Medical Writing Coordinator/Publisher III Job at AbbVie in Great Lakes

Document Publishing Specialist

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.

Key Responsibilities

Requires expertise in document publishing in eSubmission systems and publishing software.

• Compile, publish, verify, and quality-check various reports (e.g., CSRs, PCSs, ISS, ISE, PK & safety) to meet timelines and regulatory standards.
• Effective communication with medical writing and related teams, resolving issues, and adhering to deadlines.
• Assisting with implementation of publishing software updates, leading process improvements, managing schedules, mailbox, tracking metrics, maintenance of process documents/training materials, and training junior staff.
• Managing outsourced vendor work.

Qualifications

Must possess a Bachelor's in Science, English, or Communications, or foreign education equivalent, and 3 years of document publishing industry experience in clinical or regulatory document management.

Of experience required, must have at least 3 years of each of the following:

1. Applying report &/or submission publishing experience to clinical & regulatory documents.
2. Processing documents in a content management system & in utilizing the following publishing software: DocuBridge, ISI toolbox, & Adobe Pro DC.
3. Working in a matrixed organization across business stakeholders & managing workload scheduling.
4. Applying ICH E3 & 21 CFR 11 global regulatory requirements & guidance associated with clinical regulatory document preparation & submissions, organization & content of clinical documents, eCTD structure & Common Technical Document (CTD) content templates.

Of experience required, must have at least 1 year providing oversight & mentoring of assigned internal &/or external junior staff.

Work experience may be gained concurrently.

Hybrid (onsite 2 days a month/ 18 days WFH/remote)