30 Protocol Writing Jobs

Senior Medical Writer Experience: 3 - 7 Years Exp Salary : Competitive Preferred Notice Period : Within 30 Days Opportunity Type: Onsite (Ahmedabad) Placement Type: Permanent (*Note: This is a requirement for one of Uplers' Clients) Must have skills required : CRO, writing scientific/regulatory/ clinical documents, MS Office suite Tatvacare (One of Uplers' Clients) is Looking for: Senior Medical Writer who is passionate about their work, eager to learn and grow, and who is committed to delivering exceptional results. If you are a team player, with a positive attitude and a desire to make a difference, then we want to hear from you. Role Overview Description Company Overview Tatvacare is a cu...

Senior Medical Writer Experience: 3 - 7 Years Exp Salary : Competitive Preferred Notice Period : Within 30 Days Opportunity Type: Onsite (Ahmedabad) Placement Type: Permanent (*Note: This is a requirement for one of Uplers' Clients) Must have skills required : CRO, writing scientific/regulatory/ clinical documents, MS Office suite Tatvacare (One of Uplers' Clients) is Looking for: Senior Medical Writer who is passionate about their work, eager to learn and grow, and who is committed to delivering exceptional results. If you are a team player, with a positive attitude and a desire to make a difference, then we want to hear from you. Role Overview Description Company Overview Tatvacare is a cu...

Role & responsibilities Preparation and Compilation of Study Proposal Synopsis. Literature survey and preparation and review of Clinical Study Protocols as per sponsor and / or applicable regulatory authorities. Preparation and Compilation of Clinical Study reports. Regular interaction with the Investigators of various departments for protocol inputs. Preparation of informed consent documents and protocol associated appendices. Handling and providing responses to sponsors and regulatory queries. Responsible for Review of regulatory guidelines with the current requirements for clinical research services related activities. Review procedures for pharmacy operations. Preferred candidate profile...

As a Clinical Study Manager, you will be responsible for developing clinical study designs, writing study protocols, and monitoring plans. You will play a crucial role in training the study team on relevant aspects of clinical studies and ensuring the proper execution of statistical and data management plans. Your key responsibilities will include: - Developing clinical study design - Writing clinical study protocols - Writing study monitoring plan - Training study team on relevant parts of clinical studies - Ensuring statistical plan and data management plan are properly performed - Ensuring study risk analysis plan is properly executed - Designing CRFs (case report forms) and ensuring they...

Role & responsibilities Provide comprehensive medical and scientific expertise and oversight for clinical trials, ensuring study integrity and participant safety. Review and contribute medical input to study protocols, ensuring clinical feasibility, scientific rigor, and compliance with regulatory requirements and guidelines. Ensure strict adherence to clinical trial protocols through continuous monitoring and proactive management of ongoing studies. Prepare, critically review, and approve essential clinical trial documents across all phases, including Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), Clinical Study Reports (CSR), Safety Management Plans, Medical Management Pla...

Were Hiring for Regulatory writers Location: Bang, Hyderabad, Mumbai, Pune, Delhi NCR. Hybrid mode of work ( 2 days WFO ) Experience : 4 yrs to 12 years Role & responsibilities Seeking experienced regulatory writers to author key clinical documents (e.g., CSRs, protocols, IBs, CTD summaries) in compliance with global regulatory requirements. Must demonstrate strong scientific knowledge, lean writing practices, and the ability to lead cross-functional teams through document planning, development, and finalization. Proficiency in MS Word, document management systems, and structured content tools is essential. Ability to manage timelines, ensure consistency, and work independently or across the...

TCS is Hiring - Narrative writing location - Mumbai, Noida, Bengaluru Experience Range - 5 to 10 Interested Candidate can mail on - s.laharika@tcs.com Preferred Educational Qualification for the role - Any life science Postgraduate, BDS, MDS Skills: CSR narrative, common technical document, clinical study report, Narrative writing, investigator brochure, protocol writing Job description: 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 ...

Role & responsibilities 1.Stability Studies Management: Planning and management stability studies, Comparative Stability and Forced Degradation (FDS) Studies, Reference product age related studies of all the projects. Compilation of stability data, interpretation, and data trending. To review the data, related DRS and LNBs etc. 2. Drafting / review / approval of operational SOP, LP, SLP and Stability Protocols, Summary Sheets, Reports as required. 3. Planning and management of the IRS: Planning and management for establishment of internal reference standards. Management of IRS stability studies, issuance, compilation and trending the retrospective data of the established internal standards. ...

