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Senior Compliance Counsel/VP Compliance
Refer job# PMSW154692
 
Senior Compliance Counsel/VP Compliance Duties: Develop and implement effective compliance policies, standards, and procedures. Assess compliance training needs in light of current policies, external developments, and risk assessment. Develop, design, and implement compliance training to meet those needs. Understand the business environment and use analytical skills and experience to set compliance priorities and recommend options to minimize compliance risk. Provide a timely legal review of promotional and medical affairs materials.. Provide counsel on medical affairs activities, HCP engagements, promotional and marketing strategies and activities, FDA labeling, patient support programs, customer interactions, and other regulatory compliance matters. Develop and implement processes for reporting, documenting, investigating, and responding to compliance incidents, including, but not limited to, a monitoring plan to ensure that compliance policies and procedures are followed. Conduct periodic compliance risk assessments and assist in developing appropriate mitigation plans. Foster a culture of ethics and transparency. Stay current with applicable laws, rules, regulations, and industry trends affecting the company. Demonstrate strategic value and competence in applying legal skills to daily in-house corporate, business, compliance, and other matters. Perform other duties as may be assigned.

Qualifications. JD Degree from ABA-accredited law school. Valid license to practice law in California in good standing or ability to satisfy in house specialty requirements. 8+ years of pharmaceutical compliance experience required. Strong knowledge of laws, regulations, industry guidelines, and other requirements relevant to a pharmaceutical compliance program, including those related to fraud and abuse and anti-kickback laws, IOG, PhRMA, EFPIA and IRPMA guidelines, aggregate spend reporting requirements, and other key enforcement initiatives. High degree of professional ethics and integrity. Ability to juggle multiple activities, handle a high volume of work and work under pressure. Results-driven individual with meticulous attention to detail and accuracy to deliver high-quality work product. Ability to organize competing priorities logically; excellent time management skills with a proven ability to meet deadlines in a fast-paced environment. Analytically driven; able to extract and interpret data, break down problems, and deliver solutions. Ability to work both independently and as part of a highly collaborative team. Excellent interpersonal and customer service skills. Strong relationship building skills with cross-functional stakeholders at all levels; able to quickly operationalize strategic initiatives in a collaborative manner. Excellent written and verbal communication skills and negotiation skills.
 
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