Pharma Vacancy in Inventive Health Care.

inventiveInventive  Health Clinical

Organization Overview:
Inventive  Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing
Title: Document Management Associate I | Pune
Job ID : 10251
Responsibilities :
Process clinical study documentation in accordance with SOPs, GCP, and ICH gUidelines; may include establishing and maintaining Trial Master File (TMF) repositories and performing regulatory submission and document-level publishing
Perform proactive document collection activities; may include tracking of study milestones and liaising with project team to ensure timely document submissions
Perform quality-control (QC) review of clinical and regulatory documents for compliance with inVentiv Health Clinical or client-specific requirements; provide feedback to document submitters or medical writers as appropriate
Regulatorysubmlsslon (INO/CTA, MANeCTO) and document-level publishing responsibilities may include rendering and addition of document navigation aids (e.g., bookmarks, hyperlinks, pagination, stamping); as well as compilation and publishing of Clinical Study Report (CSR) and its associated appendices per SOP or client requirements; and verifying submission readiness of document formatting per ICH/Competent Authority guidelines
Inventory and archive clinical documents and project~related materials; may include scanning and indexing documents for electronic (eTMF) studies. shipment of interim or final deliverables to sponsors or off-site storage facilities
Attend and support file audits and liaise with Quality Assurance (QA) to resolve audit findings as appropriate
Complete assignments on-time and on-budget and administrative tasks (e.g., status reports) as requested
Maintain compliance with company requirements (e.g. time tracking, SOPs)
Bachelor’s Degree; in lieu of degree. four years relevant industry~related experience in handling of pharmaceutical/biomedical regulatory and/or clinical documents
One year of relevant industry experience
Regulatory document publishing and/or records management experience, especially in clinical research field
Ability to learn and apply SOPs and government regulations pertaining to clinical study documentation. For publishing activities, familiarity with (CH, FDA, and/or CTD guidances is required and prior work on an IND, NDA. or in a regulatory affairs department is preferred
Expertise In Microsoft Office Suite and Adobe Acrobat
Familiarity with eTMF and CTMS software for document management activities preferred; familiarity with Adobe ISIToolBox or any Acrobat publishing plug-in for publishing activities preferred
Organizational, interpersonal, written, and oral communication skills
Ability to prioritize work and monitor and meet deadlines for individual assignments and departmMtal initiatives
City :Pune, India

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Pharma Vacancy in Inventive Health Care.

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