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Years of Experience
Date Last Verified
Healthcare Compliance Office (HCO) Risk Mitigation Lead Duties: Will be the senior member of the HCO team accountable for coordinating the department’s compliance efforts across various risk areas. Will lead efforts relating to product promotional materials compliance and oversight and development and implementation of the compliance program for Government Affairs. Will report to the Vice President, Chief Healthcare Compliance Officer, NA Region Head for Healthcare Compliance and be a member of the Healthcare Compliance Office leadership team. Partner with the audit and monitoring teams to develop the annual audit and monitoring plan for product promotional materials risks. Partner with other Genentech business compliance teams to establish metrics and data monitoring reports. Partner with the investigations team to investigate all complaints regarding improper promotional materials practices. Partner with the training team on all compliance trainings concerning product promotional materials. Lead policy work streams concerning product promotional materials. Work with business partners in developing and overseeing the completion of corrective actions for product promotional compliance issues. Development and implementation of the Company’s compliance program for Government Affairs.. Contribute to annual and longer-range HCO Risk Assessment Plan and Work Plan development and implementation. Performing, as assigned, other HCO duties or projects. Where applicable, managing outside vendors to ensure on-time, on-target and within-budget deliverables.
Qualification and Experience
Qualifications: Bachelors Degree (life sciences, law, public policy, marketing, business, education, finance/accounting or related discipline preferred). JD Degree preferred. Healthcare Compliance Certification (before or w/in 6 months of appointment). 6+ years of work experience in legal, compliance, policy, auditing, training, communications or related discipline in the bio/pharma industry with a focus on promotional materials review and standards or government affairs compliance. 4+ years of previous experience effectively leading policy, program or project development from conception to implementation. A broad background in pharma/biotech compliance. Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Commitments. Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications. Works well within teams. Strong process-orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness. Strong influencing skills: proven track record and experience building and cultivating relationships with key partners and stakeholders across organizational levels. Must demonstrate in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.) with a focus on promotional materials review and standards and federal and state transparency requirements.
Job ID: 00452999
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