Document Specialist I

2+ years

Not Disclosed

Mumbai

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About This Role

As a Document Specialist I at Parexel, you will be responsible for compiling and publishing clinical study reports and appendices in compliance with regulatory requirements and industry standards. You will work closely with project leads, medical writers, and internal teams to ensure accurate formatting, navigation, and delivery of high-quality clinical documents. Your role will involve the use of departmental publishing software to produce electronic deliverables, performing quality control, and managing document timelines for project teams.

Key Responsibilities:

Compilation and Publishing:

Compile appendices for clinical study reports, ensuring compliance with global regulatory submission formats, industry standards, and guidelines.
Utilize departmental publishing software to produce electronic documents, ensuring navigability features, accurate intra-document hyperlinking, and formatting according to SOPs, client, and regulatory requirements.
Perform MS Word formatting of clinical documents and insert tables if necessary, coordinating the production and distribution of draft and final documents to project teams and clients.
Organize and track delivery of all documentation, ensuring completeness and quality prior to delivery.

Quality Control:

Ensure all documents are submission-ready and meet the relevant regulatory guidelines, departmental SOPs, and style guidelines before distribution.
Provide review of draft and final documents prepared by other document specialists, ensuring internal or external distribution complies with client and regulatory standards.

Document Project Management:

Serve as the point of contact for compilation and publishing projects, assisting in negotiating deliverable timelines and resolving project-related issues.
Collaborate with study teams to ensure alignment on expectations and timelines, facilitating the approval process for document publishing.
Assist in the collection and filing of documentation for project files and client deliverables, ensuring proper filing with guidance from the Medical Writing Support Coordinator.

Training/Compliance:

Attend mandatory corporate, project-specific, and departmental training sessions.
Assist in training and mentoring new departmental staff as required.

General:

Attend departmental and company meetings as necessary, adhering to departmental procedures and requirements.
Provide administrative support as requested and complete project assignment and workload trackers on applicable software platforms.

Skills & Qualifications:

Attention to Detail: Ability to ensure the highest level of quality in document formatting and compliance.
Project Management: Strong organizational and communication skills to manage document delivery timelines and project coordination.
Technical Proficiency: Familiarity with MS Word, publishing software, and the ability to perform electronic document formatting and hyperlinking.
Collaborative: Ability to work effectively within cross-functional teams and communicate with various stakeholders.
Regulatory Knowledge: Understanding of global regulatory submission formats and industry standards.
Client Focused: Commitment to delivering high-quality documents that meet client and regulatory expectations.

Knowledge & Experience:

Relevant Experience: Prior experience in document management, regulatory submissions, or related field is desirable.
Educational Background: A degree in Life Sciences, Health, Biomedical Sciences, or a related field is preferred.

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Document Specialist I

Job Description

About This Role

Key Responsibilities:

Skills & Qualifications:

Knowledge & Experience:

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