United Therapeutics Director, Regulatory Promotion and Advertising in Durham, North Carolina
The Job Details are as follows:
Lead, conduct, and develop and implement procedures and strategies to facilitate regulatory affairs activities for review and approval of promotional activities and marketing materials for all United Therapeutics products.
Key Accountabilities / Responsibilities
Direct and conduct regulatory reviews and approvals of promotional materials and marketing activities
Ensure on-time and accurate submission of promotional materials to regulatory agencies
Serve as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion of prescription drugs
Provide regulatory leadership and expertise to the respective cross-functional teams that review promotional materials in compliance with applicable regulations and guidance
Review and assess proposed promotional teams to evaluate their completeness, accuracy and compliance with applicable regulations and procedures; review and revise regulatory policies and procedures to ensure compliance with applicable regulations
Assist appropriate United Therapeutics personnel with the planning of proposed promotional materials and disease state materials
Maintain a thorough understanding of the FDA Office of Prescription Drug Promotion (OPDP) requirements (and other regulatory agency related departments, as appropriate). Serve as primary contact leading and facilitating communications with regulatory agency reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials or materials requiring pre-clearance, as applicable
In collaboration with Regulatory Informatics, ensure the management and maintenance of records and databases that support communication with OPDP and record keeping of submissions and related materials
Supervise and develop Regulatory Promotional Review staff. Conduct interviews, make hiring decisions, and provide salary recommendations. Monitor and assign work; coach, mentor and develop employees. Develop work plans and conduct performance evaluations
Perform other duties as assigned
BA/BS degree; scientific discipline preferred
10 years’ experience in the pharmaceutical industry, with at least 6 years’ progressive experience in Regulatory Affairs promotional review.
Significant experience managing direct reports
In-depth knowledge of regulations and guidance and their implementation with specific experience in the areas of advertising and promotion
Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside regulatory affairs, including upper management, and external government personnel
Significant experience communicating and negotiating directly with regulatory agencies
Demonstrated leadership, interpersonal and collaboration skills; ability to interact with management and resolve conflicts
Strong negotiation and decision-making skills
Excellent organization skills and ability to work on a number of projects with tight timelines
Experience in RIM software applications
Experience with MS Office, Adobe Acrobat, and required productivity applications
Ability to travel up to 30% as needed
Preferred Knowledge, Skills, and Abilities
Advanced degree in scientific discipline
Experience with regulations and guidance for promotional review in Canada
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia. As a group, we are relentless in our pursuit of “medicines for life” and continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers, and other orphan diseases.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.