Regulatory Compliance Attorney

Regulatory Compliance Attorney

Location  Rockville, MD

Job ID 2738 Employment Status  Full-Time Regular

Required Experience  2-5 years

Required Education  Doctorate Degree or Equivalent

Required Travel  No

Relocation Available  Yes

Summary/Description Human Genome Sciences (HGS)is a biopharmaceutical company with approximately 800 employees and world-class R&D and manufacturing facilities based in Rockville, MD. We have three promising products in late-stage development - one, raxibacumab, already commercialized with sales to the U.S, Government and two moving toward commercialization. BENLYSTAT (formerly LymphoStat-B) has successfully met its primary endpoint in the first of two Phase 3 trials in systemic lupus, and we expect to have results of the second BENLYSTA Phase 3 trial in November 2009. ZALBINT (formerly Albuferon) has completed Phase 3 development in chronic hepatitis C, and we expect the submission of global marketing applications in fall 2009. We are developing both of these products in collaboration with world leaders in the pharmaceutical industry. Further, in July 2009, we secured a new purchase order for 45,000 doses of raxibacumab, a drug to combat inhalational anthrax, to be delivered to the U.S. Strategic National Stockpile over a three-year period. At HGS, people are the key to our success. We share a passion for scientific and business innovation, creating unique opportunities to contribute to the commercialization phase of our products. At HGS, you will have opportunities to learn and grow; interacting with talent of the highest caliber, and you will be supported by a culture committed to employee and leadership development. We offer a competitive salary and benefits package. HGS is an Equal Opportunity Employer EOE/AA M/F/D/V Please visitwww.hgsi.comfor further information on our company and to apply on-line for this position. We are currently seeking a broadly talented Regulatory Compliance Attorney. If the challenge of joining a company during this critical transition and being the first and only incumbent appeals to you, keep reading. In this newly created position, you will report to the General Counsel and work on a day-to-day basis with the sales and marketing, clinical and medical affairs teams to establish and maintain a high-quality health care compliance program. Requirements The successful candidate will have 5-7 years of legal experience with a predominant concentration in pharmaceutical/life sciences regulatory law (as in-house counsel or in a law firm), including substantial work for pharmaceutical, biopharmaceutical or other life sciences industry clients; knowledge of Food, Drug & Cosmetic Act and FDA regulations; extensive experience working with marketing and sales teams, and an in-depth understanding of drug promotion (labeling, advertising, fraud and abuse, anti-kickback and R & D); understanding of reimbursement strategies and third party payor agreements; and understanding of regulatory compliance issues in the manufacturing area.

Please refer to job code hgs-9686 when responding to this ad.

Category:	Other Jobs
	> Attorney
Location:	Rockville, MD
County:	Montgomery County
ZIP Code:	20847
Pay Rate:	Open
Job Terms:	full time
Company:	Human Genome Sciences
Phone:	email only please
Fax:	email only please