Job Title: US Compliance Officer
Cycle Company: Cycle Pharmaceuticals, Inc
Location: Boston, Massachusetts, USA.
Featured as one of “The Sunday Times 10 Tech Track Ones to Watch 2020,” we are looking to recruit a healthcare/life sciences/pharmaceutical compliance professional into our rapidly expanding US office to fill the Compliance Officer position.
This is an exciting opportunity for an experienced, mission-driven compliance professional with an entrepreneurial mindset and growing executive presence to join Cycle’s US leadership team in a strategic, compliance role. Working directly with Cycle’s UK based Group General Counsel and Head of Legal, Compliance Officer will provide superior overall compliance guidance, advice and support to the US senior management team and wider operational functions in all areas relating to Cycle’s compliance program, including general corporate, healthcare, pharmaceutical and privacy compliance matters.
Compliance Officer will report to Head of Legal, based in the UK, and coordinate their activities with the US VP of Operations, as well as working daily alongside the US management team, including the US Legal Counsel and Medical Affairs Director. As Compliance Officer will play a role in a range of operational and strategic issues relative to Cycle’s expansion, this position offers the successful candidate an opportunity to be integrally involved in the company’s growth.
- Develops the existing annual compliance program work plan and risk assessment, identifying areas of risk and anticipated government audit targets;
- Conducts monitoring for each product’s commercial and medical activities (alongside the VP Operations and Director of Medical Affairs)
- Updates and implements policies and procedures to achieve the goals of the compliance program, in addition to promoting adherence to federal, state, and local laws and regulations;
- Designs compliance training (and administers such training where appropriate)
- Conducts internal compliance audits and reports findings to the compliance committee;
- Issues briefing documents to the Board of Directors, and the compliance committee regarding legal and regulatory updates and/or relevant government health care program changes;
- Oversees the development and daily functions of the compliance hotline;
- Conducts investigations of potential compliance violations received through the compliance hotline or otherwise;
- Collaborates and consults with the Group General Counsel, Head of Legal and US Legal Counsel on any research, compliance, legal, and other relevant matters;
- Works with medical, legal and other business units, departments, and appropriate committees to ensure the organization has and maintains appropriate HIPAA privacy and confidentiality consents, authorization forms, information, notices and materials reflecting current requirements.
- Maintains current knowledge of applicable federal and state privacy laws and accreditation standards, and monitors advancements in information privacy technologies to ensure organizational adaptation and compliance
- Stays abreast of relevant new US and global legal compliance and privacy developments
- Advise internal stakeholders of how new rulings, regulations and opinions may impact Cycle’s business; provide practical guidance to prevent or minimize compliance risk;
- Liaise with and support colleagues across all of Cycle’s various business and scientific units, in a team-like manner, as business needs dictate;
- Manage and respond to requests for compliance advice across all levels of the US organization;
- Engage outside counsel for expertise or additional compliance support as necessary where budget allows.
Qualifications and Skills
- JD from accredited U.S. law school;
- Passionate about life sciences compliance and privacy, and have a comprehensive life sciences compliance and privacy background gained in private practice and/or in house;At least 2 years as a compliance officer or similar risk management role operating in a global capacity with expertise in FCPA and similar international anticorruption/antibribery laws, GDPR, HIPAA and other international privacy laws, anti-kickback and global trade compliance laws;
- Demonstrated knowledge of all compliance issues related to life cycle of drug development and distribution;
- Able to provide analytical, practical and pragmatic compliance advice and guidance to support goals of business units;
- Flexible, collaborative colleague; sense of humor; thrives in fast-paced environment
- Outstanding interpersonal and communication skills to establish and maintain excellent relationships with all levels of employees and external business associates;
- Impeccable ethics and integrity.
- Certifications in Compliance (CHC), Privacy (CHPC) or (CIPP/CIPM), and Compliance and Ethics (CCEP)
- Experience in conducting or managing audits and/or investigations
Working Conditions & Environment
The role will be based in our new Westwood, MA office but with some travel to attend meetings both nationally and internationally required. However, as our new office is finalised and with the ongoing current COVID-19 situation, we will enable you to work flexibly from home for all or part of the week, and other travel will be limited until the wider situation stabilises.
Employee Benefits at Cycle Pharmaceuticals
In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will be part of the Cycle ‘family’ and enjoy all the benefits that brings:
- Competitive salary based on experience
- Performance based bonus
- Opportunity to join a fast growing and ambitious business
- 100% Employer Paid membership of the Company Group Health Insurance
- Contributory 401k Plan with company match
- Generous paid time off (PTO)
Applicants must be eligible to work in the US and have the ability to travel when appropriate.
Applications: please send your CV and a cover letter to email@example.com
Cycle Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.