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.
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
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.
Application deadline is Friday, November 30th, 2018. No references necessary until final onsite interview at Seattle Genetics.
About Seattle Genetics
Seattle Genetics is an emerging multi-product, global biotechnology company and the largest based in the Pacific Northwest. We develop and commercialize transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) utilizes the company’s industry-leading antibody-drug conjugate (ADC) technology and is approved for the treatment of multiple CD30-expressing lymphomas.
Beyond ADCETRIS, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing or planned pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer utilize our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors.
With multiple global product opportunities, significant research into advancing ADC technology and an emerging complementary immuno-oncology technology, we are positioned to transform cancer therapy.