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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. BENLYSTA™ (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. ZALBIN™ (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 visit www.hgsi.com for further information on our company and to apply on-line for this position.
Does the idea of working in a high potential company with an innovative pipeline of drug candidates appeal to you? Are you ready to be immersed in a role that offers challenge, a variety of responsibilities, and a chance to help the company succeed in bringing our first drug to market? We are actively recruiting for a seasoned Senior Medical Writer who can operate independently in a highly energized environment.
Responsible for organizing and analyzing clinical trial data, interpreting statistical reports, and writing clinical study reports and comprehensive data summaries for submission to regulatory authorities. Responsible for coordinating team review of these documents. Other responsibilities include writing/editing abstracts, presentations, and clinical trial manuscripts for scientific meetings and publication in peer-reviewed journals. The senior medical writer will provide editing/writing support to the project team as needed for documents such as protocols, Investigator Brochures, and Annual Reports. The senior medical writer will take a lead role in the development of formats and guidelines for clinical documentation. The individual must demonstrate the ability to handle multiple priorities and interface with individuals from various departments.
JOB DUTIES:
• Write and edit clinical reports, integrated clinical summaries (ISS, ISE), and other regulatory documents
• Write and edit manuscripts for scientific journals (may include nonclinical journal articles)
• Summarize data from clinical studies
• Review and edit clinical study tables, listings, and Analytical Plans
• Develop and edit clinical document templates that are compatible with ICH guidelines and FDA electronic submissions guidances
• Function as a department representative on a therapeutic project team
• Keep abreast of professional area through the internet, conferences, and meetings
• Manage the work of medical writing contractors and medical writers
• Other duties as assigned
Requirements
Minimum Qualifications:
• Bachelor’s Degree in a related science (Biology, Microbiology, Chemistry, etc) with a minimum of 8 years of related medical writer experience, preferably in the pharmaceutical/biotechnology industry
• Or, a Master’s degree in a related science with at least 3 years of related experience.
• Or, a PhD degree in a related science with at least 1 year of related experience
• Ability to work within a computerized environment, with basic knowledge of databases and advanced knowledge of word processing.
• A solid understanding of scientific/medical terminology and basic statistics
• Knowledge of relevant ICH/FDA regulations
• Excellent writing, editing, and communication skills
• Excellent organizational skills and attention to details
• Ability to work effectively on a team and strong interpersonal skills.
• Prior supervisory experience preferred
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