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Director, Compliance The candidate will be responsible for enabling Santen Inc. to become and continue to be a truly ethical and compliant company through operational and business support in addressing compliance priorities and programs, establishing compliance policy, training, communication, monitoring and enforcement activities for the company, ensuring compliance risks are understood and well managed. A majority of responsibility focuses on advising the company on relevant industry laws and regulations that govern the pharmaceutical industry, as they relate to interactions with Health Care Professionals (HCPs), marketing and medical communications, other FDA related issues, and leading compliance initiatives. This position reports to Vice President, Legal and Compliance. Reviewing proposed HCP engagement arrangements. Approving remuneration to be paid to HCPs based on properly assigned tiers for them. Reviewing and drafting HCP consulting/honorarium agreements in cooperation with colleagues in charge of contract. Providing guidance accommodations provided to HCPs. Making necessary reporting. Monitoring and maintaining the mechanism to track HCP related expense tying to HCP master file. Reviewing medical information and communication materials, marketing strategies, and product-related communications. Responsible for advising on all regulatory (i.e., FDA related issues, etc.) matters. Responsible for advising on compliant and ethical conduct regarding grants and donations such as medical education grants, IST grants and travel grants, including: Sitting in grants/donation committee as a legal representative; Advising on grant/donation review procedures. Responsible for advising on privacy issues. Identify risk areas and review, revise and implement compliance related policies and guidelines such as compliance policy and HCP interaction and communication policy.
Qualification and Experience
The candidate must have Juris Doctor/law degree and licensed to practice in one jurisdiction required, healthcare compliance certification (CHC) preferred, with 10+ years of experience serving in a compliance, legal, regulatory or related role in the pharmaceutical/medical device industry. In-depth knowledge and understanding of pharmaceutical industry laws, regulations and guidelines involving off-label issues, anti-bribery and anti-corruption, customer/patient interactions, research misconduct is required. Thorough functional knowledge of the elements of a pharmaceutical compliance program and thorough knowledge and understanding of the pharmaceutical industry is needed.
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