Compliance Manager

Sirtex – Woburn, MA

The Compliance Manager provides oversight and leadership for the compliance function across Sirtex. The role functions within the legal group and reports to the General Counsel & Chief Compliance Officer, and reviews and evaluates compliance issues and concerns within the organization. The Compliance Manager is responsible for the implementation, improvement and management of policies, systems and programs to understand, manage and where possible minimize risks associated with compliance and to do so in a practical, coordinated, and effective manner, in alignment with company and external requirements.

In addition, the Compliance Manager will assist Sirtex in adhering to the broad set of healthcare compliance laws, rules, and regulations that pertain to the prevention of fraud and abuse in the development, distribution, sale and marketing of regulated products, including medical devices, and which includes developing, implementing and maintaining the Sirtex Compliance Program to ensure compliance with these requirements.

The Compliance Manager ensures that all Sirtex compliance activities are undertaken in accordance with the highest ethical standards and in compliance with the laws, regulations, codes of conduct and other relevant guiding practices in which Sirtex and its subsidiary entities operate.

Responsibilities/ Authorities:

  • Establish and maintain the companys Compliance programs for designated compliance risk areas, including bribery & corruption and employee conduct, ensuring compliance with applicable legislation and regulations
  • Ensure Compliance training is in accordance with business needs
  • Provide clear and concise communications regarding Compliance requirements and expectations to drive consistency across global sites
  • Provide monthly reports to Sirtex Management, as well as more-detailed reports, as required, to ensure that Management is appropriately informed on Sirtexs compliance status
  • Develop audit tools to be used to ensure program consistency and improvement across the organization
  • Develop and maintain expert knowledge of evolving and existing requirements and regulations around Compliance risks, and provide direction on anticipated, future requirements
  • Develop and maintain a suite of metrics to facilitate continuous improvement in Corporate Compliance performance
  • Support SIR-Spheres product and future products by providing substantive advice to the Sales, Marketing, Medical Affairs and other functional teams concerning compliance issues across the jurisdictions in which Sirtex currently, or plans to, operate, in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement and interactions with healthcare professionals
  • Resolve routine and complex compliance matters and manage them appropriately
  • General:

  • Work effectively cross functionally and build strong relationships both within Sirtex and with relevant external regulatory bodies
  • Employee will provide support in other areas as assigned by his/her supervisor
  • Educational Prerequisites and Skill Requirements

  • Bachelors degree
  • Minimum 7 years experience in compliance field required, including exposure to global, multi-national pharmaceutical or medical technology
  • Familiarity with a global environment and compliance issues
  • Detailed, working knowledge of the healthcare compliance landscape
  • Strong verbal, written, analytical, and persuasive skills and ability to interact effectively with all levels
  • Highly organised, exhibiting meticulous attention to detail, excellent record keeping
  • Exceptional time management, communication, presentation and influencing skills
  • Experience in people leadership and development
  • Sound conflict resolution and negotiation skills
  • Strong interpersonal skills, an energetic, proactive, flexible individual who can work independently and as a team player, with high integrity and ethics in all dealings
  • Ability to see the big picture and understand what is best for organization long term
  • Open to learning, enthused by the day and resilient with a sense of humor
  • Training Requirements

  • Undergo all formal training, as may be directed from time-to-time
  • Observe and comply with all Sirtex corporate policies
  • Work within, and ensure adherence to quality system procedures, work instructions and other quality system requirements
  • Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements.

    WHAT YOU CAN EXPECT FROM SIRTEX:

    If you have the right skills and experience and want to work for a company making a real difference to the quality of peoples lives, Sirtex will offer the right candidate:

  • Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
  • A working culture of respect, diversity and performance to help facilitate an inclusive culture
  • Attractive compensation and benefit packages which are practical, robust, fair and equitable
  • A place to grow through career development and training opportunities
  • Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world
  • HOW TO APPLY:

    To apply, please email your cover letter and resum to Human Resources at recruitment@sirtex.com.

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