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Post-Doctoral PharmD Fellow: Oncology Regulatory Affairs, RegulatoryLabeling/Advertising & Promotion

Post-Doctoral PharmD Fellow: Oncology Regulatory Affairs, Regulatory Labeling/Advertising & Promotion

Development Bothell, Washington


Description

Position at Seagen

Summary:

The Seagen Regulatory Labeling/Regulatory Advertising & Promotion Fellowship is a one-year, experiential program at Seagen based in Bothell, WA. The purpose of this program is to prepare PharmD fellows for career opportunities in pharmaceutical Regulatory Affairs by providing in-depth biopharmaceutical industry experiences and enhancing regulatory knowledge and application.

The Seagen Regulatory Labeling/Regulatory Advertising & Promotion Fellowship provides a unique opportunity for a PharmD graduate to gain training and hands-on experience in a specialized area of Regulatory Affairs. The fellow will work closely with Regulatory Labeling and Regulatory Advertising & Promotion leads on marketed and late-stage development products. The fellow will also have the opportunity to interact cross-functionally with key stakeholders including Clinical Development, Drug Safety, Clinical Pharmacology, Biostatistics, Commercial, Medical Affairs, Corporate Communications, Legal Affairs, and Health Economics and Outcomes Research.

The fellow will have the opportunity to support Seagen's marketed products, including ADCETRIS(R) (brentuximab vedotin ), PADCEV(R) ( enfortumab vedotin ), TUKYSA(R) (tucatinib), and TIVDAK(R) ( tisotumab vedotin )  as well as pipeline products in late stages of clinical development.

Responsibilities:

  • Support the development and maintenance of Target Product Labels, Company Core Data Sheets, and USPIs
  • Support preparation for Health Authority label negotiations
  • Monitor and analyze competitor labels and labeling precedents
  • Monitor, analyze, and summarize FDA Office of Prescription Drug Promotion (OPDP) enforcement actions and evolving regulatory guidance
  • Coordinate OPDP regulatory submissions
  • Participate in the review of promotional materials, non-promotional medical/scientific communications, and national congress assets
  • Work collaboratively with internal partners and stakeholders to inform and achieve desired regulatory outcomes
  • Opportunity to help shape the fellowship for future applicants

Qualifications:

  • Doctor of Pharmacy degree from an ACPE accredited college of pharmacy prior to fellowship start date 
  • Evidence of appropriate analytical, planning and organizational skills 
  • Basic knowledge of the pharmaceutical industry including Product Development, Manufacturing, Regulatory Affairs, Medical Affairs, and Commercial operations 
  • Possess good communication skills, including oral, written, and presentation skills 
  • Self-motivated, energetic, able to work and learn independently 
  • Ability to thrive in a fast-paced, dynamic environment

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.

To learn more about the Seagen Fellowship program, please visit :  https://www.seagen.com/careers/fellowships

Application deadline is Wednesday, November 17 th . Please include the following with your application (references not required at this time):

  • Curriculum vitae
  • Letter of intent

Additional questions? Please  email [email protected]

Company
Seagen
Posted
10/03/2021
Location
Bothell, WA 98011, US