10 Protocol Writing Jobs

Role & responsibilities Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews. Essential Job duties and responsibilities: 1) Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Reviews content created by peers writers. 4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned. Preferred candidate profile Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality

Role & responsibilities Primary responsibilities 1. Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects. 2. Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3. Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1. Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2. Review of clinical and non-clinical overviews and summaries of CTD 3. Review of medical rationale for CT waiver applications 4. New products evaluation for development 5. Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6. Mentoring/ training team members to gain required skills to enable on-time deliverables. Required Educational Qualification: MBBS and/or MD (Pharmacology) Work Exp.: MBBS with 10-12 years of experience [OR] MD (Pharmacology) 8-10 years of experience Mandatory Skills Required: Clinical Trails, Protocol Writing, Medical Writing, Investigatioons

Role & responsibilities : Key Responsibilities Conduct medical review of study related documents Prepare high quality medical rationale documents for agency submission Periodic Safety review Medical monitoring Develop clinical rationale for new products. Competencies and exposure to succeed in the role. Previous experience in medical review of clinical study documents (trial and BA/BE). Knowledge of clinical development for different regulatory such as USFDA, IND, EMA, JFDA. Familiarity with medical coding dictionaries (e.g., MedDRA) and safety reporting Strong attention to detail and ability to work with complex medical data. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Preferred candidate profile

Role & responsibilities 1. Development and review of clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions and clinical study reports etc 2. Prepare CSRs revisions, IB updates, protocols, protocol amendments etc 3. Development and review of medical rationale for CT waiver applications 4. Support SEC meetings for clinical trials and marketing approvals by preparation of presentations & literature search 5. Work with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents 6. Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources. 7. Works closely with the study team to reach consensus on timelines for deliverables 8. Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance 9. Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes 10. Ensuring that the content, format and structure of clinical documents comply with regulatory, journal, or other guidelines 11. Reviewing and proofreading materials to check quality and scientific accuracy 12. Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system 13. Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements. Additional responsibilities 1. Development and review of clinical and non-clinical overviews and summaries of CTD 2. Development and review of marketing requests of product evaluations, comparative safety and efficacy evaluations 3. Develop manuscripts, abstracts, and PowerPoint slide decks based on in-house studies and to support marketing team. 4. Mentoring/ training team members to gain required skills to enable on-time deliverables 5. Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed 6. Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations

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 2-6 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