Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Document Specialist I

Parexel
Parexel
1-3 years
preferred by company
10 Jan. 22, 2026
Job Description
Job Type: Full Time Remote 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

Job Title: Document Specialist I
Location: India (Remote) | Hyderabad, India
Employment Type: Full-Time
Company: Parexel


Job Overview

Parexel is seeking a highly detail-oriented Document Specialist I to support global medical writing and clinical research activities. This role is critical in the compilation, formatting, publishing, and quality control of clinical and regulatory documents submitted to global health authorities. The ideal candidate will have strong document publishing expertise, a solid understanding of regulatory standards, and the ability to work collaboratively in a matrix environment.

This position offers the opportunity to work on diverse clinical research documents while growing within a globally recognized clinical research organization that values learning, inclusivity, and professional development.


Key Responsibilities

Document Compilation & Publishing

  • Compile appendices for Clinical Study Reports (CSRs) in compliance with global regulatory requirements, SOPs, and client guidelines

  • Support project leads and lead medical writers to ensure documentation completeness and submission readiness

  • Apply advanced MS Word formatting to clinical documents, including tables, figures, and templates

  • Use publishing and document management software to create electronic deliverables with accurate hyperlinking and navigability features

  • Coordinate production, tracking, and distribution of draft and final documents to internal teams and clients

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

Quality Control

  • Perform thorough quality checks to ensure accuracy, consistency, and regulatory compliance

  • Review draft and final documents prepared by other Document Specialists under appropriate supervision

  • Ensure documents meet global regulatory submission standards and internal/client style guidelines

Document Project Management

  • Act as the primary contact for assigned compilation and publishing projects under departmental supervision

  • Support timeline negotiations, issue resolution, and document approval workflows

  • Participate in study team meetings and communicate document requirements, timelines, and expectations

  • Manage collection and proper filing of project documentation and client deliverables

Training & Compliance

  • Complete all mandatory corporate, departmental, and project-specific training

  • Support training and mentoring of new team members when required

General Responsibilities

  • Participate in departmental and company meetings

  • Maintain workload trackers and project assignment records

  • Provide administrative and operational support as needed


Required Skills & Competencies

  • Excellent written, verbal, and interpersonal communication skills

  • Strong attention to detail with the ability to manage multiple tasks and deadlines

  • Client-focused mindset with a flexible and proactive approach

  • Ability to work effectively in cross-functional and matrix teams

  • Advanced proficiency in MS Word and MS Office, including templates, styles, tables, and quality checks

  • Advanced skills in Adobe Acrobat and PDF processing

  • Experience with document management systems and publishing software

  • Strong understanding of grammar, punctuation, and medical/pharmaceutical terminology

  • High typing speed and advanced keyboard skills


Experience Required

  • 1–3 years of relevant experience in document processing, publishing, or clinical documentation

  • Proven experience handling multiple clinical documents such as clinical study reports, submission dossiers, and regulatory documents

  • Demonstrated productivity in document formatting and post-PDF work (approximately 15–17 pages per hour)


Education Qualification

  • Bachelor’s degree or regionally accepted equivalent in Health Sciences, Life Sciences, Pharmacy, Computer Science, Information Technology, or a related field

  • Candidates with significant hands-on experience in clinical document processing or publishing will be preferred


Why Join Parexel

  • Work on global clinical research projects with real-world patient impact

  • Structured career development with mentoring, job rotation, and learning opportunities

  • Inclusive, collaborative, and growth-oriented work culture

  • Performance-based career progression aligned with global standards