Principal Strategic Medical Writer - Device

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

Purpose

Responsible for leading and writing clinical and regulatory device and drug documents in support of company objectives for the Aesthetics therapeutic area.

Responsibilities

In Aesthetics we support drug and device documents globally. The writing team participates in writing documents from study start-up to those that support product approvals (e.g. briefing books, IND, protocol, CSR, NDA sections, and regulatory response as well as CER, IDE and PMA).

Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents.

Arranges and conducts review meetings with the team.

Works closely with the team(s) on document authoring and content strategies.

Communicates deliverables needed, writing process, and timelines to team members.

Holds team members accountable to agreed-upon project dates. 

Contributes to project management strategies and develops ability to lead team members, driving submission objectives.

Recommends, leads, and/or participates in implementation/execution of tactical process improvements.  

Develops expert knowledge of global regulations, requirements, and guidance associated with preparation of regulatory documentation.

Qualifications

A minimum of 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, medical aesthetics, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.

Bachelor's Degree or higher in a scientific discipline.

Experience authoring device-specific documents preferred (e.g. CERs, SSCPs, IDEs, PMAs).

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