What are the responsibilities and job description for the Compliance Officer position at PharmaEssentia U.S.A.?
Position Overview:
This is a new role within the U.S. Legal and Compliance team reporting to the VP, Head of US Legal and Compliance. This senior level compliance role will play a critical strategic role in overseeing and developing 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.
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 in Europe 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 (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.
Key Responsibilities:
Self-starter and life-long learner with a strong work ethic and excellent interpersonal skills who
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.
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.
This is a new role within the U.S. Legal and Compliance team reporting to the VP, Head of US Legal and Compliance. This senior level compliance role will play a critical strategic role in overseeing and developing 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.
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 in Europe 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 (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.
Key Responsibilities:
- Manage the comprehensive healthcare and corporate compliance and ethics program, ensuring alignment across all functions, including clinical development, medical affairs, and commercial teams
- Collaborate creatively with stakeholders and provide broad spectrum compliance support
- Develop and implement auditing, monitoring, and reporting programs and processes
- Establish and implement periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk
- Respond to alleged violations by evaluating or recommending the initiation of investigative procedures
- Partner actively with leadership to instill a strong culture of compliance and to integrate compliance into strategic decision-making processes
- Provide compliance reports and updates on a regular basis, and as directed or requested
- Manage reporting, investigations, and resolution of compliance violations and concerns
- Plan and coordinate healthcare and corporate compliance based risk assessments and internal audits/monitoring to proactively identify and address compliance vulnerabilities
- Provide advice on privacy requirements
- JD from an ABA accredited law school with 10 years experience
- Proven experience in pharma/corporate compliance within the biotech, medical device or pharmaceutical industry, including experience within a commercial stage company
- Exceptional strategic thinking, with the ability to build and integrate compliance programs across multiple functions
- Demonstrated ability to work cross-functionally and influence diverse teams and leadership
- Strong knowledge of global regulatory and compliance standards (e.g., FDA, EMA) and healthcare laws
- Excellent communication, analytical and problem-solving skills
- Prefer experience working on a medical or promotional review committee
Self-starter and life-long learner with a strong work ethic and excellent interpersonal skills who
- Is a strong communicator
- 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
- Is eager to take on new challenges
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.
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.
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/
