Associate Director, Medical Writing - Virtual
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.
Oversees the development, implementation, and maintenance of business systems that support clinical regulatory document creation, 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 document project management for multiple compounds and/or projects within one large or two or more small therapeutic areas. Interfaces with external groups 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. Accountable for meeting the main objectives of the assigned therapeutic area(s) within established timelines and budgets, to the highest level of quality.
- Supports scientific and marketing objectives for multiple compounds within one large or two or more small therapeutic areas in development through coordination, preparation, and approval of scientific documents.
- Provides managerial oversight of staff member(s) that support multiple compounds and/or indications of a major or complex product within assigned therapeutic area, including oversight of work products and activities.
- Provides oversight/project management of clinical writing projects for multiple compounds/indications within assigned therapeutic area(s) and regulatory submissions, within budget and timelines. Works with Project Teams to develop project objectives, strategies, timelines, and milestones. Effectively utilizes project management tools/techniques to drive multiple projects simultaneously.
- Develops expert knowledge of international regulations, requirements, and guidelines that apply to the preparation and production of submission-ready clinical documents. Implements established standards for business purposes and ensures they are consistently applied. Ensures department understands/complies with appropriate conventions, proper grammar and usage, and correct format requirements per ICH/other governing bodies by following established divisional guidelines, templates, and SOPs.
- Executes effective delegation, oversight and mentoring of permanent medical writers and contract writers working on projects for the therapeutic area(s) or multiple project teams. Assists in selection and supervision of freelance consultants or other vendors.
- Works directly with team members to develop/implement timelines to meet desired project completion dates. Coordinates activities and communications with functional areas such as Statistics, Regulatory, Submission Operations, Pharmacokinetics, Medical Directors, Safety Team on writing projects/submissions. Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge.
- 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.
- Builds cross-functional relationships and leads team meetings to address the specific projects and hold team members to the deliverables.
- 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).
- Determines resource needs within assigned therapeutic area(s) and manages associated budgets. Prioritizes resources to ensure efficient and timely completion of writing projects.
- Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.
- 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 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.
- 2-3 years of management/supervisory experience including employee development, or equivalent.
- Knowledge and experience with Common Technical Document (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. Collaborative teamwork and leadership track record.
- Track record of successful completion of significant projects using project management tools and processes. On time delivery of quality products.
- Experience in human and financial resource management.
- Excellent business communication skills with aptitude for summarization as well as detail orientation.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % 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.