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

AbbVie's Strategic Medical Writing team within the Specialty therapeutic area is dedicated to creating high-quality, evidence-based documents that support the development and communication of innovative therapies. We are recognized as leaders in medical writing, driving success through strategic insights and scientific excellence. We foster a collaborative environment which enables us to transform complex scientific data into clear, impactful narratives fulfilling AbbVie’s mission to deliver innovative medicines and solutions that address multifaceted health issues and enhance people's lives.

As a Principal Strategic Medical Writer at AbbVie, you will be responsible for leading and writing clinical and regulatory documents in support of company objectives. 

Your role responsibilities:

• Independently write most clinical and regulatory documents within remit. Coordinate the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents. Arrange and conducts review meetings with the team. Work closely with the team(s) on document authoring and content strategies.
• Communicate deliverables needed, writing process, and timelines to team members.
• Hold team members accountable to agreed-upon project dates. 
• Contribute to project management strategies and develops ability to lead team members, driving submission objectives.
• Recommend, leads, and/or participate in implementation/execution of tactical process improvements.  
• Develop expert knowledge of US and international regulations, requirements, and guidance associated w