169 Scientific Writing Jobs - Page 6

Roles & Responsibilities Author regulatory submission documents such as: Clinical Study Reports Investigator Brochures Responses to Questions Protocols and Protocol Amendments Informed Consent Forms Table of All Studies Clinical Overview Addenda eCTD Module 2 Clinical Summary Documents Briefing Documents Pediatric Investigation Plans Other regulatory documents as assigned Conduct formal review and approval of authored documents, adhering to SOPs Manage regulatory writing activities for product submissions under supervision, including new and supplemental drug applications/biologics license applications Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) Provide functional area input for Global Regulatory Plan and team goals Collaborate with contract and freelance writers as needed Participate in training and mentoring junior medical writers Engage in departmental and cross-departmental initiatives Generate document timelines with team input Stay updated on relevant professional information and technology Basic Qualifications Doctorate degree OR Master's degree with 46 years of directly related experience OR Bachelor's degree with 68 years of directly related experience OR Diploma with 1012 years of directly related experience Preferred Functional Skills Proficient with Microsoft Word and Office programs Strong knowledge of scientific/technical writing and editing Thorough understanding of clinical development processes for new compounds Ability to understand and follow complex SOPs, guidance documents, and work instructions Substantial knowledge of ICH and Good Clinical Practice (GCP) guidelines and requirements Soft Skills Excellent written and oral communication skills with strong attention to detail Demonstrated leadership abilities within a team environment involving negotiation, collaboration, and analytical judgment Effective time and project management skills Self-motivated with drive and perseverance to achieve results

Purpose: Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly. The purpose of the Scientific Communications Associate - Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to protocols, protocol amendments and addenda and ICFs). Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. 1. Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration. Conduct effective document initiation meeting to ensure authoring team alignment and understanding. Build scientific-based rationale that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner. Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. Coordinate expert/scientific reviews, collate reviewer s comments, adjust content of document as required based on internal/external input, and prepare final version. Ensure and coordinate quality checks for accuracy. Exhibit flexibility in moving across development and preparation of multiple document types. Influence or negotiate change of timelines and content with other team members. Work with internal and external experts to develop and prepare presentations. As needed, may build and manage relationships with vendors/alliance partners. 2. Project and Stakeholder management Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents. Build/communicate credible writing project timelines. Anticipate and mitigate risks to delivery Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. Effectively communicate project status to stakeholders 3. Knowledge and Skills Development Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. Maintain and enhance knowledge of regulatory guidelines and publication guidelines. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews. Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms. 4. Knowledge Sharing Provide coaching to others by sharing technical information, giving guidance, answering questions. Recognized for technical expertise in specific document development. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. Provide database and other tool (e.g., document management systems) expertise. Minimum Qualification Requirement: Bachelor s degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing. Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process). . .

Summary As a Regional Medical Lead, you ll drive medical strategy, evidence generation, and cross-functional collaboration to improve patient access and outcomes. Your expertise will shape clinical development and ensure innovative therapies reach those who need them most. About the Role Key Responsibilities Lead the development and execution of local medical strategies aligned with global and franchise objectives. Identify strategic drivers and shape the patient journey and stakeholder engagement plans. Co-develop integrated evidence plans and oversee local execution across the product lifecycle. Drive real-world evidence generation and support innovative study designs to improve patient outcomes. Provide expert medical input on pipeline programs, disease areas, and approved brands. Collaborate cross-functionally to ensure compliant and impactful medical and promotional activities. Represent Novartis in scientific forums, publications, and external stakeholder engagements. Support training, regulatory submissions, and governance of external funding and patient programs. Role Requirements Advanced degree in health sciences (MBBS, MD, BDS, PhD, or PharmD) as per local regulations. Minimum 1-2 years of experience in the pharmaceutical industry. Strong clinical and research background with knowledge of Good Clinical Practice. Proven ability to translate scientific knowledge into strategic medical plans. Excellent communication, collaboration, and stakeholder engagement skills. Strong planning, organizational, and scientific writing capabilities. Fluency in English; proficiency in local language preferred. Desirable Requirements Experience with innovative study designs such as randomized controlled trials combined with real-world evidence. Proven track record of co-creating and executing protocols with healthcare system stakeholders. Why Novartis: You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

