Job Description

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Company Description

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to provide innovation, education, exceptional service, and a personal touch. For more information, visit . Follow Allergan Aesthetics on LinkedIn.

Job Description

Purpose

The medical writer provides clinical regulatory document support to clinical teams, ensuring high-quality, submission-ready documents, and effective process implementation. They offer medical writing expertise across multiple compounds or projects within or across therapeutic areas, collaborating with external groups to ensure accurate and timely completion of regulatory submissions and participating in process improvements.

Responsibilities

1. Assist with or implement activities related to data compilation for regulatory documents, understanding and interpreting sources with guidance. Capable of writing less complex documents such as protocols independently, with supervision on complex types.
2. Communicate deliverables, timelines, and processes effectively to team members, holding them accountable for project deadlines.
3. Identify and propose solutions to issues during the writing process, escalating as necessary.
4. Follow conventions, grammar, and format requirements per ICH and other guidelines, adhering to divisional standards.
5. Conduct review meetings, resolve issues, and collaborate with managers during audits and responses.
6. Produce and maintain clinical documents focusing on quality and compliance, ensuring timely delivery.
7. Maintain familiarity with US and international regulations related to scientific publications and clinical documents.

Qualifications

• At least 2+ years of bio-pharmaceutical industry experience across therapeutic areas.
• Bachelors Degree or higher in a scientific discipline.
• Excellent written and oral communication skills, with knowledge of medical/scientific terminology.
• Proficient in analyzing complex data and writing/editing clinical documents following guidelines such as ICH, GCP, and industry standards like CONSORT and PRISMA.
• Deep understanding of drug development, clinical research, study designs, biostatistics, pharmacology, and regulatory requirements.
• Strong organizational and problem-solving skills with the ability to manage multiple projects and collaborate effectively.

Additional Information

Details about pay ranges, benefits, and legal disclosures are included, emphasizing the company's commitment to equal opportunity employment and accommodations for applicants.

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