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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Clinical Technical Editor (FSP)

Job ID 69931BR USA - Any Region - Home Based
About ExecuPharm
ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Position Purpose:
The Clinical Technical Editor is responsible for the quality control, formatting, technical editing, and tool support for the clinical regulatory writing portfolio composed of multiple therapeutic areas. The candidate will work within the client environment using client’s tools, systems, guidelines, checklists, and processes.
Organizational Relationships:
• Reports to ExecuPharm (EP) assigned Line Management with day-to-day direction from Client
• Liaises with cross-functional lines as appropriate
Primary Duties:
• Coordinate and perform quality control (QC) of clinical documents to ensure data consistency and document integrity, consistency of text with internal document data displays as well as external reference sources
• Ensure documents comply with appropriate International Council on Harmonisation (ICH) standards, regulatory guidance, and company templates and processes
• Ensure consistent QC and good document practices are followed to ensure readiness for downstream stakeholders (eg, publishing teams)
• Proofread, review, edit, and confirm data against sources to verify:
o Completeness and accuracy of information
o Accurate use of grammar and style
o Application of format standards for electronic documents
o Compliance with submission ready standards
• Work within appropriate document management systems to ensure security and version control is maintained
• Support the development, implementation, and periodic review of editorial management procedures
• Support tool enhancements, testing, and maintenance as applicable
• Support tools and processes for implementation of structured content management
• Work collaboratively with medical writers, regulatory publishers, and project team members to deliver high-quality clinical documentation in a timely manner
• Support medical writers on the use of tools, technologies, and company templates to facilitate efficient and compliant document delivery
• Ensure compliance with company training and time reporting
• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process-related training
• Adhere to EP and Client SOPs and processes

Qualifications

Skills and Education:
• Bachelor’s degree (English, Life Sciences)
• Minimum 2 years in editing and QC of scientific/clinical documentation in a pharmaceutical, biotech, clinical research, or related environment
• Complete fluency in reading and writing American English
• Understanding of appropriate ICH and regulatory guidance pertaining to clinical documents
Understanding of Study Data Tabulation Model (SDTM) data structures for purposes of navigating the data to reconcile data back to source
• Ability to perform QC for clinical documentation that includes, but is not limited to, clinical protocols, investigator brochures, informed consent forms, clinical study reports (including administrative appendices), patient narratives, and clinical modules of the common technical document in multiple therapeutic areas
• Advanced Word and Adobe Acrobat skills
• Experience working in Excel workbooks; macro writing capabilities preferred
• Experience working in document management systems; capable of managing workflows and troubleshooting user errors
• Experience with collaborative authoring and review tools
• Flexibility in adapting to new tools and technology
• Writing and editing skills following defined processes and templates
• Good communication skills (email responses, meeting presentations)
• Effective time management, organizational, and interpersonal skills
• Customer focused
• Ability to work independently in a fast-paced environment

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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