Senior Director, Promotional Regulatory Affairs
Category: Research & Development | Country: United States | State: Pennsylvania | City: Philadelphia | Type: Regular, Full Time | Job ID: 4419
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
- Lead and manage the Global Promotional Regulatory Affairs team in completing activities related to regulatory oversight of advertising and promotion for both US and international markets delivering on corporate, department and team objectives.
- Plans budgets and forecasts people resources to effectively deliver on team objectives. Hold employees accountable to deliver individual and department objectives within timelines and resources.
- Develops a highly competent and technically skilled team.
- Coach and mentor staff ensuring appropriate levels of accountability for delivering according to Jazz core competencies and values, and clearly communicate across Jazz.
- Accountable for proper governance of risk based decisions and applies regulatory expertise to the review and approval of promotional and other commercial materials (e.g., training, disease education).
- Represents Global regulatory Affairs with senior management to provide direction and advice on regulatory issues related to product and disease state communications, advertising and promotion.
- Makes risk base decisions, adequately assesses decisions, and escalates to senior management appropriately and according to company policies, procedures and established precedents.
- Maintains awareness of and communicates with team members regarding changing regulatory agency requirements; provides training and regulatory intelligence related to advertising and promotional material to the organization as required.
- Through collaboration with other members of Global Regulatory Affairs, ensures the commercial regulatory perspective is considered in the creation of global development plans and related R&D activities.
- Is an active member of the GRA Leadership Team, GRA People Leader Forum, and an ad hoc member of the Compliance Committee as requested by the committee chair.
- Models and encourages adherence to the Jazz Values and Mission.
Required Knowledge, Skills, and Abilities
- 15 years of relevant experience in the pharmaceutical industry, including experience in regulatory, legal, compliance, or related disciplines
- Highly resilient and achievement-oriented, with ability to succeed in an environment that demands fast but well-founded decision making on a vast number of multidisciplinary issues.
- Exceptional verbal and written communication skills and collaborative interpersonal skills
- Broad knowledge of regulations, codes of practice, and associated guidelines pertaining to advertising and promotion for prescription medicines.
- Demonstrated ability to identify emerging issues and initiate actions to recommend solutions, including in areas of ambiguity.
- Proven track record of driving performance within a matrixed environment.
- Experience directly managing people and/or leadership experience leading global teams, projects, and programs or directing the allocation of resources.
Required/Preferred Education and Licenses
- Bachelor’s degree in business, law or life sciences is required, advanced degree is preferred.
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.