Medical Writing Coordinator/Publisher III
Medical Writing Coordinator/Publisher III
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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: $107458.00 - $157500.00 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 AbbVies 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:
No
Employment Type :
Full-time
Employment Type
Full-time
