Associate Director, Compliance
Burlington, MA
Full Time
Legal
Experienced
The Company:
It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together.
PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.
Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung.
Position Overview:
The Associate Director of Compliance is a key role within the U.S. Legal and Compliance team with responsibility for overseeing the compliance program that governs corporate conduct and reflects our commitment to ethical business standards, This role will work cross-functionally to drive ethical behavior and risk identification and mitigation. A core focus will be to bring risk-based compliance strategies across the commercial, business operations, medical and related functions to provide guidance that will impact how our company interactions with customers and HCPs. . While this role is focused on the US organization, it will have regular interactions with our Global Corporate Headquarters in Taiwan and other global affiliates.
This is a hybrid role based out of our U.S. Headquarters in Burlington, Massachusetts. It will require regular U.S. travel.
Job Responsibilities:
Self-starter and life-long learner with a strong work ethic and excellent interpersonal skills who
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.
It is unlawful in Massachusetts to require or administrer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together.
PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.
Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung.
Position Overview:
The Associate Director of Compliance is a key role within the U.S. Legal and Compliance team with responsibility for overseeing the compliance program that governs corporate conduct and reflects our commitment to ethical business standards, This role will work cross-functionally to drive ethical behavior and risk identification and mitigation. A core focus will be to bring risk-based compliance strategies across the commercial, business operations, medical and related functions to provide guidance that will impact how our company interactions with customers and HCPs. . While this role is focused on the US organization, it will have regular interactions with our Global Corporate Headquarters in Taiwan and other global affiliates.
This is a hybrid role based out of our U.S. Headquarters in Burlington, Massachusetts. It will require regular U.S. travel.
Job Responsibilities:
- Serve as a subject matter expert to drive the development and implementation of policies, procedures, processes and training in accordance with laws, regulations, guidelines and codes, such as the Anti-Kickback statute and PhRMA Code.Provide guidance and compliance oversight on company initiatives, including HCP engagements, speaker programs, sponsorships, grants and other initiatives involving interactions with healthcare professionals, healthcare organizations, patients, and patient advocacy groups
- Manages U.S. spend transparency reporting program and vendors and advises on other transparency and reporting pharma requirements Support and prepare required federal and state transparency reports, including data review, verification, corrections, and timely submissions.Proactively identify data integrity issues, determine root causes, and implement corrective actions.
- Serve as a subject matter expert to drive the development and implementation of policies, procedures, processes and training in accordance with laws, regulations, guidelines and codes, such as the Anti-Kickback statute and PhRMA Code.Provide guidance and compliance oversight on company initiatives, including HCP engagements, speaker programs, sponsorships, grants and other initiatives involving interactions with healthcare professionals, healthcare organizations, patients, and patient advocacy group.
- Manages U.S. spend transparency reporting program and vendors and advises on other transparency and reporting pharma requirements Support and prepare required federal and state transparency reports, including data review, verification, corrections, and timely submissions.Proactively identify data integrity issues, determine root causes, and implement corrective actions.
- Develop and maintain relevant policies, SOPs and training to ensure that the program is aligned with the OIG Guidelines for compliance programs and addresses the most current industry codes of conduct
- Execute auditing, monitoring, and reporting programs and processes
- Provide compliance reports and updates on a regular basis]
- Oversight of the US Hotline and investigations including independently evaluating hotline and other source reports, conducting appropriate investigations and outcomes, and assisting with determining appropriate corrective action when necessary Plan and coordinate healthcare and corporate compliance-based risk assessments and internal audits/monitoring to proactively identify and address compliance vulnerabilities
- Plan, execute and track regular compliance training for new and current employees.
- Serve as the primary U.S. compliance point of contact for colleagues and provide risk identification and mitigation support in the development and implementation of company strategies and tactics
- Support the business on obtaining access to and training of key compliance tools including Risk Assessments, Vendor Due Diligence, Needs Assessment, Healthcare Professional Tiering and Fair Market Value
- B.A./B.S. degree required (advanced degree preferred, MBA, MS, JD)
- 8+ years of compliance experience within the biotech, medical device or pharmaceutical industry, including 4+ experience within a commercial stage company
- Excellent communication, analytical and problem-solving skills
- Certified in Healthcare Compliance (CHC) or Project Management Professional (PMP) preferred
- Knowledge of and experience addressing compliance with laws, regulations, and guidance that affect the pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing and price reporting/disclosure laws
- Requires the ability to be adaptable to changes and comfortable in creating new processes and implementing change management
- Experience with business expenditure applications, travel and expense reporting tools, and other financial applications is required. Experience with hosted aggregate spend applications, customer master data sets, and business intelligence tools is preferred.
Self-starter and life-long learner with a strong work ethic and excellent interpersonal skills who
- Demonstrates excellent organization, communication, and project management skills
- Enjoys working collaboratively and cross-functionally on teams, as well as independently
- Proactively solves problems and makes decisions
- Thrives in a fast-paced and dynamic environment
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:
- Comprehensive medical coverage
- Dental and vision coverage
- Generous paid time-off
- 401(k) retirement plan with competitive company match
- Medical & Dependent Care Flexible Spending Account
- Up to $150 monthly cell phone reimbursement
- Employee Assistance Program
- Free parking
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.
It is unlawful in Massachusetts to require or administrer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.
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