At Parexel, we are driven by a shared mission to improve global health. From clinical trials to regulatory consulting and market access, every solution we provide is rooted in a deep commitment to making a difference. Each role at Parexel, including the Document Specialist I, plays a vital part in developing therapies that ultimately benefit patients. If you are passionate about contributing to meaningful work with empathy and dedication, this opportunity is for you.
Job Overview: Document Specialist I
As a Document Specialist I at Parexel, you will play a critical role in ensuring the accuracy, compliance, and timely delivery of clinical documentation. Your work will directly support the development of therapies that improve patient outcomes. This role involves collaboration with cross-functional teams, adherence to regulatory guidelines, and the use of advanced publishing tools to produce high-quality deliverables.
Key Responsibilities
1. Compilation and Publishing
- Compile appendices to clinical study reports in compliance with regulatory requirements, under the guidance of the project lead and lead medical writer.
- Collaborate with internal and external Clinical and Project Leadership teams to ensure completeness and compliance of appendix documentation.
- Utilize departmental publishing software to create electronic deliverables, ensuring navigability, accurate hyperlinking, and adherence to SOPs, client, and regulatory requirements.
- Format clinical documents in MS Word, including table insertion, and coordinate the production and distribution of draft and final documents to project teams and clients.
- Organize and track the delivery of all project deliverables, ensuring high-quality output.
2. Quality Control
- Conduct thorough quality checks to ensure all deliverables meet high standards before distribution or client submission.
- Ensure documents are submission-ready, complying with regulatory guidelines, departmental SOPs, and client-specific style guidelines.
- Review draft and final documents prepared by other team members to ensure accuracy and compliance.
3. Document Project Management
- Serve as the primary contact for compilation and publishing projects, negotiating deliverable timelines and resolving project-related issues under departmental supervision.
- Represent the Document Specialist role on assigned projects, communicating requirements, conducting team reviews, and attending study team meetings to align on expectations and timelines.
- Distribute final documents to project teams and clients only after approval, adhering to Parexel or client guidelines.
- Organize and maintain project files and client documentation for easy access and reference.
Qualifications and Skills
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- Strong understanding of global regulatory submission formats, industry standards, and publishing best practices.
- Proficiency in MS Word and experience with document publishing software.
- Excellent attention to detail and organizational skills.
- Strong communication and collaboration abilities.
- Ability to work independently and as part of a team in a fast-paced environment.
Why Join Parexel?
At Parexel, we value alignment in our mission to improve global health. When our values align, there’s no limit to what we can achieve. By joining our team, you will:
- Contribute to the development of life-changing therapies.
- Work in a supportive and empathetic environment.
- Gain exposure to cutting-edge clinical development solutions.
- Be part of a global team committed to making a difference.
