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Senior Manager / Associate Director, Healthcare Compliance
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Job Description
Key Responsibilities
- Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program that aligns with industry standards and regulatory requirements, including federal, state, and international regulations, as appropriate.
- Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
- Lead the development and delivery of compliance training programs for employees at all levels.
- Conduct regular compliance audits, monitoring and risk assessments to identify potential areas of compliance vulnerability and risk.
- Assist in the completion of activities related to federal and relevant state transparency-driven compliance requirements.
- Manage the Company’s whistleblower hotline.
- Collaborate with legal, regulatory, and operational teams to provide compliance guidance and support for new initiatives and projects.
- Investigate compliance-related issues and coordinate with relevant stakeholders to ensure appropriate corrective actions are taken.
- Stay current with industry trends, regulatory changes, and best practices in compliance.
- Engage in such other activities as directed by the Senior Vice President, Legal.
Required Experience:
- Bachelor’s degree in life sciences, law, business, or a related field; advanced degree (e.g., JD, MBA) preferred.
- Minimum of 6 years of experience in compliance, regulatory affairs, or a related field within the pharmaceutical or biotech industry.
- Strong knowledge of FDA regulations, GxP standards, and other relevant compliance frameworks.
- Proven ability to interpret and apply complex regulations and guidelines to business practices.
- Excellent analytical, problem-solving skills.
- Well-rounded, experienced compliance expert who has played a key role on matters relating to the marketing and promotion of pharmaceutical products and possesses excellent business judgment concerning overall healthcare compliance and risk management.
- Ability to work effectively in cross-functional teams with a collaborative and hands-on approach.
- Ability to manage multiple tasks independently and simultaneously.
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