correct Job description: If you are interested, please call 9094200201 and email your resume to rajesh_r@jrkresearch.com. Location: Kundrathur, Chennai Role: Copy editor and content writer Proofread and correct scientific and marketing communication about JRK requires products and packaging materials like labels, cartons, etc., before printing Should give content to promote on social media. Able to handle social media posting the content, videos and the blogs and need to have a track on the posting and boosting the posts. Submit work to the concerned heads for input and approval Coordinate with designers to execute the ideas planned for designing promotional materials, gifts, communication and packaging materials. Need to coordinate the design of creatives for social media posts and product videos. Update website content as needed. Write clear marketing language to promote our products Should write blogs. Proofread and edited blog posts before publication Must require excellent written communication skills in English Ensure all round consistency (style, fonts, images) Should be able to train the marketing teams for products Should be able to prepare the PPTs for product communications Should be able to commute between the Head Office and Corporate Office Qualification: Biotechnology/B.Pharmacy/BSC /MSC Life Sciences.

Role & responsibilities Proficiency in organizing and communicating clinical information Excellent attention to detail, consistency, clarity and scientific rigor Continuous improvement and growth mindset Ability to work in a fast-paced and changing environment Accountable, focused, precise attitude Customer-service mentality and can-do attitude Exceptional command of written and spoken English at a professional level with the ability to write clear, concise and grammatically flawless medical/scientific content. Job Responsibilities 1. Works closely with cross-functional project teams to independently author scientifically accurate, comprehensive and compliant documents, including but not limited to clinical study reports, clinical study protocols, manuscripts, informed consent forms, patients narratives, abstracts, posters, oral presentations, etc 2. Manages the collection, consolidation and integration of comments/feedback from internal and external reviewers to efficiently finalize assigned writing projects 3. Performs thorough quality control checks, including copyediting, proofreading, and cross-verification of data within clinical documents and against source TFLs to ensure accuracy, consistency, and compliance with regulatory standards. 4. Ensure that the assigned deliverables strictly adhere to regulatory guidelines (e.g., ICH-GCP, EMA/FDA requirements), publication guidelines (ICMJE, GPP, journal/congress-specific requirements), client specifications, and Veeda's quality standards for content, format, and structure. 5. Streamline the review process by identifying and mitigating potential conflicts early, enabling the timely completion of high-quality deliverables. 6. Provide supervision and technical advice to other medical writers in the team and new writers joining the team, as required. 7. Apply broad therapeutic knowledge to adapt writing style and content for different disease areas and target audiences 8. Conduct literature reviews on assigned therapeutic areas and provide scientific support across departments throughout the clinical study lifecycle, ensuring adherence to timelines and project requirements. 9. Quickly assimilate new therapeutic area information to support emerging project needs 10. Maintain awareness of evolving guidelines and standards across relevant therapeutic fields 11. Provide support to Medical Writing department activities as needed

What you will do Let’s do this. Let’s change the world. In this vital role you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles & Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) May provide functional area input for Global Regulatory Plan and team goals May work with contract and freelance writers May participate in training and mentoring of junior medical writers May participate in departmental and cross-departmental initiatives, as appropriate. Generate document timelines, with team input Keep abreast of relevant professional information and technology What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of directly related experience OR Bachelor’s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Functional Skills: Proficiency with word processing and other Microsoft Office Programs Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds; Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions; Understanding and application of principles, concepts, theories and standards of scientific/technical field. Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance’s and requirements. Soft Skills: Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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 an accommodation. 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

