Senior Manager, Ethics and Compliance

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $133k - $170k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• 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. • 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 • Strong working knowledge of healthcare laws and regulations • Working knowledge and previous experience in a compliance operations or project management position desired • 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 manage highly confidential information • Highly proficient using Microsoft Word, Excel, and PowerPoint • Ability to travel up to 10% required

🏖️ Benefits

• Competitive compensation for your work • 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