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Manager, Healthcare Compliance Jobs
Company | BeiGene |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-27 |
Posted at | 10 months ago |
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
- Collaborate with Commercial Ops to support sampling activities, data analytics, and the federal and state transparency.
- Support the development and periodic review of compliance training programs for new and existing employees to ensure a thorough understanding and appreciation of the laws that impact the Company’s operations and how to conduct business practices appropriately.
- Provide practical business solutions that maintain the Company’s compliance within an evolving legal landscape.
- Manage internal policies, procedures, and compliance lines of communication, including the ethics hotline; the Company’s Compliance email inbox; and the compliance portions of the Legal and Compliance intranet page.
- Support the design, implementation and execution of compliance monitoring and audit programs based on Legal and Compliance policy requirements, industry risk areas and trends and incorporate feedback and observations into existing or new policies and procedures where appropriate.
- Assist with developing, enhancing and delivering elements of BeiGene’s on-going compliance communication strategy across the organization. Help drive compliance culture and campaign throughout the Company.
- Support global and regional compliance projects on an as-needed basis, including support of commercial, medical, and clinical teams and activities.
- Ownership and implementation of HCP Engagement/business justification processes (e.g., needs assessment, FMV) and technology solution.
- Provide support on policy and procedure implementation governing business operations, ensuring compliance with laws and regulations applicable to the Company.
- Provide timely guidance to relevant business units and stakeholders on compliance matters and inquiries relating to common HCP interactions, such as advisory boards, consulting engagements, speaker programs, sponsorships and grants.
- Identify emerging trends in compliance, anticipate the impact on processes, and proactively engage with business stakeholders to determine how to partner together to address them.
- N/A
- Proficiency in the Microsoft suite of tools including Outlook, Word, PowerPoint and Excel
- Strong expertise in compliance with laws, regulations, and industry codes relevant to the development and commercialization of pharmaceutical products.
- Strong critical thinking skills, attention to detail, adaptability, and professionalism.
- Excellent communication skills (oral and written; strong interpersonal skills in both one-on-one and group settings.
- Minimum of five years of combined experience in healthcare compliance, including in-house experience.
- Working knowledge and experience with U.S. healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, and federal and state transparency and compliance program disclosure laws, and U.S. and international industry codes (e.g., PhRMA, EFPIA, IFPMA).
- Ability to work independently as well as collaboratively with enthusiasm and accountability.
- Travel approximately 10-15%, including ex-US travel.
- Bachelor of Arts or Bachelor of Science required; J.D. or other advanced degree preferred but not required
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