Associate Director - Regulatory Medical Writing

September 17

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argenx

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Oncology • Autoimmune diseases • Rare Diseases • Antibody based medicines • Immunotherapy

1001 - 5000

Description

• Manage medical writers (in-house FTEs and contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents • Author clinical content and project manage SME contribution of regulatory documents to develop content for regulatory submissions that is well-organized, consistent, accurate, and that complies with applicable company SOPs, style guide, lexicon, templates, and libraries • May include roles that are key technical or subject matter experts providing professional or thought leadership • Looks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to the achievement of objectives • Collaborates with clinical project teams, including program leader, clinical study managers, biostatisticians, 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 • Establishes operational objectives, policies, procedures, and job aids • Executes corporate objectives, goals, measures, and strategies; and begins to inform the development of them • May delegate work assessments

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 • Familiarity with FDA and ICH guidelines for clinical reporting • Familiarity with pharmacovigilance documents preferred • eCTD development, publishing, and submission experience preferred • Therapeutic experience in biologics preferred • Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission • Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs) • 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