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Document Specialist I

2+ years
Not Disclosed
10 March 9, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Document Specialist I

Location: India (Remote) | Additional Location: Mumbai, India

Job Overview:

The Document Specialist I is responsible for compiling, formatting, quality-checking, and publishing clinical study reports and related documents in compliance with regulatory guidelines. This role requires expertise in regulatory submission formats, publishing software, document management, and quality control.

Key Responsibilities:

Compilation & Publishing:

  • Compile appendices for clinical study reports in accordance with regulatory requirements.
  • Ensure accurate formatting, hyperlinking, and navigability in documents.
  • Utilize publishing software to generate electronic deliverables.
  • Work with clinical and project leadership teams to complete documentation.
  • Coordinate production and distribution of draft and final documents.

Quality Control:

  • Ensure documents meet regulatory and client guidelines before submission.
  • Perform final reviews of formatted and hyperlinked documents.
  • Verify documents for completeness, accuracy, and compliance.

Project Management:

  • Serve as contact person for compilation and publishing projects.
  • Communicate timelines, expectations, and project updates to teams.
  • Support document tracking and filing with assistance from the Medical Writing Support Coordinator.
  • Adhere to departmental procedures, client SOPs, and company standards.

Training & Compliance:

  • Attend mandatory corporate and project-specific training.
  • Assist in training and mentoring new staff when required.

Qualifications & Experience:

  • Understanding of global regulatory submission formats and industry standards.
  • Proficiency in Microsoft Word formatting, publishing software, and document structuring.
  • Strong attention to detail, organizational skills, and deadline orientation.
  • Ability to coordinate across teams and ensure high-quality deliverables.

Work Environment & Culture:

  • Inclusive, collaborative, and supportive team environment.
  • Opportunities for mentorship, career development, and leadership.
  • Exposure to a wide range of clinical research documentation.