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Document Specialist I

0-2 years
Not Disclosed
10 April 4, 2025
Job Description
Job Type: Remote 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 (Medical Writing Department)

Company:

Parexel

Location:

Remote / Global (unspecified)

Job Type:

Full-time


Job Summary:

As a Document Specialist I at Parexel, you will support medical writing and regulatory teams by compiling, formatting, and publishing clinical research documents. This role ensures high-quality, submission-ready materials compliant with regulatory and client standards. You’ll work closely with cross-functional teams and contribute to document project management, quality control, and training within a collaborative, patient-focused environment.


Key Responsibilities:

Compilation and Publishing:

  • Compile appendices for clinical study reports (CSRs) in line with regulatory requirements.

  • Format documents in MS Word and insert tables/figures per SOP/client/regulatory guidelines.

  • Use publishing software to produce electronic deliverables with accurate hyperlinks and navigability features.

  • Ensure high quality and completeness of documents before distribution.

  • Provide document and software-related support to Medical Writing Services (MWS) staff.

Quality Control:

  • Review and finalize documents for submission-readiness.

  • Conduct quality checks and ensure compliance with regulatory and client style guidelines.

  • Review draft/final documents prepared by other Document Specialists (under supervision).

Document Project Management:

  • Serve as the Document Specialist contact for assigned projects with departmental supervision.

  • Coordinate project timelines and document expectations within study teams.

  • Track delivery and organize project documentation with support from the Medical Writing Support Coordinator.

  • Support financial and contractual management under guidance.

Training & Compliance:

  • Complete all required corporate, departmental, and project-specific training.

  • Mentor and support onboarding of new departmental staff as needed.

General:

  • Attend meetings, track workload, and comply with documentation procedures.

  • Provide administrative support if required.


Success Profile – Soft Skills:

  • Adaptable

  • Strong communicator

  • Detail-oriented

  • Insightful

  • Consistent

  • Deadline-driven


Career Development at Parexel:

  • Continuous learning via mentoring, shadowing, rotations, and leadership opportunities.

  • Promotion and development guided by global standards and personal development plans.


Why Join Parexel?

Parexel fosters a culture of inclusivity, collaboration, and purpose. Your work will help bring life-changing treatments to patients while supporting your professional growth in a global, patient-centered organization.