Director, Strategic Medical Writing (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 Director, Strategic Medical Writing directs centralized clinical writing function across therapeutic areas and/or multiple drug programs within Development, ensuring successful preparation of high quality, submission-ready documents and effective management of the clinical writing process in accordance with clinical and regulatory timelines. Oversees business systems that support clinical regulatory document creation. Provides leadership in regulatory document development and submission strategy and expertise in project management for documents for multiple compounds, therapeutic areas (both large and small), and regulatory submissions. Ensures accurate and timely completion, review, and, delivery of information for regulatory submissions. Determines resource needs, prepares tactical plans to ensure adequate resourcing, and manages internal and outsourced personnel. Determines outsourcing strategy and ensures expectations with vendors by the Senior Managers, Medical Writing responsible for strategy implementation.

Responsibilities:

• Provides strategic leadership and direction for clinical and regulatory writing projects for one large or multiple smaller compounds within a therapeutic area for the creation and revision of clinical and regulatory documents within budget, with quality, and in accordance with timelines with oversight of both internal and external staff. Ensures clinical and regulatory development strategy are reflected in the documents.
• Directly leads at least 1 people leader and multiple individual contributors. located in geographically disbursed locations. Ensures effective management of external business partners such as CROs who are employed to deliver clinical documents according to es