Skill required: Marketing Operations - Medical Affairs Designation: Copywriting Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designDesign, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for Medical ReviewMedical MonitoringContent CreationProblem-solving skillsAgility for quick learningResults orientationCommitment to qualityWritten and verbal communicationClinical Data Review Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Postdoctoral Research Fellowship AI in Power and Energy Systems @ Coimbatore Postdoctoral Research Fellowship AI in Power and Energy Systems @ Coimbatore - Amrita Vishwa Vidyapeetham Postdoctoral Research Fellowship AI in Power and Energy Systems @ Coimbatore Postdoctoral Research Fellowship AI in Power and Energy Systems @ Coimbatore Amrita School of Artificial Intelligence, Coimbatore, is inviting applications for a Postdoctoral Research Fellow to work on AI and Machine Learning applications in Power and Energy Systems. For details contact : s_rahul1@cb. amrita. edu Postdoctoral Research Fellowship AI in Power and Energy Systems Qualification Ph. D. in Electrical Engineering, Artificial Intelligence, Computer Science, or related fields. Strong background in machine learning, deep learning, or data-driven modeling. Solid understanding of power systems, smart grids, or energy infrastructure. Proficiency in MATLAB and Python, including popular ML libraries (TensorFlow, PyTorch, Scikit-learn). Strong communication and scientific writing skills. Job description The Postdoctoral Research Fellow will be part of a dynamic research team working at the intersection of machine learning, power and energy systems, and sustainable technology. The focus will be on applying data-driven methods to solve real-world challenges in smart grids, renewable integration, electric vehicles, and energy resilience. Last date to apply 31 July 2025 For details contact s_rahul1@cb. amrita. edu Thank You for contacting us! Well be in touch shortly. Add File or drop files here Upto 500kb | doc, docx & PDF format only Extra curricular activities To confirm your request , please check the box to let us know you are human

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Hi We are looking to hire Narrative Medical Writers for our Client. Please go through the JD and Apply Role : Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements 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 # 365 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 366 c) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 367

Must Published 3-4 paper in SCI/Scopus Q1/Q2Unpaid Journals with their Expertise Must be able to write and can arrange the data by themselves in such manner so that paper can be published easily Required Candidate profile Must Be Phd Must Be published 3-4 Journals in sci unpaid Must be able to write the good quality paper

Hi, We are hiring for the Leading ITES Company for Medical Writing Role. 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 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

Hi We are Hiring for the job role of Medical Writer 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 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

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. 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 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

Data Search & Analysis on the drug discovery and development Creating technology reports Kindly provide minimum two references with resume Required Candidate profile Keen interest in drug discovery, API Good Knowledge of organic chemistry Good Communication Skills

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work Job Description: Act as SME for safety business and track industry trends relevant to safety Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry Build partnership with senior leadership across the industry in Safety and PV Represent the company in trade conferences, speaker sessions etc. Identify and build potentially synergistic partnerships to expand client and service footprints Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Must Have - MBBS/ MD with a minimum of 8-10 years of experience in drug safety or a related field; Master/Diploma in Management degree is added advantage - Experience in the pharmaceutical industry, preferably in drug safety, pharmacovigilance, or clinical development - Knowledge of pharmacology, toxicology, and clinical trial methodology - Understanding of FDA and international regulatory requirements related to drug safety and pharmacovigilance - Strong analytical and problem-solving skills - Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams - Demonstrated ability to prioritize tasks and manage multiple projects simultaneously - Proficiency in data analysis tools (e.g., Excel, SAS) and safety databases (e.g., Argus, ARISg) - Good communication skils and relationship building skills - Act as SME for safety business and track industry trends relevant to safety - Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions - Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities - Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry - Build partnership with senior leadership across the industry in Safety and PV - Represent the company in trade conferences, speaker sessions etc. - Identify and build potentially synergistic partnerships to expand client and service footprints - Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Good to have EQUAL OPPORTUNITY

We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. The Scientific and Medical content teams at Indegene work on different projects across the product life-cycle from regulatory, safety, medical affairs and commercial solutions for our clients. The team leverages the clinical and scientific knowledge and applies to various business problems to reach to various target audiences like the physicians, patients across different therapy areas. In light of this, the role holder in Content Solutions would get an opportunity to learn and partner with healthcare clients on various projects. Summary: Indegene is looking for a scientific writer and reviewer to serve as a quality medical reviewer/technical reviewer for promotional, disease education and training materials for a pharmaceutical client. Responsibilities: Perform a procedural review to ensure all MCA guidelines are followe'd to include data accuracy review, content supported by the references cited, and data and information are correctly interpreted from the reference. Deliver and be able to review content that is rated high on depth, comprehensiveness, quality and timelines - within a short span of time. Cross-check scientific information against cited references and ensure accuracy (fact checking) Ensure consistency with approved product labelling and check for any off-label communication. Possess a high-level understanding of MCA guidelines for review of materials. Validate reference quality and standards and if the referencing is contextually accurate Cross check consistency in reference citation style Verify presence of essential information like brand and generic names, AE reporting, presence of API etc Interact and defend content based on scientific evidence and facts. Demonstrate passion to learn and write for different therapy areas and markets with strong written and verbal communication / presentation skills Liaise with client medical and other stakeholders and provide clarification on content or references. Ensure quality of review and submission of the jobs within the agreed upon time frame. Prioritize assets for review as per request from Medical Affairs/Medical Review Leads Keep themselves updated on different products TAs Requirements: Advanced bioscience or pharmacy/medical qualification. Excellent communication ability, both verbal and written. Strong scientific acumen and ability to grasp complex therapeutic areas. Total experience - 0-2 years of pharmaceutical industry experience which includes medical affairs/medical information related content writing, review, literature reviews, publications support, promotional/non-promotional medical review.

