35 Medical Writer Jobs - Page 2

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Roles and 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 To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing Mumbai (Job Code # 56) b) For Position in Pune Search : Medical Writing Pune (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 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing (Job Code # 56) b) For Position in Pune Search : Medical Writing (Job Code # 57)

Urgent Opening for Senior Medical Writer @ Vimta Labs Ltd, Cherlapally, Hyderabad. Experience: 5-10 years of experience in protocol design for Clinical trials, PK/PD study design for biosimilars, ICF preparation, CRF/eCRF review Responsibilities: Experience in protocol design for Clinical trials, PK/PD study design for biosimilars, ICF preparation, CRF/eCRF review Well versed with study report writing and eCTD requirement for regulatory submission. Have to work closely with Statistician for data analysis and study results review. Handle sponsor, regulatory and ethics committee queries. Other regulatory writing experience will be an added advantage. Interested candidates can share their resumes to keerthana.rojanala@vimta.com Contact: Keerthana 9160712930

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 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 365 b) For Position in Bangalore Search : Job Code # 366 c) For Position in Hyderabad Search : Job Code # 367

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)

Job title: Lifesciences Senior Analyst (Senior Medical Writer/Reviewer) Qualifications: PhD in Biotechnology and Pharmaceutical Sciences (Life Sciences); possessing at least 3 years of experience in life sciences / biotech / pharmaceuticals environment with expertise in medical/clinical research writing Location: Mumbai (Andheri East) 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 3 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 3 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. How to Apply: Interested candidates can apply directly on Naukri or send an updated resume to sneha.singh@perusalglobal.com Warm regards, Sneha Singh sneha.singh@perusalglobal.com HR Recruitment Specialist

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 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 365 b) For Position in Bangalore Search : Job Code # 366 c) For Position in Hyderabad Search : Job Code # 367

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Job Description: Experience : 4 - 11 years of experience in Medical Writing domain. Location: Mumbai, Pune, Bangalore Salary: 8 LPA to 12 LPA To Connect WhatsApp 'Hi' @9151555419 and search for Job in Mumbai / Pune / Bangalore Roles and 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 To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing Mumbai (Job Code # 56) b) For Position in Pune Search : Medical Writing Pune (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 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing Mumbai (Job Code # 56) b) For Position in Pune Search : Medical Writing Pune (Job Code # 57)

The Candidate should have a strong experience in working with Pharmaceutical Clients & Healthcare Industry Perform requisite data mining and co-ordinate with cross-functional teams as per the requisite needs of the document Customizing products like newsletters, leave behind literatures, scientific compendiums, slide decks and booklets meant for doctors Would involve studying scientific journals, sourcing content relevant to specific requirements and rewriting & representing the same to avoid copyright issues Editing and data fact checking of content documents to ensure there are no mistakes / inconsistencies Coordination with the design team to package the scientific content in an innovative and appealing format Proper citations and referencing of documents Sending out content documents to the clients and coordinating with them for suggestions and final approvals Additional Required Skills :