US-MD: Rockville-Intern - Regulatory Affairs

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Job Title: Intern - Regulatory Affairs
Job Location: MD: Rockville
Pay Rate: Open
Job Length: full time
Start Date: 2008-03-24

Company Name: Human Genome Sciences
Contact: HR
Phone: email only please
Fax: email only please

Description: Intern - Regulatory Affairs

Location Rockville, MD

Job ID 2509 Employment Status Internship

Required Experience 0-2 years

Required Education High School Diploma or Equivalent

Required Travel No

Relocation Available No



Summary/Description Human Genome Sciences (HGS)is located in the Washington, DC metro area, and was founded in 1992 with the goal of creating a global biopharmaceutical company to discover, develop, manufacture, and market gene-based drugs to address unmet medical needs. We have a significant product pipeline with seven products in clinical development, including drugs to treat hepatitis C, lupus and other autoimmune diseases, anthrax exposure, and cancer. In recent years, we have progressed toward becoming a late stage development and commercialization company, and we have recently started Phase 3 trials for three of our key development programs. HGS is developing an innovative new treatment for systemic lupus erythematosus (SLE), which would be the first new treatment for lupus in nearly 40 years. This product, belimumab, is being co-developed and commercialized with Glaxo SmithKline. We are also developing a long-acting interferon alpha, Albuferon, for Hepatitis C, along with Novartis. HGS has also been awarded a two-phase contract with US government to supply them with ABthrax, a monoclonal antibody treatment for anthrax, for the Strategic National Stockpile, which we expect to deliver in 2008. 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 visit www.hgsi.com for further information on our company and to apply on-line for this position.JOB SUMMARY Assist with review and fact checking of regulatory documents and/or reports. Responsible for entering data into data formats. Assist with submissions to regulatory agencies. Assist in certain aspects of BLA (Biological License Application) preparation. JOB DUTIES: Duties may include, but are not limited to, the following . Performing directed tasks related to BLA preparation . Assist in submissions to regulatory agencies (eg, Food and Drug Administration) . Entering data into specified formats . Fact checking reports and/or other documents . Work within the document management system environment . Other projects as directed by managers . Attend training classes as necessary Requirements Minimum Qualifications: . Rising high school senior or college student . A solid understanding of biology or biochemistry . Excellent organization, writing, editing, and communication skills . Ability to work effectively on a team and strong interpersonal skills. . Experienced with Word, Excel, internet searching




Please refer to Job code hgs-9100 when responding to this ad.


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