Senior Manager, Word Processing and Standards

Primary responsibility (potentially shared responsibility with current Senior Manager of Word Processing & Standards) for the management and oversight of Word Processing personnel (11 non-exempt direct reports and contractors), including: providing leadership and direction; implementing the development and maintenance of standardized training materials/tools; the development of personnel; and, scheduling work and managing workload for the Word Processing personnel. Shared responsibility with other Senior Manager of Word Processing & Standards for implementing the development and maintenance of global clinical standards (including business processes, new systems, standards, templates, related initiatives) related to the submission process in support of the production of high quality, submission-ready documents .

• Executes the creation and maintenance of global clinical standards related to the submissions process.
• Identifies and implements new procedures needed as the Medical Writing organization evolves with an overall emphasis on a quality system that supports the clinical regulatory writing process and the production of submission-ready documents.
• Owns overall accountability for document template creation, maintenance, and, management. Ensures clinical regulatory content templates are comprehensive, cohesive, understandable, and compliant to support submission ready documents. Establishes, monitors, and maintains medical writing standards as represented in the Electronic Submissions Style Guide.
• As part of broader R&D implementation effort, manages the associated transition to eCTD and other future initiatives which will require significant document and process changes; subsequently, works to operationalize these changes.
• Contributes as member of broader R&D team, under the leadership of regulatory, to stay current on regulations affecting submission ready documents and drive necessary changes to reflect expectations on clinical regulatory documents. Anticipates issues and recommends best practices appropriate for resolution.
• Manages the clinical standards and document migration required by upgraded eSubmissions interfaces and involving file names, folder structure, properties, and content template processes.
• Performs gap and impact analyses, based on changes to internal and external requirements, to ensure standards compliance to internal and external requirements as both continue to evolve.
• Acts as single point of contact for Regulatory Submission Operations in the development and management of standards that are focused on clinical regulatory documents. Ensures standards are in place for clinical regulatory documents with external business partners such as CROs. Communicates global clinical regulatory document standards, and interacts accordingly with all AbbVie constituents.
• Applies practical experience and knowledge in process improvement and change leadership related to clinical regulatory documents. Participates in, and may lead elements of, business process design to improve efficiency and compliance with ever-changing regulations.
• Assists the Manager of Medical Writing Word Processing & Standards in the management oversight for Word Processing personnel .

• Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or Communications, with relevant science experience.
• 8+ years relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support/R&D. NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
• Experience managing employees required.
• Experience in scheduling work and managing workload (anticipated/unanticipated requests, time/resource management). Experience implementing the development and/or maintenance of standardized training materials/tools, and the development of personnel.
• Experience in developing/instituting standard procedures, guidelines, and templates. Expert level of knowledge and experience with CTD content templates. Thorough understanding/working knowledge of MS Word.
• Assessment, completion, and, reporting of metrics to management on a routine basis.
• Knowledge of international regulations, requirements and guidance associated with document preparation and submissions.
• Knowledge of current electronic document management systems and information technology.
• Developing strength in technical leadership and personal leadership; ability to influence current thinking.
• Collaborative teamwork and leadership track record. Excellent business communication/presentation skills with aptitude for summarization as well as detail orientation. Ability to influence without direct authority. Ability to build and maintain positive relationships internally and externally .