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Regulatory Medical Writing Director
2 months ago
We are seeking an experienced Associate Director of Regulatory Medical Writing to join our team at Argenx. As a key member of our medical writing department, you will be responsible for developing complex clinical, nonclinical, and safety documents for regulatory submissions.
Key Responsibilities- Leadership and Management
- Manage a team of medical writers to ensure timely and high-quality delivery of regulatory documents.
- Develop and implement processes to improve efficiency and productivity within the medical writing department.
- Document Development
- Author clinical content and project manage SME contribution of regulatory documents to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with applicable company SOPs, style guide, lexicon, templates, and libraries.
- Collaborate with clinical project teams, including program leaders, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are met.
- Regulatory Compliance
- Ensure that all regulatory documents are compliant with FDA and ICH guidelines for clinical reporting.
- Responsible for inspection-readiness of medical writing activities.
- Strategic Planning
- Develop and implement strategies to improve the quality and efficiency of medical writing processes.
- Collaborate with cross-functional teams to ensure alignment with corporate objectives and goals.
- 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.
