BioSpace
BioSpace is hiring: Medical Writing Coordinator/Publisher III in North Chicago
BioSpace, North Chicago, IL, United States, 60086
Medical Writing Coordinator/Publisher III
Join to apply for the Medical Writing Coordinator/Publisher III role at BioSpace.
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 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.
- Experience: 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 & using 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 for clinical regulatory document preparation & submissions, organization & content of clinical documents, eCTD structure & CTD content templates.
- At least 1 year providing oversight & mentoring of assigned internal and external junior staff.
- Work experience may be gained concurrently.
- Hybrid (onsite 2 days a month / 18 days WFH / remote).
Additional Information
- Salary Range: $107,458 - $157,500 per year.
- Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF43610M.
- AbbVie is an equal opportunity employer.