Medical Writing Document Associate III (Lake County, IL or Remote)
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
End-to-end word processing resulting in high-quality eSubmission-ready documents across all therapeutic areas and/or multiple drug programs globally in accordance with clinical and regulatory timelines. Self-assignment/independent management of work requests. Coaching, mentoring, training, and qualifying more junior staff. Acts as Word Processing & Standards (WP&S) clinical business subject matter expert (SME) for medical writers and others for clinical regulatory templates and eSubmission system in support for the increased importance/focus on audit/inspection readiness/requests. Participates and is a key contributor in process and operational improvement activities. Assists in the management and oversight of the Clinical Word Processing (CWP) and WP&S mailboxes by responding to client requests. Assist management in tracking and maintaining metrics. Assist management in the preparation and maintenance of internal business process documents and training materials.
1. End-to-end word processing (formatting/proofing of MS Word and pdf documents of increasing complexity, importing/creating pdfs with correct document properties/naming conventions and initiation/termination of workflows in eSubmission content management system as well as communication of the status of workflows to multiple functional area clients) resulting in timely high-quality eSubmission-ready documents across all therapeutic areas and/or multiple drug programs globally.
2. Self-assignment/independent management of work requests for end-to-end word processing for documents trained on and qualified to complete. Ability to carry larger and more complex workload then more junior staff. Coaching, mentoring, training, and qualifying more junior staff on documents qualified to complete end-to-end word processing. Holds self and team members accountable to agreed-upon deliverables and dates. Update/maintain document practice libraries for more junior staff.
3. Communicate regularly and effectively with colleagues and management regarding timelines and conflicts to timelines for requests, eSubmission issues and document completion dates. Ensure all electronic document deliverables are processed and completed in alignment with timelines and an appropriate level of accuracy.
4. Ensure document format and style are consistent with defined eSubmissions format and styles, such that documents created in MS Word correctly render to pdf. Confirm formats and styles are consistent with those in the clinical regulatory templates, when applicable. Maintain strong knowledge of eSubmission styles and formatting standards. Must be compliant with all current industry requirements as they relate to regulatory submission, including electronic submission/approval standards.
5. Proofread documents for accuracy and consistency. Import and route documents in the eSubmission system ensuring proper document properties and correct naming conventions are used per the eSubmission system file naming conventions.
6. Accurately and timely maintain document tracking for all documents. Ensure literature citations are correct. Perform literature searches.
7. Acts as WP&S clinical business subject matter expert for medical writers and others for clinical regulatory templates and eSubmission system in support for the increased importance/focus on audit/inspection readiness/requests.
8. Participates and is a key contributor in process and operational improvement activities (e.g., eSubmission content management systems, bot for automation of WP&S tasks).
9. Assists in the management and oversight of the Clinical Word Processing (CWP) and WP&S mailboxes by responding to client requests.
10. Assist management in tracking and maintaining metrics associated with WP&S. Assist management in the preparation and maintenance of internal business process documents and training materials related to WP&S and deliverables.
1. High school diploma required. Bachelor's degree in Science, English or Communications preferred.
2. 2-3 years relevant industry experience as MW document specialist with demonstrated higher degree of proficiency, skill, and knowledge in end-to-end word processing then more junior levels or related experience.
Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
3. Excellent knowledge of organization and content of clinical documents and eCTD structure.
4. Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
5. Working knowledge of global regulatory requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Competent/expertise in the application of business processes (guidelines, standard operating procedures, work instructions, job aids, etc.).
6. Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs.
7. Excellent oral/written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills. Superior attention to detail and ability to prioritize multiple tasks/projects. Operates with limited oversight. Proven analytical and critical thinking skills.
8. Experience in working with collaborative cross-functional teams.
9. Demonstrated higher degree of proficiency, skill, and knowledge then more junior levels -- Computer literacy (hardware and software)/technical skills (ability to apply towards process improvements/operational efficiencies/automation).
10. Proficient skills and knowledge in Microsoft Office Products (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe in Windows operating system environment required. Proficient skills and knowledge in Microsoft document file formats (DocX) or other style file format tools, publishing software, and content management archival system(s) for eTMF/eSubmissions (Veeva Vault, CARA).
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.