Document Specialist I
India, Remote Additional Locations Mumbai,India Job ID R0000031065 Category Medical Writing Date Posted 02/19/2025Overview
As a Medical Writer at Parexel, your strong scientific knowledge, writing skills, and patient focus effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You must be able to collaborate within cross-functional teams to achieve the development of a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.
We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Consistent
- Deadline-oriented
- Detail-oriented
- Insightful
About This Role
Compilation and publishing
Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, with support of the project lead and lead medical writer. Work with internal or external Clinical and/or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines.
Understands global regulatory submission formats, industry standards, and guidelines, and publishing best practices
Use departmental publishing software to produce electronic deliverables to ensure insertion of navigability features, and accurate intra-document hyperlinking, according to SOP/client/regulatory requirements
Perform MS Word formatting of clinical documents according to SOP/client/regulatory requirements. Insert tables if requested. Coordinate production and distribution of draft and final documents to project team and client. Organize and track delivery of all deliverables.
Ensure that all work is complete and of high quality prior to delivery
Provide support on software and document related issues to MWS staff as required
Quality Control
Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
Ensure document is submission ready as per the appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable
Under appropriate supervision as needed, provide review of draft and final documents prepared by other DS before internal or external distribution
Document Project Management
Under departmental supervision, serve as contact for compilation and publishing projects, supports negotiating deliverable timelines, and resolving project-related issues.
Serve as the Document Specialist representative on assigned project, with departmental supervision:
communicate requirements, conduct team review of draft and final documents, attend study team meetings to agree on expectations, inform about the timeline, and advance document publishing to approval, according to Parexel or client guidelines/SOPs.
Distribute final documents to project team and client only if agreed.
Perform collection of documentation for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator.
Project management of contractual and financial aspects may only be performed with the guidance of medical writing management
Training/ Compliance
Attend and complete mandatory, corporate, project-specific, and departmental training as required.
Assist in the training/mentoring of new departmental staff as required.
General
Attend departmental and company meetings as necessary. Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform.
Provide administrative support if requested.
#LI-REMOTE
Potential Career Path
Parexel offers career paths for Medical Writers to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Associate Medical Writer
- Medical Writer I
- Medical Writer II
- Senior Medical Writer
- Subject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
WHY MEDICAL WRITERS WORK AT PAREXEL
