Medical Writing Coordinator/Publisher III

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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Key Responsibilities

• Requires expertise in document publishing in eSubmission systems & publishing software.
• Tasks include compile, publish, verify, & quality-check various reports (e.g., CSRs, PCSs, ISS, ISE, PK & safety) to meet timelines & regulatory standards.
• Key responsibilities involve effective communication with medical writing & related teams, resolving issues, & adhering to deadlines.
• Support involves assisting with implementation of publishing software updates, leading process improvements, managing schedules, mailbox, tracking metrics, maintenance of process documents/ training materials, & training junior staff.
• Also responsible for managing outsourced vendor work.

Qualifications

Education & Experience

Must possess a Bachelors in Science, English, or Communications, or foreign education  equivalent, & 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 te