Document Specialist I
Location:
India, Remote
Additional Locations: India-Mumbai-Remote
Category: Medical Writing
Job ID: N/A
About This Role:
Parexel is seeking a Document Specialist I to join its team, providing support in the compilation, publishing, and quality control of clinical study documents. This role involves working with the project lead and medical writers to ensure clinical documents meet regulatory standards, are formatted appropriately, and are submission-ready. The Document Specialist I will manage the organization, production, and distribution of clinical documents while ensuring compliance with guidelines and deadlines.
Key Responsibilities:
Compilation and Publishing:
Compile appendices to clinical study reports in compliance with regulatory requirements.
Use publishing software to produce electronic deliverables, ensuring navigability and intra-document hyperlinking.
Perform MS Word formatting of clinical documents, including inserting tables when requested.
Coordinate production and distribution of draft and final documents to the project team and client.
Ensure all deliverables are complete and of high quality before delivery.
Quality Control:
Review documents to ensure they are submission-ready and comply with regulatory guidelines and SOPs.
Provide review of draft and final documents prepared by other Document Specialists before distribution.
Document Project Management:
Serve as the contact for compilation and publishing projects, supporting timeline negotiations and resolving project-related issues.
Communicate document requirements and expectations, attend team meetings, and manage the approval process according to client or internal guidelines.
Perform documentation collection for project files and client deliverables, ensuring proper filing.
Training and Compliance:
Attend mandatory training and assist in mentoring new departmental staff.
Ensure compliance with corporate, project-specific, and departmental procedures.
General:
Attend departmental and company meetings as required.
Provide administrative support when requested.
Skills and Qualifications:
Strong understanding of global regulatory submission formats and industry standards.
Familiarity with departmental publishing software and MS Word formatting.
Good organizational skills, attention to detail, and the ability to work independently.
Good communication and time management skills.
Ability to work in a fast-paced environment and manage multiple tasks effectively.
Education:
Bachelor’s Degree or equivalent (Life Sciences or related fields preferred).
Andra Pradesh :
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Dún Laoghaire |Meath :
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China | Quarry Bay |Hubei :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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North Ostrobothnia :
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