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Job Description
Purpose:
The Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically aligned clinical and regulatory documentation that supports AbbVie's mission to transform the standard of care. Our team serves as a critical link between research, development, and regulatory submissions, ensuring clarity and compliance in all clinical and regulatory documents. We strive to innovate and enhance the processes of medical writing through cross-functional collaboration, agile methodologies, and the integration of cutting-edge technology, driving forward AbbVie's commitment to improving patient outcomes worldwide.
Responsibilities:
- Defines scope of quality control activities with the document author and the required source documents and data required. Conducts independent quality control review of documents per applicable checklist by checking against source documents to ensure results are accurate.
- Ensures quality control documentation is complete and accurate and uploaded to the master file per the established business processes.
- Maintain strong knowledge of clinical regulatory documents requiring quality control review and business processes.
- Mentors and provides guidance and training to less senior medical writing operations staff members. Provides management and oversight/supervision of 2 or more contractors as delegated.
- Leads the development, implementation, and maintenance of medical writing operations business processes. Acts as subject matter expert (SME) for the master file system and quality control to the medical writing stakeholders.
- Manages quality control outsourced to vendors that includes providing training and the preparation of the required documentation (e.g. clinical documents, checklists) for the quality control.
- Effectively communicates quality control deliverables needed to stakeholders. Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.
- Bachelor’s degree required. Bachelor’s degree in Science, English, or Communication preferred.
- 3-4 years in relevant industry experience in quality control/review of clinical regulatory documents or related experience in an area such as quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
- Project management experience is preferred.
- Excellent knowledge of organization and content of clinical documents and eCTD structure. Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
- 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).
- Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs. Operations with limited oversight. Proven analytical and critical thinking skills.
- Demonstrate higher degree of oral/written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills. Superior attention to detail and ability to prioritize multiple tasks/projects.
- Experience in working with collaborative cross functional teams.
- Demonstrate higher degree of proficiency, skill, and knowledge then more junior level. Computer literacy (hardware and software)/technical skills (ability to apply towards process improvements/operational efficiencies/automation).
- Proficient skill 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).
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- 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 incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
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