Documentation Specialist

Hyderabad, INPosted Jul 14, 2026
Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsDocumentation SpecialistHyderabad - TS - IN No longer accepting applications.Job IDR1604158Date posted07/02/2026DepartmentNot ApplicablePosition Summary: Facilitate CARA structure management, submission-readiness formatting and publishing of regulatory documents including clinical study reports, investigator Brochures, safety aggregate reports, and clinical protocol documents.Duties/Responsibilities:Partner with GSRD and external authors for CARA structure assembly and document publishing of protocol and submission documents.Provide guidance and troubleshooting assistance to GSRD and external authors in PRISM/CARA, Core Template, submission readiness formatting and publishing work processes.Assist cross-function business partners with RLCP (Report level content Planning), SRC formatting and publishing for protocol and submission related documents.Remediate externally authored Word files for submission readiness and manage PRISM import and publishing workflows.Facilitate collection and review of ICH non-data driven appendices for CSRs.  Assist cross functional business partners in defining submission-ready requirements for externally authored regulatory documents.Contribute to coordination, compilation and/or authoring of select protocol and submission documents.Qualifications and Experience: Minimum of BS/BA degree with approximately 1-2 years of regulatory documentation experience in electronic document management systems, submission readiness formatting and publishing work flowsProficiency in desktop applications. word template macros, model documents and submission readiness formatting for creation of eCTD compliant regulatory documents.Proficiency in Acrobat and ISI toolbox usage in creation and remediation of eCTD compliant regulatory documents.Proficiency in an electronic document management system for assembly and management of regulatory documents.Understanding of document publishing processes across document typesAbility to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skillsEffective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organizationPosition Summary: Facilitate CARA structure management, submission-readiness formatting and publishing of regulatory documents including clinical study reports, investigator Brochures, safety aggregate reports, and clinical protocol documents.Duties/Responsibilities:Partner with GSRD and external authors for CARA structure assembly and document publishing of protocol and submission documents.Provide guidance and troubleshooting assistance to GSRD and external authors in PRISM/CARA, Core Template, submission readiness formatting and publishing work processes.Assist cross-function business partners with RLCP (Report level content Planning), SRC formatting and publishing for protocol and submission related documents.Remediate externally authored Word files for submission readiness and manage PRISM import and publishing workflows.Facilitate collection and review of ICH non-data driven appendices for CSRs.  Assist cross functional business partners in defining...

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