Role & responsibilities Prepare clinical study report of BABE studies and patient based clinical trial studies (PK end point/PD end point/clinical end point studies) on the basis of data received from clinic after completion of study as per regulatory requirement/SOPs/client standards/client approved templates. Final compilation of the project report with respected appendices as per e-CTD including Module 2 (Summary report) and Module 5(Compilation of study report, literature, appendices & BR report) and/or applicable regulatory guidelines & requirements. Submit final compilation signed report with e-CTD to client. Co-ordinate with Project Manager for report requirement, sponsor's comments &...

Role & responsibilities To prepare protocol preparation Incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same. To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable. To Prepare of the CRFs and other working documents, if applicable. To prepare documents for submission to the regulatory. Internal QC of study documents Literature Search To assist the Project Manager for feasibility assessment of study proposal. Literature survey for PK & Safety study Co-ordination with Principal Investigator (PI) and/or Clinical Investigator ...

Job Title: AGM / DGM – Clinical Trials (Protocol & Report Writing) Department: Clinical Research / Clinical Operations Minimum 10–15 yrs of relevant experience in clinical trials, protocol writing, CSR writing, and regulatory documentation

Responsibilities: Prepare clinical study reports, protocols & newsletters Design medical affairs strategies Conduct literature reviews & ICH compliance checks Write scientific documents with CRF & KOL input Protocols, abstracts, posters, manuscripts Provident fund

Role & responsibilities Prepare clinical study report of BABE studies and patient based clinical trial studies (PK end point/PD end point/clinical end point studies) on the basis of data received from clinic after completion of study as per regulatory requirement/SOPs/client standards/client approved templates. Final compilation of the project report with respected appendices as per e-CTD including Module 2 (Summary report) and Module 5(Compilation of study report, literature, appendices & BR report) and/or applicable regulatory guidelines & requirements. Submit final compilation signed report with e-CTD to client. Co-ordinate with Project Manager for report requirement, sponsor's comments &...

Job Title: Senior Medical Writer Regulatory Writing Education Requirements: MBBS / PhD / MDS / BDS / MPharm / PharmD/M.Sc/B.Pharma/B.Tech Location: Bangalore (Hybrid as applicable) Experience: 8 to12 years of experience in authoring clinical and regulatory documents supporting global filings, particularly CTD Module 2 and Module 5. Role Purpose: This role involves managing complex medical writing projects, reviewing regulatory deliverables, and mentoring junior writers. The position requires both strategic thinking and hands-on execution in support of global regulatory submissions. Key Responsibilities: Independently prepare and review regulatory documents such as clinical study reports (CSR...

Role & responsibilities To prepare protocol preparation Incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same. To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable. To Prepare of the CRFs and other working documents, if applicable. To prepare documents for submission to the regulatory. Internal QC of study documents Literature Search To assist the Project Manager for feasibility assessment of study proposal. Literature survey for PK & Safety study Co-ordination with Principal Investigator (PI) and/or Clinical Investigator ...

Role & responsibilities: Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and prese...

Role & responsibilities Overall responsibility of study. Conduction of study initiating meeting. ICF preparation / obtaining ICF from subject. Conducting clinical examination Review of study documents. Supervise study activities. Preparation of study reports. Communication with sponsor and IEC/IRB. To train other clinical staff. Preferred candidate profile Interested Candidate share resume on TeamHR.VAD@accutestglobal.com. Whatsapp on 9833402126

JOB SUMMARY: Responsible for designing and preparation of Protocol, Case report form, Informed consent document and other protocol related documents in consultation with Group-In charge and Investigators, interdepartmental and intradepartmental communication, obtaining approval of protocols from the sponsor and Ethics Committee. A. Preparation of Protocols, Informed Consent Documents, Case Report Forms, and other protocol related documents as per applicable regulatory requirements in consultation with Group In-charge, Principal Investigator, Biostatistician, Analytical Investigator, and Head of the department. B. Coordination with study personnel and other departments for protocol related is...

Minimum Qualification Requirements: Bachelors degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing(CSR/Protocol writing/IB) Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)

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 1-5 Yrs with relevant experience Interested candidates...

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 ind...

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 wa...

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 w...

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 rel...

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.