Director, Medical Writing
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.
Directs centralized clinical writing function across therapeutic areas and/or multiple drug programs within Development, ensuring successful preparation of high quality, submission-ready documents and effective management of the clinical writing process in accordance with clinical and regulatory timelines. Oversees business systems that support clinical regulatory document creation. Provides leadership in regulatory document development and submission strategy and expertise in project management for documents for multiple compounds, therapeutic areas (both large and small), and regulatory submissions. Ensures accurate and timely completion, review, and, delivery of information for regulatory submissions. Determines resource needs, prepares tactical plans to ensure adequate resourcing, and manages internal and outsourced personnel. Determines outsourcing strategy and ensures expectations with vendors by the Senior Managers, Medical Writing responsible for strategy implementation.
•Executes effective delegation, oversight, and mentoring of personnel for documents for multiple compounds, therapeutic areas (both large and small), and regulatory submissions including developing standards for working with vendors that ensure effective management of vendors. Supports scientific and marketing objectives for multiple compounds within multiple large and small therapeutic areas in development through coordination, preparation, and approval of scientific documents.
•Demonstrates expertise in management of clinical writing and clinical writing processes for multiple compounds, therapeutic areas (both large and small), and regulatory submissions executing successfully against regulatory timelines. Effectively utilizes project management tools/techniques to drive multiple projects; responsible for overall project management for several projects simultaneously.
•Determines resource needs within assigned therapeutic area(s) and manages associated budgets. Prioritizes both internal and external resources to ensure efficient and timely completion of writing projects.
•Directly leads personnel located in geographically dispersed locations. Assists in selection and supervision of freelance consultants or other vendors.
•Executes effective delegation, oversight, and mentoring of personnel including contract writers for documents for multiple compounds, therapeutic areas (both large and small), and regulatory submissions including developing standards for working with vendors that ensure effective management of vendors.
•Works with cross-functional project teams to develop project objectives, strategies, corresponding timelines, and milestones. Coordinates activities and communications with cross-functional areas on writing projects/submissions utilizing cross-functional skills/expertise and drug development knowledge. Builds cross-functional relationships/leads team meetings to address specific projects and hold team members to the project tasks/deliverables.
•Develops and applies expert knowledge of international regulations, requirements, and guidelines that apply to the preparation and production of submission-ready clinical documents. Implements established standards, as appropriate to ensure they are understood and consistently applied. Includes appropriate conventions, proper grammar and usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs.
•Designs and implements systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality.
•Serves on cross-functional task forces representing therapeutic area(s) for development of clinical writing best practices and other initiatives. Works closely with manager to identify and implement measures and activities to grow the business and expand the department’s influence and visibility within the company.
•Collects appropriate metrics for assigned therapeutic area(s), as established by the Medical Writing organization that ensures a high level of internal writing performance as well as adherence to pharmaceutical industry standards (i.e. speed, volume, quality, complexity).
•Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.
•Minimum 5-10 years relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support/Research & Development (R&D).
•Minimum 3-5 years of project management experience, preferably with regulatory document project management and 3 or more years writing/editing and reviewing experience, preferably in the healthcare industry.
•Minimum 3-5 years of management/supervisory experience including employee development and management of external resources, including developing and motivating direct reports and addressing performance issues.
•Knowledge and experience with Common Technical Document (CTD) content templates including regulatory submission experience. Expert knowledge of international regulations, requirements, guidance, and effective processes associated with document preparation and submissions, including proven ability to create strategic, division-wide documents and writing plans. Working knowledge of current electronic document management systems and information technology.
•Demonstrated abilities in leadership and teamwork capacities managing projects for multiple compounds, therapeutic areas (both large and small), and regulatory submissions using both internal (multidisciplinary) and external resources, many of which are geographically dispersed, using project management tools and processes for on time delivery of quality products.
•Experience in financial resource management.
•Requires problem solving abilities at both strategic and operation levels. Must be comfortable operating within “gray,” with a high tolerance for ambiguity, reaching decisions with limited information. Must exercise strong judgment in distinguishing issues needing elevation, as well as the level to which an issue should be elevated. Challenges and make recommendations to the GPT to achieve best possible timeline and resource utilization.
•Recognizes potential scheduling and resource conflicts for project and provides recommendations to resolve. Identifies issues impacting team alignment and implements resolutions to resolve team discord. Identifies and anticipates potential department problems impacting ability to meet business goals, develops and implements methods of improvement and resolution.
•Actively participates in process improvement initiatives, both within the department and division-wide.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
Job Level Code
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.