Post-Doctoral PharmD Fellow: Regulatory Affairs - Advertising and Promotion

Location
Bothell, WA, United States
Posted
Oct 25, 2018
Ref
oOsI8fwQ
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
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 - Advertising and Promotion 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 - Advertising and Promotion. The fellow will work closely with the Regulatory Affairs - Advertising and Promotion 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 Value and Outcomes, Corporate Communications, Health Economics and Outcomes Research, Investor Relations, Legal Affairs, Marketing, Medical Affairs, and Regulatory Affairs.

The fellow will support the US and Canada program for 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.

Responsibilities:
  • Monitoring, analyzing, and summarizing FDA Office of Prescription Drug Promotion (OPDP) enforcement actions and evolving regulatory guidance
  • Coordinating OPDP regulatory submissions
  • Participating in the review of, and provide regulatory advice on, promotional materials, non-promotional medical/scientific communications, and national congress assets
  • Developing and delivering presentations as needed to the promotional review committee and other internal groups
  • Working collaboratively with internal partners and stakeholders
  • Travel including, but not limited to, attendance at key sales and marketing meetings, as well as annual ASCO, ASH, and ASHP meetings
  • Opportunity to help shape the fellowship for future applicants


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/11609950/post-doctoral-pharmd-fellow-regulatory-affairs-advertising-and-promotion

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

Questions? Please email fellowship@seagen.com

Application deadline is Friday, November 16th, 2018. No references necessary until final onsite interview at Seattle Genetics.