Manager Corporate Compliance

Profile

Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. By providing a foundation for all operations company wide, BioMarinu2019s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patientsu2019 lives. Role and ResponsibilitiesGeneral Compliance Program Support Support the development, implementation, and maintenance of Global Compliance & Ethics (GCE) Program activities, including compliance investigations and training and monitoring workstreams designed to facilitate adherence to compliance policies and healthcare compliance regulations. Support of GCE regulatory intelligence efforts, including application of new and existing FDA and OIG guidance documents, emerging state and federal regulations, and industry codes (e.g. PhRMA) to current policies, training and monitoring activities as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations. Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.u00A0Internal Investigations Support Provide support to Sr. Director, Compliance Counsel on all Internal Investigations of alleged violations of compliance policies, laws, regulations, or procedures. Develop corrective action plans where compliance violations have been established and track completion of corrective action activities. Support and participate in Internal Investigations Governance Committee. Support management of all records and executive read-outs related to Internal Investigations.Training Program Management Support Senior Director, Compliance counsel in creation and maintenance of comprehensive Corporate Compliance training plan in connection with compliance policies, including but not limited to: new hire orientation, role or franchise-based training curricula, anti-bribery and anti-corruption (ABAC) program, privacy, Internal Investigations, and promotional regulations. Facilitate creation of Compliance training content, including alignment across trainings on core Compliance concepts, determination of best formats and methods for training delivery. Seek feedback from trainees regarding the quality of training content and any unmet training needs. Review and manage Compliance training assignments in training management system for enterprise-wide, franchise-specific and executive training curriculums. Track and assist with record retention of all Compliance training records in training management system. Review and monitor Compliance training assignments and completion, including following-up with employees who are late on assigned training. Track and report out on training metrics, conduct internal surveys measuring effectiveness of, and employee satisfaction with, training conducted. Prepare regular briefing documents to keep Executive Management up-to-date on execution of Training Plan and training related activities.Monitoring Program Support Provide support to Director, Corporate Compliance in data gathering and execution of quarterly data monitoring activities related to employee adherence to Corporate Business Policies. u00A0 Participate in live monitoring of field activities such as patient events, advisory boards, symposia and hub activities. Update and oversee design and maintenance of monitoring dashboard for regional and global visibility to completion of annual monitoring activities. Manage communication to Sales Directors regarding annual Director-led monitoring requirements, track completion and documentation of Director-led monitoring of field teams.EducationA J.D. is preferred; a bacheloru2019s degree is required.u00A0 Experience4-6 years of experience working in the pharmaceutical/healthcare legal/compliance/internal audit field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.Experience with statutes, regulations, guidance documents, enforcement trends, and best practices related to the pharmaceutical, biotechnology, and/or healthcare industry generally.Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.Demonstrated effectiveness operating in complex organizational and regulatory environments.Excellent written, oral, and presentation skills.A strong sense of professionalism, and the drive to provide superb and timely support to internal clients.Strong problem solving, risk analysis, and project management skills.Demonstrated ability to partner effectively with others in addressing complex issues.Strong persuasive skills, sound business judgment, and a sense of humor.Motivated, self-starter with ability to appropriately prioritize issues, drive projects, and allocate resources. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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