37 Protocol Writing Jobs

Role & responsibilities Handle minimum 2 projects per month (may vary as needed). Act as SPOC for clients for assigned and junior writers projects. Attend client meetings and coordinate with internal teams. Deliver high-quality documents and incorporate feedback. Review and mentor Junior Medical Writers; provide training and guidance. Ensure adherence to all applicable SOPs and participate in trainings. Support Senior Medical Writers in annual SOP updates . Preferred candidate profile Degree in Life Sciences/Pharmacy/Medicine. Relevant 56 years of medical writing experience. Strong communication, quality focus, and project management skills.

Position: Medical Writer I / Senior Medical Writer Experience Required: 6 to 8 years (CRO preferred / Pharma) Qualification: M. Pharm (Pharmacology) / Pharm D Location: Remote (Work from Home) Job Type: Full-time, Remote Key Responsibilities (Must-Have Skills) - Independently prepare, review, and finalize Protocols - Concept Sheets - Investigators Brochure (IB) - Informed Consent Forms (ICF) - Case Report Forms (CRF) - Ensure compliance with regulatory requirements Nice-to-Have Skills - Module 2 (CTD) Documents - Regulatory briefing documents - Manuscripts and publications - Scientific presentations / posters - Experience with global teams Role & responsibilities Act as the primary point of ...

Role & responsibilities: Study Synopsis Preparation Preparation and Compilation of study Protocol Synopsis. Preparation and review of Clinical Study Protocols as per sponsor and/or applicable regulatory authorities. Preparation of informed consonant form. Clinical Protocol Preparation Preparation of and review of Clinical Study Reports as per sponsor and/or applicable regulatory authorities. Preparation and review of Clinical study report as per sponsor and/or applicable regulatory authorities. Preparation and review of Bio Summary Tables/ clinical Summaries/CSBE for different regulatory submissions. Responsible for designing and reviewing scientific and technical inputs for pharmacokinetic ...

Senior Medical Writer - Clinical Research (BA / BE Studies) @ Vimta Labs Ltd, Hyderabad Experience: 8-12 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 an...

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 ...

Hiring for Narrative Writer-Mumbai,Pune Any Grad/PG with 5 to 10yrs in Narrative Writing in Clinical Documents, Protocols,Clinical Study Report,Narratives,Clinical StudyPharmacology Report. Salary-max 18 LPA Call Suhani-9911988552 Rukhsar-9899875055 Required Candidate profile -MW1-Clinical documents, Protocols, Clinical Study Pharmacology Report,CSR, Regulatory Affairs, Regulatory Publishing, eCTD, NEES, Docubridge. -MW2- xEVMPD, OMS,IDMP, RIM, Veeva Vault.

Responsibilities: * Prepare clinical study reports with scientific accuracy * PSUR, CTD, CSR, SPC, IB preparation * Manuscript writing * Writing patient safety narratives, safety summaries * Safety reports, Risk Management Plan

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...