AbbVie Manager of Medical Writing Word Processing & Standards in Lake County, Illinois
Manager of Medical Writing Word Processing & Standards
USA, Illinois, Lake County
1 additional location
Research & Development
Overall accountability for providing leadership and direction, implementing the development and maintenance of standardized training materials/tools, and, the development of the Word Processing personnel.
Overall accountability for scheduling work and managing workload for the Word Processing personnel.
Supports/acts as back up to Senior Manager, Medical Writing Word Processing & Standards, who 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.
Supports/acts as back up to Senior Manager, Medical Writing Word Processing & Standards, who 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.
Supports/acts as back up to Senior Manager, Medical Writing Word Processing & Standards, 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.
Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or Communications, with relevant science experience.
6+ 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 preferred.
Experience in scheduling work and managing workload (anticipated/unanticipated requests, time/resource management). Experience implementing the development and/or maintenance of standardized training tools/materials, and the development of personnel.
Experience in developing/instituting standard procedures, guidelines, and templates. Knowledge and experience with CTD content templates. 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.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Job Type: Experienced