Principal Strategic Medical Writer (Remote)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Principal Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents that support the company's objectives.

Responsibilities
The Principal Strategic Medical Writer independently writes most clinical and regulatory documents within their remit. They coordinate the review, approval, and quality control processes involving other functions in the production of clinical and regulatory documents. They arrange and conduct review meetings with the team to ensure thorough examination of content. The writer works closely with teams on document authoring and content strategies to ensure alignment with project goals.
The writer communicates deliverables needed, the writing process, and timelines to team members, ensuring clarity and understanding of expectations. They hold team members accountable to agreed-upon project dates, contributing to the success of timely submissions.
The writer contributes to project management strategies and develops the ability to lead team members, driving toward submission objectives. They recommend, lead, and participate in the implementation and execution of tactical process improvements to enhance efficiency and effectiveness.
The writer develops expert knowledge of US and international regulations, requirements, and guidance associated with the preparation of regulatory documentation. They identify and propose solutions to resolve issues and questions that arise during the writing process, including resolution or escalation as appropriate.
The writer learns and applies therapeutic area and product knowledge to scientific projects and business improvement initiatives. They work independently with R&D Quality Assuranc