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 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:
- applying report &/or submission publishing experience to clinical & regulatory documents;
- processing documents in a content management system & in utilizing the following publishing software: DocuBridge, ISI toolbox, & Adobe Pro DC;
- working in a matrixed organization across business stakeholders & managing workload scheduling; &
- 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)
Additional Information Salary Range: Salary Range: $107,458.00 - $157,500.00 per year.
Apply online at or send resume to Refer to Req ID: REF43610M
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
