Acumen Stakeholder Management & Influence Strong Analytical & Decision-Making Skills Execution Excellence & Operational Agility Leadership & Team Development Collaboration & Cross-functional Integration Market Understanding & Customer Focus Compliance & Quality Orientation

- Promote services with doctors/departments Plan campaigns, health programs Manage social media, website content Coordinate with creative agencies Monitor competitors' trends Analyze feedback, campaign data Support branding communication. Provident fund Travel allowance Job/soft skill training Transition assistance program

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

The PV Scientist is primarily responsible for the conduct of benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation, review and submission of aggregate reports; signal detection; support of benefit-risk evaluation efforts; generation of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification and tracking of risk minimization measures; handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities. Other activities relevant to the medical assessment responsibilities can also include: Query management; coordination with internal and external stakeholders for assigned medical assessment activities, and quality review of deliverables. All of the above are conducted in accordance with regulatory requirements and internal DRL standards. Main Responsibilities: Signal management: Conduct signal management activities for assigned products, performing initial review of signal alerts, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule. This may include interaction with the LifeSphere Signal Management System and/or review of outputs generated from the system. Aggregate Reports and RMPs: Contribute to the scheduling of aggregate reports, RMPs and other safety related documents to ensure all required reports are documented on the report calendar. Maintain and harmonize global trackers for all aggregate reports across the regions Preparation of aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs, ACOs. Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor and by internal resources. Ensure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements Prepare RMPs and contribute to REMS activities as required Contribute to the implementation and tracking of additional risk minimization measures in collaboration with PV physicians, local affiliates and third party partners Prepare Health Hazard Evaluations and other ad hoc safety reports as requested Conduct benefit-risk evaluations under the supervision of PV physicians Clinical & Regulatory Activities: Provide safety input to other cross-functional documents, including clinical study protocols, study CRF, statistical analysis plan (SAP), coding review reconciliation, final study reports, dossier documents and other documents required to support filing activities. Participation in product/project team meetings. Provide safety input, advice and support to commercial, marketing and Medical Affairs activities as required Labeling document review: under the supervision of PV physicians, provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV –related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure Provide data for internal compliance meetings, monthly report and for inclusion in the PSMF as required Raise deviations to PV processes where identified Participate in development of CAPA and take ownership of CAPA completion where assigned Participate in regular, scheduled meetings with PV team/service provider/third parties as required Initiate or support the development and revision of PV Medical Assessment SOPs and work instructions. Also participate in the review of cross-functional SOPs which include reference to PV Medical Assessment Activities. Support PV training for new members of PV team and non-PV personnel, particularly product-specific, scientific and medical training Perform other ad hoc, PV related activities as requested by head medical assessment Relationship Management Working within PV team and cross-functionally Interactions with vendors/service providers for PV activities Process Improvement / Standardization Participate in process improvement initiatives, as applicable Participate in safety database/PV system upgrade activities such as defining user requirements and conducting user acceptance testing Desired Skills & Competencies Good working knowledge of PV regulations including FDA, EU & local requirements. Strong data analysis and report writing skills Excellent teamwork and interpersonal skills Excellent time management and organizational skills Good knowledge of computer applications and software, including MS Word, Excel, PowerPoint etc. Qualification M. Pharm (Pharmacology) or equivalent with 3 to 7 years of experience in pharmacovigilance with experience in writing and reviewing PV Medical Writing Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com