{"id":1177431,"url":"https://alion.io/job/iqvia-csr-document-specialist","title":"CSR Document Specialist","company":{"id":4918,"name":"IQVIA","domain":"iqvia.com","url":"https://alion.io/company/iqvia","size_band":"5000+","is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":441,"ghost_share":0.002,"stale_share":0.873,"repost_share":0.016,"time_to_fill_p50_days":17,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Warsaw, Poland","Lisbon, Portugal","Sofia, Bulgaria","Romania"],"countries":["PL","PT","BG","RO"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":32000,"max_usd":58000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":29},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"SharePoint","optional":true}],"status":"live","first_seen_at":"2026-09-24T12:07:31Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-09-24T20:18:12Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Job Overview\nThe Clinical Study Report (CSR) Document Specialist is responsible forthe coordination, formatting, quality control, document management, and finalization of Clinical Study Report appendices for assigned studies. This role works closely with TMF Managers, Study Leads, Medical Writers, Biostatisticians, Clinical Operations, Regulatory Affairs, Data Management, and Quality teams to ensure that clinical study documentation is accurate, compliant, submission-ready, and delivered according to project timelines.\nThe CSR Document Specialist plays a critical role in supporting the preparation and maintenance of clinical documents in compliance with ICH-GCP guidelines, company SOPs, regulatory requirements, and industry standards.\nKey Responsibilities\nCoordinate the development, compilation, review, and finalization of Clinical Study Report (CSR) appendices.\nLead the CSR appendices kick off meeting and define the timelines together with the CSR sub team.\nFormat CSR appendices according to company templates, style guides, and regulatory requirements.\nDevelopment of the Financial Disclosure (FD) and BIMO module for submission studies as required.\nMaintain version control throughout the document lifecycle.\nPerform comprehensive quality control (QC) checks on CSR appendices.\nEnsure documents comply with established SOPs, ICH guidelines, and submission standards.\nSupport document review workflows and approval processes.\nVerify submission-ready formatting and publishing requirements.\nCoordinate timelines for document development, review cycles, and approvals.\nMonitor project milestones and escalate risks that may impact delivery timelines.\nSupport inspection and audit readiness activities.\nMaintain document repositories and archival records.\nEnsure documentation is stored and managed within electronic document management systems (eDMS).\nFollow data integrity and confidentiality requirements.\nIdentify and implement the improvements of processes to enhance quality of the TMF documents for relevant CSR appendices\nContribute to process optimization initiatives.\nEducation\nBachelor's degree in Life Sciences, Pharmacy, Nursing, Health Sciences, Biotechnology, Medical Communications, or a related discipline.\nExperience\n2-5 years of experience in:\no Clinical document management\no Medical writing support\no Regulatory operations\no Pharmaceutical, biotechnology, or CRO environments\nExperience supporting Clinical Study Reports and regulatory documentation.\nPreferred Qualifications\nFamiliarity with ICH E3 Clinical Study Report guidelines.\nKnowledge of Good Clinical Practice (GCP) requirements.\nExperience with electronic document management systems (Veeva Vault, Documentum, SharePoint, or similar).\nExperience supporting regulatory submissions and publishing activities.\nIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com\nIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.\nThe potential base pay range for this role, when annualized, is 171.500,00 zł - 318.500,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.","description_format":"text","description_chars":4162,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care"],"lifecycle":[{"event":"open","at":"2026-09-24T12:07:31Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":17,"reasons":["conf:0","win:early","comp:junior,brand"],"computed_at":"2026-09-24T21:06:14Z"},"pay":null,"html_url":"https://alion.io/job/iqvia-csr-document-specialist","json_url":"https://alion.io/job/iqvia-csr-document-specialist.json","meta":{"generated_at":"2026-09-24T21:06:14Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}