Manager Healthcare Compliance
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POST DATE 8/24/2016
END DATE 10/23/2016
JOB DESCRIPTIONAPPLY Company Overview
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes website at www.alkermes.com .
Manager, Healthcare Compliance
The Compliance Manager will work with the Associate Director of Healthcare Compliance on the Compliance Monitoring Plan. This is a field-based position that will require extensive travel.
* Conduct in-person monitoring of Medical Professional Services and Commercial activities to ensure compliance with applicable laws, regulations and company policies
* Review commercial documentation to ensure compliance with company SOPs and policies
* Track and report progress of Compliance Monitoring
* Provide daily guidance and handle field inquiries from the Sales and Marketing personnel about policies, procedures, compliance risks and other compliance-related matters
* Provide training to internal organizational clients with respect to topics such as anti-bribery and FDA regulations and company policies, as well as customized training based on questions from the organization, identified risk areas and developments in the law
* Collaborate with internal departments for various monitoring requirements
Education and Experience:
* BS/BA required
* Minimum of 5 years of experience required and within the pharmaceutical/biotech industry preferred
* Knowledge of laws, regulations, industry guidance and best practices regarding compliant sales and marketing activities, primarily through experience in the pharmaceutical industry and/or with pharmaceutical manufacturer activities
* This is a field based role and must be able to travel (at least 60%)
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.