Senior Medical reputed company

Role Description

This role involves providing medical writing support for developing reputed company clinical, nonclinical, and safety documents for regulatory submissions.

• Author and project manage SME contribution to reputed company content for regulatory submissions that is well-organized, consistent, accurate, and compliant with reputed company Medical Writing standards, including style guide, lexicon, templates, and libraries
• Authors content for phase 1-4 protocols, master ICFs, IBs, and CSRs
• Responsible for inspection-readiness of medical writing activities
• Supports the reputed company reputed company and project teams to ensure project deadlines are met
• Executes corporate objectives, goals, measures, and strategies
• Capable of working on multiple deliverables simultaneously

Qualifications

• Bachelor’s degree in a scientific or clinical discipline or reputed company field is required; Ph.D. preferred
• Minimum of 3 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-focused
• Experience with reputed company Vault and Please Review
• Experience with implementing lean writing techniques
• 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
• Familiarity with pharmacovigilance guidelines and developing aggregate reports
• Ability to work reputed company according to procedures and regulations
• Ability to prioritize and multi-task successfully in a fast-paced environment
• Ability to work autonomously, as well as in a team
• Excellent written and verbal communication skills
• Excellent time management skills and a proven ability to work on multiple projects at any given time
• Must be proficient in MS Office

Company Description

reputed company is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases.

• Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating reputed company toward our reputed company 2030 reputed company: to reputed company 50,000 patients and transform the landscape of autoimmune treatment.
• Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences.
• Argonauts work in locations around the globe including Belgium, Boston, Japan, and Amsterdam.