Associate Director, Compliance

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 responsibilities for maintaining and evolving the company’s U.S. compliance and ethics program, working with the US and Global legal/compliance teams and leadership. This compliance position will work cross-functionally to embed compliance principles into everyday operations, mitigating risk while fostering a culture of ethics and integrity across the organization. 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:

• Work alongside employees and company leadership to maintain and further develop throughout the organization a strong sense of compliance and ethics, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving
• 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
• Execute auditing, monitoring, and reporting programs and processes
• Provide compliance reports and updates on a regular basis, and as directed or requeste
• Assist with internal investigations and resolution of compliance violations, as required, to promote a speak-up culture and compliance with all applicable laws and internal policies
• Plan and coordinate healthcare and corporate compliance-based risk assessments and internal audits/monitoring to proactively identify and address compliance vulnerabilities
• Develop and maintain relevant policies, procedures, and work instructions related to key area within Compliance to guide the company’s operations
• 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
• Develop and/or identify new work processes, tools or resources that will have broad applicability throughout the organization; contribute ideas for achieving organizational goals
• 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
• Manages U.S. spend transparency reporting program and vendors and Advises on other transparency and reporting pharma requirements

Qualifications, Professional Skills, and Preferred Experience

• 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
• Prefer experience managing compliance budgets and vendors
• Experience developing and executing auditing and monitoring (e.g., field sales, speaker programs)
• Requires the ability to be adaptable to changes and comfortable in creating new processes and implementing change management
• Experience with SAP, Concur and ability to collect and analyze data through various data sources, including but not limited to, contract management systems, ERPs etc.

Personal Attributes
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

Benefits of working with our team:
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

EEO Statement:
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.

https://us.pharmaessentia.com/careers/