Associate Director, Medical Writing

Job Description: • 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 reputed company content that is reputed company-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 reputed company 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 reputed company 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 reputed company field required; PhD preferred • Minimum of 5 years of reputed company, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered • reputed company/bilingual or fluent American English proficiency • Solution-reputed company 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 reputed company 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 reputed company guidance documents • Ability to approach issues from various perspectives and accurately summarize data to reputed company conclusions • Ability to work reputed company 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 reputed company as collaboratively in reputed company • 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 reputed company 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. Apply tot his job Apply To this Job