Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug development
Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience
Responsible for inspection-readiness of medical writing activities
Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs
Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
Collaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are met
Responsible for inspection-readiness of medical writing activities
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

Bachelor’s degree in a scientific or clinical discipline or related field required; PhD preferred
Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
Native/bilingual or fluent American English proficiency
Solution-focused eCTD Module 5 and Module 2 writing experience for global MAAs
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
Knowledgeable in the regulatory guidance developed for documents authored by medical writing
Ability to proofread documents for compliance with internal and external guidance documents
Ability to approach issues from various perspectives and accurately summarize data to provide conclusions
Ability to work precisely according to procedures and regulations
Excellent written and verbal communication skills
Ability to prioritize and multi-task 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
Familiarity with Veeva Vault and Please Review preferred
Familiarity with pharmacovigilance documents preferred

Benefits

Comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

medical writingeCTD Module 2eCTD Module 5regulatory documentsscientific methodologyprotocol designclinical developmentproofreadingdrug developmentpharmacovigilance

Soft Skills

excellent written communicationexcellent verbal communicationtime managementmulti-taskingautonomous workcollaborative worksolution-focusedability to prioritizeattention to detailability to summarize data

Certifications

Bachelor’s degreePhD