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
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.
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