Senior Strategic Medical Writer - Remote

Role: Senior Strategic Medical Writer responsible for creating and managing clinical and regulatory documents supporting drug and device development at AbbVie. Objectives include ensuring high-quality, compliant submissions aligned with project timelines and regulatory standards. Responsibilities involve preparing documentation for global submissions, coordinating review processes, and maintaining compliance with US and international regulations. The role requires developing expertise in submission strategies, addressing review inquiries, and supporting process improvements. Qualifications: at least 4+ years in biopharmaceutical or healthcare industries, with a Bachelor's degree or higher in a scientific discipline; proven experience in clinical/regulatory writing, familiarity with ICH, GCP, and industry standards (e.g., CONSORT, PRISMA); strong communication and data analysis skills; understanding of drug development, clinical research, regulatory pathways, and medical terminology. Preferred skills include experience with EU and US device documentation. High-value details: involvement across multiple therapeutic areas, with a focus on pharma or biotech, supporting global regulatory submissions. Collaboration includes working with leadership, R&D, and Quality Assurance teams. The position involves continuous sitting, with no specific travel requirement stated, and may be remote or hybrid based on location.