About AbbVie 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. Since 2013, AbbVie has expanded its commitment to the San Francisco Bay Area with the consolidation of three Bay Area facilities to a new Bay Area headquarters in South San Francisco. AbbVie employees in the Bay Area drive AbbVie’s research-based, innovation driven missions in healthcare. Specifically, Bay Area employees bring deep scientific expertise and commercial excellence to advance cancer care. Current oncology areas of focus include immuno-oncology, tumor targeting, tumor dependency and precision medicine. With facilities positioned in the heart of the biotechnology industry, we are able to collaborate with the best and brightest minds in oncology. Responsible for developing and overseeing Medical Writing Operations including Medical Writing Coordinating/Report Publishing , Quality Control, and/or Word Processing & Standards) in support of the Oncology Early Development portfolio. This role includes the development and oversight of work products, business processes, and activities. Assist in the selection, management and oversight of vendor(s) and staff including approval of invoices within budgetary spend. May assist in developing team via coaching and mentoring. Develops, implements, and maintains standardized business process(es) and job aids in support of regulatory requirements for applicable documents. Responsible for ensuring the quality of clinical regulatory submission documents authored primarily by medical writing by conducting quality control review utilizing checklists as well as ensuring that the quality control review documentation is provided to the applicable master file(s) per the established business processes and procedures. Manages quality control work outsourced to vendor(s). Provides business process training to quality control vendors. Provides management and oversight/supervision for 1-2 contractors as delegated, including training. Key contributor in process and operational improvement activities. Responsibilities: Conduct and oversee Quality Control reviews to ensure high quality and accurate submission documents. Develop OED guidelines (standard operating procedures, work instructions, document processes) for Clinical Regulatory document consistency . Provide supervision and training of department employees, vendors, and contractors including oversight of budget/resources. Assist in the creation of document development processes for all clinical regulatory documents and manage this process within the department. Provide Quality Control oversight for data check against source files (eg, tables, figures, listings) to ensure that Clinical Regulatory documents are factually accurate and complete. Manage all editing of Clinical Regulatory documents for grammatical and formatting correctness, as well as ensuring clarity and compliance with internal guidelines (eg, Clinical Study Reports, Investigator’s Brochures, Clinical Summaries and Overviews, and other submission-related documents). Manage the development of OED document templates to maintain consistency across all documents. Ensure high quality of documents quality regarding content, organization, clarity, accuracy, format, style, and consistency. Independently manage and deliver multiple writing projects with minimal supervision within timelines. Develop and oversee Medical Writing Operations (MWOs) in support of OED portfolio, and global regulatory submissions, including the oversight of work products/activities. Assist in developing team via coaching and mentoring. Assist in scheduling work and managing resources/workload to meet timelines and quality standards, including the oversight of archival of documents processed in content management system(s). Effectively communicate to and among team members and across all levels of the organization. Develop and maintain strong collaborative relationships cross-functionally and globally. Maintain and manage QC schedule for clinical regulatory documents and hold team members accountable to the deliverables/timelines. Participate and is a key contributor in process and operational improvement activities. Form, lead, and maintain internal/external collaborative cross-functional process and operational improvement activities and initiatives/teams, including the application of change management. Monitor, complete, and report metrics to management as needed. Analyze metrics and recommend appropriate action (areas for improvement, trend identification, escalate areas of concern) Ensure consistent approach to real-time inspection readiness by providing leadership as SME for audits/inspections. Ensure maintenance of documentation by team in preparation and in support of audits/inspections. Assist in developing, implementing, and maintaining standardized business process(es) and job aids in support of regulatory requirements for the document support provided by MWOs to ensure accurate, timely completion, and delivery of high-quality submission-ready clinical regulatory documents. Assist in the selection, management and oversight of vendor(s) and staff for area and approval of invoices within budgetary spend Direct reports may include: medical writing coordinators and/or documentation specialists; or entry level quality control associates; or entry level medical writing document associates. Qualifications Qualifications: Bachelor's degree required. Bachelor's degree in Science, English or Communications preferred. 4-6 years relevant industry experience in medical writing or a related area such as clinical research, drug development, quality assurance/control, regulatory, report/submission publishing, or product support/R&D. Higher education may compensate for years of experience. Years of experience may also compensate for lower education. 1 year project management experience in MWOs (Medical Writing Coordinating/Report Publishing and Documentation Specialists, Quality Control, and/or R&S) or related area, including scheduling work and managing resources/workload (anticipated/unanticipated requests, time/resource management). Experience managing employees preferred or demonstration of successful coaching/mentoring in a matrix environment. Ability to assist in the selection, building, management, oversight, resource planning/allocation of functional resources, leadership, development, and direction for direct staff. Expert knowledge and application of global regulations, requirements and guidance associated with clinical regulatory document preparation and submissions and the ability to advise others regarding compliance with regulations and to apply towards the development and maintenance of business processes, job aids/tools, and training. Knowledge and expertise with Common Technical Document content templates. Extensive experience in working with collaborative, internal/external cross-functional teams building effective working relationships with a leadership track record across all levels of the organization. Excellent communication (oral, written, interpersonal, organizational), planning, execution, and team leadership skills. Superior attention to detail. Ability to influence current thinking and without direct authority. Developing strength in personal and technical leadership. Analytical/critical thinking and conflict management skills at operational and tactical levels. Competent in the application of Medical Writing Operations business processes. High degree of proficiency, skill, and knowledge in computer literacy (hardware and software)/technical skills (ability to apply towards process improvements/operational efficiencies/automation). 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). Proficient skills and knowledge in reference management software (e.g., EndNote). Self-motivated and highly organized with the ability to work remotely. Ability to manage multiple projects on tight timelines. Significant Work Activities N/A Travel No Job Type Experienced Schedule Full-time Job Level Code M 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.