Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.
In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.
- Full Time
- Level: Mid
- Travel: No
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Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
- Detail-Oriented
- Deadline-Oriented
- Communicator
- Organized
- Versatile
- Tech-Savvy
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Work-life Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Career Development
Opportunity to learn and grow through a performance and development goal-setting program.
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Home based
Love where you work, and work where you love.
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Variety
Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.
Responsibilities
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
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