TMF Document Specialist - FSP
Primary Location: Argentina, Remote Job ID R0000034683 Category Medical Writing Date Posted 07/25/2025Overview
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
Parexel FSP is seeking a TMF Document Specialist in Argentina!
Job Summary
The TMF Document Specialist is responsible for ensuring the quality of documents in the TMF system. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of document issues with Document Owners/TMF Study Owners or other end users.
Job Responsibilities
Process TMF documents received per good documentation practices, TMF readiness criteria and other reference documents
Demonstrate understanding of document types, properties and indexing requirements
Ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy
Process documents in the TMF system(s) within specified timelines, based on document criticality/priority
Communicate document inquiries with responsible users as needed
Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues
Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations when needed
Contribute to process improvement initiatives and projects that may arise
Can be identified as Subject Matter Expert for TMF process, systems and related tools, where applicable
Qualifications
Education
Minimum of a Bachelor’s degree or equivalent.
Prior Experience Preferred
Hands-on experience with electronic documentation management systems and/or web based data management systems
Records management experience in a highly regulated environment (preferably clinical research) or experience working with clinical/medical records
Experience/knowledge of ICH/GCP documentation requirements
History of achievement in a customer service role with demonstration of meeting customer needs and concerns
#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
