Assistant Director, Medical Writing

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.The Assistant Director of Medical Writing is responsible for the development, implementation, and maintenance of business systems within the Global Project Teams (GPT) that provide regulatory document support to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective management of the clinical writing process. Provides leadership in the overall regulatory document strategy for one or more therapeutic areas, working in collaboration with the Regulatory team. Provides expertise in project management of multiple compounds and/or projects. Manages the development and implementation of regulatory documents in support of overall regulatory strategies for multiple studies and/or compounds within one large or two or more small therapeutic areas. Interfaces with external groups (eg, PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions. Determines clinical writing resource needs for assigned therapeutic area(s) and manages both internal and outsourced personnel. The Assistant Director of Medical Writing is accountable for meeting the main objectives of the assigned therapeutic area(s) within established timelines and budgets, to the highest level of quality.Qualifications· 8 yrs relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support/R&D.· Minimum 3 yrs of project management experience, preferably with regulatory document project management and 3 or more yrs writing/editing and reviewing experience, preferably in the health care industry.· Minimum 5 yrs of management/supervisory experience including employee development.· Knowledge and experience with CTD content templates.· Expert knowledge of international regulations, requirements and guidance associated with document preparation and submissions.· Working knowledge of current electronic document management systems and information technology.· Proven track record of managing internal and external resources.· Track record of successful completion of significant projects using project management tools and processes. On time deliver of quality products.· Experience in human and financial resource management.· Collaborative teamwork and leadership track record. Excellent business communication skills with aptitude for summarization as well as detail orientation. Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.Abbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.