Are you passionate about contributing to global healthcare advancements? Parexel, a leading clinical research organization, is hiring for the role of Document Specialist I. This is a remote position based in India (Bengaluru or Mumbai). If you have a keen eye for detail, expertise in document compilation and publishing, and a desire to make a difference in the pharmaceutical and clinical research industry, this opportunity is for you.
About Parexel
At Parexel, we are driven by a shared mission – to improve the world’s 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 team member, regardless of their role, contributes to the development of therapies that ultimately benefit patients worldwide. We take our work personally, approach it with empathy, and are dedicated to creating a meaningful impact.
Job Description: Document Specialist I
As a Document Specialist I, you will play a critical role in ensuring the accuracy, compliance, and timely delivery of clinical documents. Your responsibilities will include:
- Compilation and Publishing
- Compile appendices to clinical study reports in compliance with regulatory requirements.
- Collaborate with internal and external teams to ensure documentation is complete and adheres to guidelines.
- Utilize departmental publishing software to produce electronic deliverables with accurate navigability and hyperlinking.
- Format clinical documents in MS Word, insert tables, and coordinate the production and distribution of drafts and final documents.
- Quality Control
- Ensure all deliverables meet high-quality standards before distribution.
- Review draft and final documents prepared by other team members to ensure compliance with regulatory guidelines, SOPs, and style guidelines.
- Document Project Management
- Serve as the Document Specialist representative on assigned projects, communicating requirements and timelines to the team.
- Attend study team meetings to align on expectations and advance document publishing to approval.
- Organize and track the delivery of all project documentation.
- Training and Compliance
- Complete mandatory corporate, project-specific, and departmental training.
- Assist in training and mentoring new departmental staff as required.
- General Responsibilities
- Attend departmental and company meetings.
- Provide administrative support when requested.
Key Skills and Qualifications
- Strong understanding of global regulatory submission formats, industry standards, and publishing best practices.
- Proficiency in MS Word and document publishing software.
- Excellent attention to detail and organizational skills.
- Ability to work collaboratively in a team environment.
- Prior experience in clinical research or pharmaceutical documentation is a plus.
Why Join Parexel?
- Impactful Work:Â Contribute to the development of therapies that improve patient lives.
- Professional Growth:Â Access to training and mentorship opportunities.
- Remote Flexibility:Â Work from the comfort of your home in Bengaluru or Mumbai.
- Inclusive Culture:Â Be part of a team that values empathy, collaboration, and innovation.
How to Apply
