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.
The Director of Regulatory Strategic Writing (RSW) is responsible for leading a writing team corresponding to a Therapeutic Area (TA), (eg, Oncology) in support of regulatory submissions to health authorities. In partnership with the Global Regulatory Product Team (GRPT), the RSW Director and team prepare submission documents comprised of strategic, high-quality scientific justification of company positions and relevant knowledge. The Director supports business systems that provide for the preparation, approval and submission of regulatory response documents. In addition, the Director provides leadership in submission strategy and expertise in project management and ensures accurate and timely completion, review and delivery of materials. The Director determines resource needs and develops tactical plans to execute outsourcing strategy and manage expectations with vendors and internal staff. The Director of RSW reports to the Senior Director of RSW or higher.
- Executes effective delegation, oversight, and mentoring of personnel for preparing documents for TA programs. Develops standards for working with vendors that ensure effective management and collaboration. Supports scientific and marketing objectives for assigned TA through initiation of a program, coordination of RSW staff and functional area contributors, document preparation, and approval.
- Demonstrates expertise in management of RSW processes for regulatory submissions and executes successfully against regulatory timelines. Effectively utilizes project management tools/techniques to drive multiple projects simultaneously.
- Determines TA resource needs and manages resources effectively against associated budgets. Directly leads personnel located in geographically dispersed locations. Assists in selection and supervision of contractors, vendor personnel and freelance consultants.
- 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. Designs and implements systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality.
- Serves on cross-functional task forces representing TAs 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.
- Responsible for talent management oversight and performance reviews for full time employees within the assigned TA. Supervises training and ensures assignments are completed in a timely manner.
- Authors and maintains RSW document processes (eg, SOPs, work practices, job aides, templates and other supportive documentation, etc.) as needed, to align with department and organizational goals, to stay compliant with corporate guidelines, and to leverage current IT platforms efficiently.
- Communicates progress and track required deliverables and timelines/milestones to senior leadership in RSW. Maintains the RSW Book of Work and forecast overall global project/departmental workload for assigned TA.
- Recognizes potential scheduling and resource conflicts for projects 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.
- A Bachelor’s degree is required. A relevant advanced degree (e.g. MS, Pharm D, PhD, MD) is preferred, and higher education may compensate for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
- Minimum of 6 years of relevant industry experience required in medical/regulatory writing in the healthcare industry or academia or in a related area such as quality, clinical research, or product support or research and development.
- Minimum of 4+ years of project coordination experience, preferably with regulatory document project management and 3+ years of supervisory experience including employee development and management of external resources, and development and motivation of direct reports and addressing performance issues.
- Demonstrated experience in collaborating cross functionally; needs little guidance on forging strategy and executing on that strategy. Able to increase the level of skill of team over time. Strong written and verbal communication skills, including strong negotiation skills. Comfortable with challenging status quo and making recommendations to GRPT to advance program objectives and achieve best possible solutions.
- Advanced skill in leadership, team development, and multitasking across multiple programs. Proficient with management of internal and external resources (both local and remote). Advanced skill in resource management and problem-solving skills in both strategic and operational capacities. Must be comfortable with issue resolution and managing through ambiguity. Possesses strong discernment skills with respect to issue resolution and potential need for issue elevation.
- Experience in Regulatory Affairs either via industry or education; knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Experience writing regulatory documents in multiple therapeutic areas and ability to assimilate and interpret and translate information for appropriate audience.
- Excellent working knowledge of current electronic document management systems and information technology; knowledge and experience with Common Technical Document content templates. Excellent working knowledge of software programs in a Windows environment.
- RA management
- Global Regulatory Product Team members and their associated Regulatory Leads
- R&D functional management and subject matter experts involved in generating regulatory documents
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.