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Associate Regulatory Compliance PA Open (J#26643)

Title: Associate Regulatory Compliance
Company: RT Management

The primary responsibility of this position is to provide specific and value-added regulatory guidance for all OIG and DDMAC compliance issues,assist in training the sales force as needed, in compliance with the Healthcare Compliance SOPs to ensure corporate compliance with OIG, PhRMA Code, and ACMME initiatives and adopted guidance documents. Prepare and offer project teams guidance on DDMAC submissions for all products, pre- and post-launch. The incumbent will also formulate and recommend the Company's position on regulatory matters concerning policy and objectives when responding to queries from the sales force regarding state requirements and Company's compliance SOPs, in collaboration with a representative from Corporate Legal. The incumbent will serve as a member of Company's launch teams and copy and publication review teams and as a liaison by representing the company and its products to outside consultants, organizations, and government agencies when requested. In addition, the incumbent provides direct support to Vice President, Regulatory Affairs on all Regulatory Affairs concerns and provides guidance and direction to the Regulatory Affairs support team.

QUALIFICATIONS: o BA/BS, MA/MS degree in a scientific discipline. An MBA or JD preferred
o 10 years professional/exempt level pharmaceutical experience involving positions of increasing responsibility in Regulatory Affairs, Development, Compliance or Quality Assurance with at least 3 years experience in pre- and post-marketing product life-cycle activities.
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