PharmD Fellow: Oncology Regulatory Affairs - Labeling

Recruiter
Seattle Genetics, Inc.
Location
Bothell, Washington
Posted
Oct 31, 2019
Closes
Nov 20, 2019
Ref
bff58e53bcce
Organization Type
Corporate
Summary:

The Seattle Genetics Regulatory Affairs Fellowship is a one-year, experiential program at Seattle Genetics based in Bothell, WA. The purpose of this program is to prepare PharmD fellows for career opportunities in pharmaceutical Regulatory Affairs - Labeling by providing in-depth biopharmaceutical industry experiences and enhancing clinical knowledge.

The Seattle Genetics Regulatory Affairs Fellowship provides a unique opportunity for a PharmD graduate to gain training and hands-on experience in a specialized area of Regulatory Affairs - Labeling. The fellow will work closely with the Regulatory Affairs - Labeling Lead on marketed and development-stage products. The fellow will have the opportunity to interact cross-functionally with a broad group of team members and key stakeholders, including: Clinical Development, Drug Safety, Clinical Pharmacology, Commercial, Legal, and Medical Affairs.

The fellow will support ADCETRIS® (brentuximab vedotin), an antibody-drug conjugate (ADC) directed to the CD30 surface antigen on cells using Seattle Genetics' proprietary ADC technology. The fellow will also support Seattle Genetics' pipeline programs, including late-stage agents enfortumab vedotin and tucatinib.

Responsibilities:
  • Participate in the development of company positioning for product labels
  • Create labeling content in support of NDA, BLA, and global marketing applications
  • Conduct competitive label intelligence research
  • Coordinate label responses and updates during label negotiations with Health Authorities

Qualifications:
  • A Doctor of Pharmacy (PharmD) degree from an ACPE accredited institution
  • Analytical, planning and organizational skills
  • Possess good communication skills, including oral, written and presentation
  • Self-motivated, energetic, able to work and learn independently
  • Ability to thrive in a fast-paced, dynamic environment
  • Good medical and scientific judgement, attention to detail, and excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally

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.

To apply for this position, please visit: https://careers.ashp.org/jobs/12966247

To learn more about the Seattle Genetics Fellowship program, please visit http://bit.ly/SeagenFellowship20

Questions? Please email fellowship@seagen.com

Application deadline is Monday, November 25 th , 2019.

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