The Associate Medical Expert in TCO (Translational Clinical Oncology), is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical support for assigned aspects of a global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) and / or Medical Expert TCO (Translational Clinical Oncology) is a department under Biomedical Research division, and is responsible for designing and executing out early phase (first in human) clinical studies in patients with cancer. It acts as a bridge between drug discovery and late phase clinical development and strives to deliver transformative new medicines for oncology conditions. About the Role Major accountabilities: Provides medical support to Clinical Program Leader (CPL) and / or Medical Expert. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (eg, Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. Contributes to clinical/scientific elements of TCO - related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc Contributes to the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Supports conduct of dose escalation meetings, investigator teleconferences and site initiation visits etc Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Advocate continuous improvement of quality Key performance indicators: Evidence of high-quality medical input to assigned studies to ensure execution according to timelines and ensuring adherence to international and local regulations. Evidence of quality medical and scientific review of clinical trial data Demonstrates excellent scientific writing skills to enable the development of high-quality documents including but not limited to clinical trial protocols, trial reporting (eg CSR), and regulatory documents (eg IB, DSUR). Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (eg, internal medicine / pharmacology etc) with medical council certification required. Experience in hematology / oncology preferred. Work Experience: At least 2 years of pharmaceutical/biotech industry experience or at least 4 years of clinical practice experience in the hospital setting Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to clinical or preclinical projects. Clear written and verbal expression of ideas, an active/proactive communicator. we'll-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Regulatory Compliance. Languages : English.

The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. Key Responsibilities : Strategy and delivery of PCS deliverables for products under development and in-market. Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products. Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts. Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives. Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines. Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books. Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables. Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement. Act as a nonclinical scientific liaison to Submissions Documentation (SD) vendor supporting nonclinical submission document management. Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations. Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines. Essential Requirements: PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment Understanding of GLP principles in nonclinical studies and submission writing. Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development. Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred. Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred. Registration and certification with one of the International Toxicology registers. Desirable Requirement: Animal Models ,Communication Skills, Data Analysis. Ethics ,Laboratory, Problem Solving. Regulatory Compliance. Research. Risk Assessment. Toxicology

Review of promotional and medical communication materials (for various client products) and ensure the content in these materials is medically accurate, scientifically rigorous, truthful and balanced, relevant to product and therapy area, compliant to various pharma regulations and guidelines and is supported by authentic and up to date references. Develop and update content for various medical materials, perform literature search to identify appropriate references to support creation/update of scientific content, track and audit assets for various purposes. Develop and review content for various deliverables meeting quality requirements as per client satisfaction metrics, within assigned timelines and with guidance from the manager. The tasks will be carried out as per assigned processes, guidelines, and SOPs with help of tools and platforms specified by the client and the manager. Responsible to follow the best practices in the department regarding - processes, communication (internal & external), project management, documentation, and technical requirements like - language, grammar, stylization, content search, summarizing, data conflicts and referencing. Participate in assigned training programs and work on assignments as per requirement. Participate in client calls as per project requirements. Compliance to quality, confidentiality and security; Adhere and follow quality systems, processes and policies; Comply to training and specifications Key Requirements: EXPERIENCE: Minimum 2 to 5 years of experience EDUCATION: MD/MDS/PhD with Post Doc (or experience)/MBBS with experience . Location: Hyderabad, Banglore, Mumbai, Delhi/Ncr, Pune Interested Candidate Please Apply - India.hr@infinitysts.com

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

Design and deliver engaging physics courses, including lectures, labs, and seminars.Provide academic advising and career guidance to students.Support student organizations, outreach programs, and competitions related to physics.