Senior Manager, Ethics and Compliance

🕒 il y a 15 jours

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $133 000 - $170 000 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Sobi - Swedish Orphan Biovitrum AB (publ)

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1991

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sobi - Swedish Orphan Biovitrum AB (publ) est un leader mondial dans la fourniture de traitements innovants pour les personnes atteintes de maladies rares. Spécialisé dans les domaines thérapeutiques tels que l'hématologie et l'immunologie, Sobi s'engage à améliorer l'accès des patients aux médicaments pour des affections rares et débilitantes. Avec un solide pipeline de R&D, l'entreprise poursuit activement de nouvelles thérapies et collabore à l'échelle mondiale pour transformer les soins aux patients dans des domaines tels que l'hémophilie et la thrombocytopénie immune. Sobi s'engage également dans des programmes étendus de durabilité et d'aide humanitaire, démontrant un engagement ferme envers des soins centrés sur le patient et les contributions sociétales.

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.

🎯 Exigences

• 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

🏖️ Avantages

• 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