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1.0 - 5.0 years

4 - 7 Lacs

Chennai

Work from Office

correct Job description: If you are interested, please call 9094200201 and email your resume to rajesh_r@jrkresearch.com. Location: Kundrathur, Chennai Job Definition : i. To be responsible for converting scientific and technical product information and studies of medicaments and cosmetic preparations into requirements that suit various use situations for marketing and sales communications to medical practitioners, customers in print, digital and offline modes. ii. To supervise and assist in creative design and ensure accuracy and completeness of such promotional and communication materials within defined timelines and coordinate with relevant internal and external resources. iii. To present the outcomes of the above to sales and marketing teams from time to time. Skill : i. Strong reading, writing and spoken communication skills in English and atleast one or two regional languages ii. Proficiency in Microsoft Office applications including MS PowerPoint, MS Word, MS Excel iii. Analytical skills to interpret technical and outcome data and present in simple forms like Graphs and tables iv. Multi-tasking skill v. Ability to assemble/collate information from multiple sources and simplify/present for the intended purpose/audience vi. Willingness to learn, adapt and adopt. vii. Proofreading /Attention to detail Knowledge /Experience : i. Reasonable familiarity with human physiology, research studies, diseases and disorders, treatment options ii. Prior experience in support activities in pharmaceutical/hospital/ research establishments in related areas including preparation of promotional materials like flyers, brochures, banners etc both print and digital iii. Two to five years of relatable experience. Qualification: Masters in Biotechnology/Pharm-D /MSC Life Sciences.

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3.0 - 6.0 years

3 - 6 Lacs

Pune

Hybrid

Job Description As a Clinical annotator at Verantos, you will be instrumental in annotating medical documents including details on medical conditions, medications, laboratory tests or questionnaires for real-world evidence projects. You will focus on reviewing the medical notes for its accuracy and completeness. Responsibilities Annotate medical documents using annotation tools. Review medical documents for their completeness. Identify and report any protected health information in the annotated medical documents to maintain patient privacy. Manage specialized annotation requests and tasks with changing guidelines and tight deadlines. Assess your metrics to boost and improve productivity. Report and document any issues with annotation tools and annotated documents to the development team when necessary. Provide feedback for improvements to the existing annotation tool to increase annotation throughput and quality. Contribute to the enhancement of workflow processes. Qualifications Bachelor's or above in pharmacy, nursing, medicine, or social work and at least a year of clinical experience in the field. At least 3 years of work experience as a medical annotator. Ability to work on multiple projects in a fast-paced environment Demonstrate flexibility, initiative, professionalism, and the ability to work under pressure with minimal supervision.

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6.0 - 11.0 years

10 - 15 Lacs

Navi Mumbai, Maharashtra, India

On-site

Outpace Consulting Services is seeking a Regulatory Medical Writer with expertise in Life Sciences for a leading ITES company. In this role, you'll be responsible for developing clear, accurate, and well-structured medical and scientific documents specifically tailored for regulatory authorities. This involves translating complex clinical and scientific data into compliant and understandable content for various regulatory submissions and clinical trial documentation. You'll collaborate closely with researchers and regulatory teams, ensuring all information is scientifically sound, adheres to industry guidelines, and meets the needs of the target audience. Key Responsibilities: Regulatory Document Preparation: Prepare and review a wide range of clinical documents for regulatory submissions, including but not limited to Protocols, Clinical Study Pharmacology Reports, Clinical Study Reports, Narratives, Post-Approval Documents, Clinical Summary of Safety, Clinical Summary of Efficacy, and Common Technical Document (CTD) Modules across various Therapeutic Areas. Quality Assurance & Compliance: Conduct thorough quality checks on all clinical documents, ensuring high standards for scientific content, organization, clarity, accuracy, format, and consistency, while strictly adhering to regulatory guidelines, Standard Operating Procedures (SOPs), Document Standards, and Guidance documents. Team Collaboration & Coordination: Initiate start-up meetings with Study Teams, and work closely with all internal and external study team members throughout the document development process. Effectively share project timelines to ensure smooth coordination. Data Integration & Review: Review statistical analysis plans and table/figure/listing as needed, ensuring uniformity and consistency in the scientific content of all regulatory documents. Timely Delivery & Project Support: Prepare medical writing documents within established timelines, ensuring high quality. Actively plan content, format, and timing of documents, manage report scheduling/tracking, and support assigned clinical development or project teams to meet project needs and department standards. Quality Control & Peer Review: Perform peer review and quality control review of documents within established timelines, adhering to applicable guidelines and processes using appropriate checklists. Meeting Management: Plan and organize project and non-project meetings as required. Required Qualifications: Experience: Minimum 1 year of experience with regulatory submission formats such as eCTD / NEES / Docubridge . Proven experience in making Clinical Study Reports and Clinical Summary of Safety . Education: Any Life Science Graduate . Skills: Strong writing skills, exceptional attention to detail, and a solid understanding of medical terminology and research practices. To Apply: WhatsApp Hi to +91 9151555419 . Then, follow these steps: Click on Start to Apply and fill in your details. Select the location as Other (to get multiple location options). For Mumbai , type: Job Code #56 For Pune , type: Job Code #57

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6.0 - 11.0 years

10 - 15 Lacs

Mumbai City, Maharashtra, India

On-site

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

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6.0 - 10.0 years

10 - 15 Lacs

Mumbai City, Maharashtra, India

On-site

Role & responsibilities: 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.) 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 Aggregate Safety Reports (PBRER, DSUR etc.). 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.

