Associate Director Regulatory Advertising & Promotion

Development Bothell, United States


Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us! 

Summary:  

The Associate Director, Advertising & Promotion provides regulatory guidance and strategy to ensure regulatory requirements and business needs are met compliantly. The Associate Director will act as the promotional review committee representative and the Office of Prescription Drug Promotion liaison for assigned product(s). The Associate Director may manage direct report(s) within the Advertising & Promotion function, according to business need. 

Principal Responsibilities:  

  • Reviews and approves US and Canadian promotional materials, non-promotional medical/scientific/corporate communications, and congress assets 
  • Represents Regulatory Advertising & Promotion function in cross-functional review team meetings for promotional materials, non-promotional materials, and labeling 
  • Directs Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) regulatory submissions 
  • Directs submissions to Pharmaceutical Advertising Advisory Board (PAAB)  
  • Acts as the OPDP liaison for assigned product(s) 
  • Identifies potential regulatory risks and develops strategies to avoid/address/mitigate 
  • May act as line manager arbiter for promotional review committee (PRC) review topics 
  • Develops functional area and cross-functional written procedures 
  • Updates internal stakeholders on regulatory enforcement trends and their impact to ongoing/future activities 
  • Advises on new and existing regulations, guidance, regulatory actions, and competitive landscape 
  • Onboards and trains new PRC members as a Regulatory Advertising & Promotion subject matter expert 
  • Develops and executes regulatory strategy, independently or in collaboration with more senior personnel 
  • Coaches and mentors more junior staff  
  • May supervise more junior individual contributors 

Required Qualifications:  

  • 8+ years pharmaceutical industry experience 
  • 6+ years regulatory advertising & promotion experience 
  • BA/BS, preferably in life sciences; advanced degree preferred 

Preferred Qualifications:  

  • 2+ years experience in relevant disease area(s) 
  • Ex-US regulatory advertising & promotion experience  
  • Advanced degree preferred 


As t
he leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit 
www.seagen.com.  

The hiring pay range for this position is $162,000 to $209,000 per year based on skills, education and experience relevant to the role.   Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.  

Seagen 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.  

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law. 

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