Associate Director Regulatory Advertising & Promotion

Regulatory Affairs Bothell, Washington South San Francisco, California


Description

Responsibilities:

Responsibilities will include, but are not limited to, the following:

  • Supporting or conducting interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s)
  • Reviewing and approving consumer and professional promotional materials for marketed products, corporate communications, and educational and training materials, via the promotional review committee (PRC) process
  • Acting as the primary Regulatory Advertising & Promotion (A&P) point of contact for the PRC for assigned product(s)
  • Providing strategic regulatory advice on promotional materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives
  • Contributing to/providing regulatory advisory submission strategies, preparing communications, and overseeing the timely and accurate submission of promotional materials to OPDP for assigned product(s)
  • Maintaining up-to-date knowledge of US and Canadian regulatory promotional environment and advising internal stakeholders on trends and pertinence to existing company materials/activities
  • Monitoring the competitive landscape to stay abreast of promotional and advertising strategies and activities
  • Reviewing and approving non-promotional scientific and medical communications for development stage products, via the medical/legal/regulatory affairs (MLR) review committee process
  • Providing strategic input during product labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising
  • Collaborating with key stakeholders in areas such as Marketing, Medical Affairs, Corporate Communications, Labeling, and Legal to develop compliant messaging and materials in support of business goals and objectives
  • Establishing working relationships and managing communication with Regulatory A&P colleagues at co-promotion partner companies
  • Cross-training between products to ensure continuous Regulatory A&P support for stakeholders
  • Developing and updating written departmental guidance and procedures
  • Continually assessing A&P-related processes and procedures to enhance efficiencies and compliance
  • Designing and conducting training for internal employees
  • Coaching and mentoring junior staff

Qualifications:

  • Bachelor’s degree (BA or BS) in a scientific or pharmacy discipline required.  Advanced degree (MS, MPH, PharmD, PhD, or JD) preferred
  • 8+ years pharmaceutical industry experience with 4+ years in Regulatory Affairs Advertising & Promotion
  • 2+ years of oncology experience preferred
  • Expert knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus on advertising and promotion
  • Knowledge of Canadian advertising and promotion regulations and related codes preferred
  • Familiarity with labeling regulations
  • Experience with pharmaceutical products
  • Experience working with the FDA, specifically OPDP
  • Experience with healthcare economic outcome research a plus
  • Excellent project management skills, attention to detail, and ability to manage multiple projects/priorities
  • Innovator of new ideas and best practices
  • Ability to recognize potential problems and identify potential solutions
  • Outstanding attention to detail
  • Ability to establish and maintain effective working relationships with a diverse range of cross-functional stakeholders
  • Ability to influence cross-functional teams and work effectively with senior management
  • Strong capability to work in a team environment while performing independently
  • Strong business acumen and the ability to see business drivers outside of functional area
  • Ability to contribute to a continuous learning and process improvement environment
  • Proven track record of decision making in an ambiguous environment
  • Domestic travel may be necessary

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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