Senior Manager, Ethics and Compliance

Sobi•Waltham, MA

3d•$133,000 - $175,000

About The Position

Essential Responsibilities/Scope of the Job Including, but not limited to the following Partner in the development and/or revision, implementation, communication, and enforcement of the company’s compliance policies and procedures. Manage the company’s transparency reporting program, including federal and state aggregate spend reporting and disclosure laws. Keep apprised of changing and newly enacted legislature and requirements o Regularly reconcile and review company’s reportable transactions Ensure accuracy of required reports/declarations and successful submission by the required deadlines Appropriately educate and train key stakeholders on transparency requirements and process Partner and liaise with global transparency colleagues on overall global transparency process and requirements Serve as point of contact for transparency related questions Manage key elements of the company’s compliance training program including: Administering training and education to ensure employees’ understanding and responsibilities regarding ethics, compliance, and legal matters. Overseeing content creation within the company’s Learning Management System and other software/technology platforms. Tracking, reporting, and ensuring timely completion of assigned trainings Execute key elements of the company’s compliance auditing and monitoring program including: Performing auditing and monitoring to ensure business activities comply with established policies, procedures, and legal requirements Partnering with the business to address detected noncompliance including corrective actions when needed. Tracking and reporting results of the auditing and monitoring activities and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed. Interpreting findings/trends and carrying out corrective action and retraining as needed. Assist cross-functional teams by providing guidance, supporting decision-making, and ensuring operational activities align with regulatory requirements and the company’s ethical standards. Provide guidance and manage key compliance operations related to the HCP/HCO engagement process. Be an ambassador for communication around key compliance topics, resources, and special initiatives. Partner with Global compliance colleagues on key projects and share best practices.

Requirements

5+ years of experience with/in healthcare compliance within the pharmaceutical, biotech, or medical device industries, with strong working knowledge of healthcare laws and regulations
Excellent analytical skills with attention to detail and accuracy
Ability to work in a fast-paced environment and demonstrate a sense of urgency
A proven ability to build strong relationships with various stakeholders at all levels of the organization
Ability to multi-task and prioritize demands
Strong oral, written and communication skills
Must be able to be manage highly confidential information
Highly proficient using Microsoft Word, Excel, and PowerPoint
Ability to travel up to 10% required

Nice To Haves

Working knowledge and previous experience in a compliance operations or project management position desired

Responsibilities

Partner in the development and/or revision, implementation, communication, and enforcement of the company’s compliance policies and procedures.
Manage the company’s transparency reporting program, including federal and state aggregate spend reporting and disclosure laws.
Keep apprised of changing and newly enacted legislature and requirements o Regularly reconcile and review company’s reportable transactions
Ensure accuracy of required reports/declarations and successful submission by the required deadlines
Appropriately educate and train key stakeholders on transparency requirements and process
Partner and liaise with global transparency colleagues on overall global transparency process and requirements
Serve as point of contact for transparency related questions
Manage key elements of the company’s compliance training program including:
Administering training and education to ensure employees’ understanding and responsibilities regarding ethics, compliance, and legal matters.
Overseeing content creation within the company’s Learning Management System and other software/technology platforms.
Tracking, reporting, and ensuring timely completion of assigned trainings
Execute key elements of the company’s compliance auditing and monitoring program including:
Performing auditing and monitoring to ensure business activities comply with established policies, procedures, and legal requirements
Partnering with the business to address detected noncompliance including corrective actions when needed.
Tracking and reporting results of the auditing and monitoring activities and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed.
Interpreting findings/trends and carrying out corrective action and retraining as needed.
Assist cross-functional teams by providing guidance, supporting decision-making, and ensuring operational activities align with regulatory requirements and the company’s ethical standards.
Provide guidance and manage key compliance operations related to the HCP/HCO engagement process.
Be an ambassador for communication around key compliance topics, resources, and special initiatives.
Partner with Global compliance colleagues on key projects and share best practices.

Benefits

Competitive compensation
Generous time off policy
Summer Fridays
Opportunity to broaden your horizons by attending popular conferences
Emphasis on work/life balance
Collaborative and team-oriented environment
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
A competitive 401(k) match to support your financial future.
Tuition and wellness reimbursements to invest in your personal and professional growth.
A comprehensive medical, dental, and vision package to prioritize your health and well-being.
Additional recognition awards to celebrate your achievements.