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Senior Document Quality Reviewer

Parexel
Parexel
1+ years
Not Disclosed
10 Nov. 30, 2024
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

Role: Medical Writer – Document Quality Reviewer (DQR)

As a Medical Writer at Parexel, your expertise in scientific communication and regulatory guidelines ensures the production of high-quality documents for regulatory agencies, medical professionals, and other stakeholders. You will play a pivotal role in reviewing, refining, and ensuring the accuracy of clinical and regulatory documents, collaborating closely with cross-functional teams to meet project goals. This role demands exceptional attention to detail, strong organizational skills, and a commitment to quality.


Key Accountabilities

Document Quality Control (QC):

  • Perform QC checks, including formatting, tabulation, pagination, and editorial reviews of draft and final documents.
  • Review data for accuracy, ensure scientific consistency, and confirm logical flow within documents.
  • Verify adherence to regulatory guidelines (FDA/EMA) and compliance with corporate/client SOPs and style templates.
  • Conduct thorough content and style reviews to ensure document quality.

Collaboration and Oversight:

  • Work closely with medical writers to plan and execute QC activities for complex projects.
  • Consolidate feedback from multiple reviewers and provide a unified output to medical writers.
  • Lead QC processes for large or complex projects, ensuring quality and consistency across multiple documents.

Process Excellence:

  • Contribute to the continuous improvement of departmental processes, SOPs, and guidelines.
  • Identify areas for process refinement and propose enhancements to QC workflows.

Training and Mentorship:

  • Provide training and guidance to team members to enhance QC standards.
  • Plan and oversee team workloads to ensure projects meet timelines while maintaining high-quality output.

Key Skills and Competencies

  • Communication and Collaboration:

    • Exceptional written and spoken English skills.
    • Ability to work effectively in a matrix environment, fostering teamwork and collaboration.
    • Client-focused mindset with a solutions-driven approach to challenges.
  • Attention to Detail:

    • High-level proofreading, quality control, and copyediting abilities.
    • Strong numeracy and understanding of scientific concepts; knowledge of statistics is an advantage.
  • Project Management:

    • Ability to manage multiple tasks and prioritize workload in a deadline-driven environment.
    • Advanced skills in coordinating team efforts and overseeing project timelines.
  • Technical Proficiency:

    • Expertise in Microsoft Word, including template creation and document adaptation.
    • Familiarity with Adobe Acrobat and document formatting standards is a plus.

Knowledge and Experience

  • Proven experience in the pharmaceutical industry and medical writing, including regulatory documents.
  • Comprehensive understanding of ICH-GCP guidelines and regulatory requirements.
  • Prior experience in proofreading, quality control, and copyediting is essential.

Education

  • Bachelor’s degree in Life Sciences, Health-Related Sciences, or equivalent qualifications.

Why Join Parexel?

  • Collaborative Culture: Work in a supportive and inclusive environment that values teamwork and innovation.
  • Professional Growth: Gain access to mentoring, stretch assignments, and leadership opportunities to advance your career.
  • Meaningful Impact: Contribute to the development of treatments that improve lives worldwide.
  • Flexibility: Enjoy a remote-friendly work environment and a commitment to work-life balance.

#LI-REMOTE