8 Protocol Writing Jobs

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

Responsibilities: * Prepare clinical study reports and protocols. * Ensure compliance with ICF and ICH-GCP guidelines. * Collaborate on clinical research projects. * Write medical communications for regulatory submissions. Provident fund

Design and execute clinical studies per medical device standards; collaborate with teams; prepare protocols and reports; liaise with CROs/sites; support regulatory submissions; maintain detailed records. Should be skilled in PCR, ELISA. Required Candidate profile Strong in molecular biology, clinical study design, protocol writing, documentation. Skilled in PCR, ELISA, and data analysis. Knowledge of clinical regulations. Good at reporting and communication.

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

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up *Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M. Pharm (Pharmacology) with 2-8 Yrs of Relevant Experience Interested candidates can share their CVs on vilshashah@torrentpharma / meghamaheshwari@torrentpharma.com

Job Location: Bangalore Department: Medical Writing About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation . Role: Medical Writer Key Responsibilities: Independently develop and finalize clinical and scientific documents for different regulatory submissions such as (but not limited to) Bioanalytical reports, Clinical Study Reports (CSRs), part of Electronic Common Technical Document (eCTD) modules, covering various therapeutic areas, and phases of clinical research Collaborates with internal and external clients to support and enable effective communication resulting in operational excellence Effectively manages medical writing and review processes to deliver quality projects in agreed timelines Ensure compliance to applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings Follow any other instructions and perform any other related duties, as assigned by the supervisor. Performs literature search/review as necessary to obtain background information for developing scientific content Educational Qualification: Graduate in Life Sciences Masters in Life Science Experience: 7-10 Years Behavioural Skills: Good communication Quick learner Adapt to change Time management Professionalism Technical/functional Skills: • Ability to comprehend scientific information • Good understanding of clinical research. • Knowledge of working on MS word, PPT etc. • Attend training on environment, health, and safety (EHS) measures imparted company Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up *Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M. Pharm (Pharmacology) with 2-6 Yrs of Relevant Experience Interested candidates can share their CVs on meghamaheshwari@torrentpharma.com / vilshashah@torrentpharma

Senior Medical Writer in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 10-15 years in Medical writing field in Clinical Research BA/BE studies CTC : As per market standards Report to: Principal Investigator Clinical Primary Responsibilities: 1. Ensures that Good Clinical Practices (GCP) and NDCT (New Drugs and Clinical Trials Rules) are followed. 2. Writing and developing BA/BE and clinical trail protocols. 3. To perform literature search and preparation of feasibility. 4. Preparation of study specific informed consent forms (ICFs), case report forms (CRFs) and blood sample forms. 5. Preparation of clinical study reports (CSRs), DBE/summary tables, CS-BE tables and module 2.7.1 (M 2.7.1) and other required documents in compliance with applicable regulatory guidelines. 6. Co-coordinating departmental activities to ensure timely delivery of the final reports with quality. 7. Co-coordinating and liaising with operational team (internal & external) as necessary. 8. Collection of demographics, AEs, SAEs, subject disposition, protocol deviations, dosing information from CRFs and TMFs, that are required for the preparation of CSR. 9. Narration of SAEs. 10. Preparation of eCRF (creation of forms, study registration and other required fields) before study execution. 11. Monitoring team for achieving TAT. Secondary Responsibilities 1. Review of Tables and listings (TLs) 2. Ensures that Case Report Forms (CRF) are reviewed in a timely manner and submitted for further process. Interested candidates can share their resumes to keerthana.rojanala@vimta.com Contact: Keerthana