United BioSource Corporation (UBC), a wholly owned subsidiary of Medco Health Solutions, Inc. is a global scientific and medical affairs organization that partners with life science companies to make medicine and medical products smarter for all stakeholders in the health care landscape. The major components of UBC’s business are as a leader in late-stage clinical development; safety and risk management; health economics; outcomes research; pricing and reimbursement and medical publications and communications. In this role, an incumbent would be responsible for supporting scientific experts and research professionals by providing legal expertise in the areas of regulatory compliance, information privacy, government agency interaction and general health care related expertise.
Other related duties are implied or may be assigned as required.
Provide counsel on a wide variety of regulatory and compliance related matters applicable to our business and customers including laws governing fraud, waste and abuse; FDA pre- and post-drug approval issues; privacy; self-referral; and PhRMA Code
Draft and negotiate proposals and contracts with customers, clinical sites and investigators
Serve as key participant in efforts to proactively identify and mitigate potential legal and compliance risks associated with programs and products
Provide legal support for permitted combined service offerings across Medco affiliated companies
Provide regulatory and compliance support on reimbursement and licensure related issues
Oversee interpretation and communication of new health care related regulations
Serve as liaison with internal and external compliance and privacy teams
Review policies and procedures to ensure adherence to corporate and legal requirements and physical and electronic security under HIPAA
Job Requirements :
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
JD and a minimum of 3 - 5 years relevant legal experience in compliance / regulatory legal matters
Demonstrated experience preparing/reviewing and negotiating commercial agreements involving pharmaceutical manufacturers
Strong and broad knowledge of laws governing clinical trial, specialty pharma, scientific research and related services/businesses and compliance best practices
Technical/Computer Skills: MS Office Suite
Interpersonal Skills .
Strong communication skills including the ability to translate legal concepts into layman’s terms and assess business risk
Must be able to communicate verbally and in writing at all levels of the organization
Must be able to manage a heavy workload and exercise excellent judgment in executing responsibilities
Must be able to work effectively in a complex matrix organization
The ideal candidate will have extensive experience in healthcare / regulatory legal matters, with at least 3-5 years of associate-level experience from a reputable law firm, or as an in-house attorney. For immediate consideration please email your resume and salary requirements to email@example.com. Please note that submittals without salary listed may not be considered.
United BioSource Corporation - 4 years ago
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