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5.0 - 10.0 years

7 - 17 Lacs

Mumbai, Mumbai Suburban

Work from Office

Dear Candidate, We are currently hiring for the position of Senior Medical Write r . Please find the job details below. Job title: Lifesciences Senior Analyst (Senior Medical Writer) Qualifications: PhD in Biotechnology and Pharmaceutical Sciences (Life Sciences); possessing at least 4 years of experience in life sciences / biotech / pharmaceuticals environment with expertise in medical/clinical research writing Location: Mumbai (Andheri East) Onsite Role Work timings: 10:45 am to 7:45 pm Working day: Monday to Friday Position Overview : We are seeking to recruit a Lifesciences Analyst (Medical Writer) with a PhD in Biotechnology and Pharmaceutical Sciences, possessing at least 4 years of experience in a life sciences / healthcare (therapeutics) consulting firm or similar relevant commercial experience in a biotech or pharmaceuticals environment. Experience in writing/producing medical research reports on multiple therapeutic areas, including but not limited to vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology, oncology, etc. Experience: Proven experience (minimum 4 years) as a medical writer in a biotechnology or pharmaceutical environment. Strong understanding of biotechnology, clinical development processes, multiple therapeutic areas, etc. Ability to adapt writing style to different materials and target audiences. Experience in creating medical content, preferably within an agency or biopharma environment Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills Ability to multi-task and work under defined timelines Key Responsibilities / Work Profile: 1. Research, analyze, and interpret scientific literature from research papers and scientific publications, clinical trials, company posters, regulatory filings, and company disclosures to draft a detailed research report from an investment perspective with the following content: company profile and product overview product(s) development pipeline and treatment pathways identify appropriate study endpoints, design, patient populations, and methodology existing treatment profile in the industry treatment mechanism or mechanism of actions of various drugs or therapies comparison of company pipeline with leading marketed therapies and under development alternative pathways in the industry or focused therapeutics / disease articulating clinical trial design and results identifying and recreating relevant charts/diagrams/tables from research papers and scientific publications with the help of graphics designing team and connecting the content with these charts for enhanced understanding organized and precise citations for the research material included in the report event update reports of key development news concise and strategic insights in executive summaries, allowing investors to quickly grasp the content 2. Simplify complex biotech concepts, medical and technical information for investor audiences into clear, understandable documents while maintaining accuracy and depth. 3. Follow/comply with client requirements/SOPs, style guides, client templates, client preferences (as applicable). 4. Manage multiple projects and deliver high-quality reports within deadlines. Only candidates with a PhD are eligible to apply How to Apply: Interested candidates can apply directly on Naukri or send an updated resume to sneha.singh@perusalglobal.com Warm regards, Sneha Singh HR Recruitment Specialist

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0.0 - 4.0 years

2 - 7 Lacs

Navi Mumbai, Pune

Work from Office

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

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8.0 - 13.0 years

8 - 16 Lacs

Pune

Remote

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

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5.0 - 10.0 years

8 - 16 Lacs

Pune

Remote

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

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5.0 - 10.0 years

10 - 15 Lacs

Pune, Bengaluru, Mumbai (All Areas)

Work from Office

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

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6.0 - 11.0 years

10 - 15 Lacs

Pune, Bengaluru, Mumbai (All Areas)

Work from Office

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

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4.0 - 9.0 years

10 - 15 Lacs

Mumbai Suburban, Pune, Mumbai (All Areas)

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

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4.0 - 9.0 years

10 - 15 Lacs

Mumbai, Pune, Mumbai (All Areas)

Work from Office

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 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

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3.0 - 5.0 years

5 - 13 Lacs

Pune

Remote

Role & responsibilities: • Mentors less experienced medical writers on projects, as necessary. • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. • Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. • Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. • Performs on-line clinical literature searches, as applicable. • Working knowledge of drug development process and regulatory guidelines. • Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. • Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. • Completes required administrated tasks within the specified timeframes. • Performs other work-related duties as assigned.

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1.0 - 6.0 years

10 - 15 Lacs

Bangalore Rural, Bengaluru

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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

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1.0 - 2.0 years

3 - 5 Lacs

Chennai

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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.

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2.0 - 6.0 years

2 - 4 Lacs

Noida

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We are seeking a skilled and detail-oriented Medical Content Writer to join our team. The ideal candidate will be responsible for creating accurate, engaging, and well-researched medical and healthcare content tailored to a variety of audiences including healthcare professionals, and industry stakeholders. Research and write clear, concise, and evidence-based medical content for articles, blogs, newsletters, white papers, brochures, and social media. Ensure all content is scientifically accurate, compliant with industry regulations, and aligned with the latest clinical guidelines. Edit and proofread content for clarity, grammar, and medical accuracy. Stay updated with current healthcare news, medical breakthroughs, and trends in the healthcare industry. Optimize content for SEO and digital platforms when required. Requirements: Bachelor's or Masters degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field. (Medical writing certifications are a plus.) Proven experience in medical or scientific writing. Strong research skills and the ability to synthesize complex data from multiple sources. Excellent writing, editing, and proofreading skills with attention to detail.

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6.0 - 11.0 years

10 - 15 Lacs

Navi Mumbai, Pune, Mumbai (All Areas)

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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

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6.0 - 10.0 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

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Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: 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.) 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 Aggregate Safety Reports (PBRER, DSUR etc.). 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. 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

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1.0 - 4.0 years

7 - 10 Lacs

Hyderabad, Bengaluru, Mumbai (All Areas)

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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

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1.0 - 6.0 years

10 - 15 Lacs

Bangalore Rural, Bengaluru

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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

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6.0 - 11.0 years

10 - 15 Lacs

Navi Mumbai, Pune, Mumbai (All Areas)

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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

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4.0 - 9.0 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

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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

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1 - 5 years

4 - 7 Lacs

Chennai

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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.

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6 - 10 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

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Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: 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.) 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 Aggregate Safety Reports (PBRER, DSUR etc.). 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. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

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