Position Summary The Compliance Senior Manager plays an important role in the continued design and implementation of the Company's healthcare compliance program. The Senior Manager will assist in the implementation, maintenance, and continued improvement of the Company's compliant and ethical practices and behaviors through close collaboration with internal and external business partners. This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Senior Manager will report to the Vice President, Compliance & Chief Compliance Officer. Primary Responsibilities
- Develop and maintain relevant policies, procedures, and work instructions related to key areas within compliance to guide the Company's operations
- Provide compliance oversight and support on Company initiatives, including HCP engagements, speaker programs, sponsorships, grants, and other initiatives involving interactions with healthcare professionals, healthcare organizations, patients, and patient advocacy groups
- Develop monitoring plans for desktop and live monitoring, deliver on the tactics outlined in those plans to ensure compliance with Company policies, and track and report progress of monitoring programs, including preparation of presentations to communicate findings to key management stakeholders
- Assist in auditing and monitoring activities, including data analytics support and trend analysis for reporting to senior management and the Board of Directors
- Support the development and execution of the Company's compliance training program, including ensuring that training participation rates are tracked and monitored
- Manage the Company's transparency collection and reporting infrastructure for US and ex-US reporting obligations
Competencies
- Deep understanding of laws, regulations, and governing norms applicable to pharmaceutical companies, including the Anti-Kickback Statute, Foreign Corrupt Practices Act, False Claims Act, and PhRMA Code on Interactions with Healthcare Professionals
- Expertise in US transparency laws and related reporting
- Comprehensive knowledge of legal, compliance, and regulatory landscape in the US
- Able to innovate, analyze, and solve problems while anticipating and identifying compliance risks
- Capable of strategic thinking and proposing innovative solutions to compliance-related challenges
- Strong project management and technical capabilities
- Excellent interpersonal, oral, and written communication skills
- Highly collaborative and able to communicate in an open, clear, complete, timely, and consistent manner
- Flexible and open to change in a rapidly growing environment
- Strong motivation and ability to champion a comprehensive compliance program that is well integrated with the Company's business and culture
- Team-player, able to work well with others, and communicate with cross-functional colleagues
- Comfortable in a fast-paced, results-oriented team
- Consistently shows initiative and willingness to take high levels of responsibility for complex initiatives
- High degree of personal, professional, and corporate ethics, integrity, and responsibility
Experience
- Bachelor's degree required; MBA, JD, healthcare compliance certifications, and/or project management certifications preferred
- A minimum of 5 years of pharmaceutical/biotechnology industry compliance experience, including experience within commercial-stage companies
- Experience developing and executing audits and monitoring
- Experience with business intelligence tools, LMS, CRM, and expense management systems
EEO Statement: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Benefit Statement: All regular-status, full-time employees of Geron are eligible to participate in the Company's comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron's intention to comply with all applicable federal, state, and local laws that apply to the Company's employees. Salary Statement: Offered compensation is determined based on market data, internal equity, and an applicant's relevant skills, experience, and educational background. The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations. General Salary Range: $140,000 to $155,000
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