ELA Content Writer – Assessment Focus
Teachers Pay Teachers
Associate Director, Medical Writing – CRO Oversight
argenx
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud PlatformVault
About the role
- Serve as the primary point of contact for CRO medical writing teams and ensure alignment with company standards, timelines, and expectations
- Onboard and train CRO medical writers as needed
- Provide document-level guidance, review, and final approval oversight for CRO-authorized deliverables (eg, protocols, protocol amendments, clinical study reports, informed consent forms)
- Ensure consistent scientific messaging and adherence to company lexicon, style guides, and quality standards across outsourced deliverables
- Monitor CRO performance metrics (quality, timeliness, compliance), and participate in governance meetings, if applicable
- Identify training or quality improvement needs for vendor teams and coordinate targeted upskilling or remediation
- Develop and maintain medical writing governance frameworks for outsourced deliverables, including SOPs, templates, and quality control/clinical editing processes
- Ensure alignment of outsourced documents with internal data strategy, key messages, and regulatory objectives
- Partner with cross-functional teams to ensure outsource writers have appropriate context and access to subject matter experts
- Contribute to vendor selection and evaluation processes, including defining medical writing requirements and KPIs
- Ensure quality review and continuous improvement initiatives within the medical writing outsource model
- Support internal writers and reviewers in effectively collaborating with CRO partners
- Participate in defining and refining the outsourced MW model
- Represent MW in vendor governance/operational review forums
- Engage relevant SMEs and document owners to directly author content that is well-organized, consistent, accurate, and appropriate for a regulatory audience
- Responsible for the inspection-readiness of medical writing activities
- Facilitate standardization of documents using document templates, lexicons, and the argenx style guide to ensure the quality and consistency of documents across programs
- Responsible for medical writers assigned to support the medical writing activities for a particular project
- Executes corporate objectives, goals, measures, and strategies and begins to inform the development of them
- Capable of working on multiple deliverables simultaneously
Requirements
- PhD or advanced degree in a scientific or clinical discipline or related field required
- Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required
- CRO experience required
- Strong organizational, communication, and influencing skills
- Fluent American English proficiency
- Excellent written and verbal communication skills
- Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
- Solid understanding of ICH, GCP, and global regulatory submission requirements (FDA, EMA, PMDA, etc)
- Ability to proofread documents for compliance with internal and external guidance documents
- Excellent attention to detail and ability to maintain a strategic perspective under tight timelines
- Ability to establish and maintain productive cross-functional and vendor relationships
- Ability to approach issues from various perspectives and accurately summarize data to provide conclusions; solution-focused
- Ability to work precisely according to procedures and regulations
- Ability to prioritize and multitask successfully in a fast-paced environment
- Ability to work autonomously, as well as collaboratively in a team
- Excellent time management skills and a proven ability to work on multiple projects at any given time
- Must be proficient in MS Office
- Proficiency in document management and collaborative authoring platforms (Veeva Vault, Please Review preferred)
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical study reportsprotocol designregulatory submissionproofreadingquality controlscientific methodologydocument templatesclinical editingCRO management
Soft skills
organizational skillscommunication skillsinfluencing skillsattention to detailtime managementcollaborative skillsproblem-solvingmultitaskingstrategic perspectiverelationship management
Certifications
PhDadvanced degree in scientific discipline
