Biogen Idec - Cambridge, MA

posted 2 days ago

Full-time - Senior
Cambridge, MA
Chemical Manufacturing

About the position

As a Compliance Officer, you will uphold and promote ethical integrity within Biogen's US business. Your expertise will ensure that our business operations adhere to the highest standards of compliance and regulatory conduct. By developing and delivering comprehensive training programs, you'll be an educational pillar for both new and established employees, fostering a culture of continuous learning and compliance awareness. Your strategic insight will be pivotal in identifying and managing compliance risks. Reporting to the Lead US Compliance Officer, this role is hybrid and based in our Cambridge, MA office, with the understanding that periodic travel is required for training and field monitoring purposes.

Responsibilities

  • Develop and deliver impactful compliance education and awareness programs for US Commercial employees and managers.
  • Communicate emerging trends, new policies, and expectations to the US Commercial organization consistently.
  • Collaborate with business units to identify and prioritize compliance risks and craft solutions to mitigate them effectively.
  • Develop and execute monitoring plans based on identified compliance risks and oversee any necessary remediation.
  • Conduct live compliance monitoring and use findings to discern trends and address compliance risks.
  • Facilitate the implementation of remediation related to compliance investigation findings.
  • Provide support for US commercial brands and functions on compliance issues and initiatives.
  • Assist with US Speakers Bureau compliance and promotional program compliance initiatives.
  • Participate in Internal Audits and help in implementing corrective actions based on audit outcomes.
  • Contribute to critical compliance initiatives and projects.
  • Undertake additional projects or activities as the need arises within the business.

Requirements

  • 12+ years of professional experience, with at least 2 years in a compliance related role in the Life Sciences industry; advanced degree may be substituted for experience, as appropriate.
  • In-depth knowledge of pharmaceutical industry laws, guidelines, and codes.
  • Bachelor's Degree is required; a Juris Doctor (JD) is a plus.
  • Exceptional communication and relationship management abilities.
  • Proven analytical skills with a talent for identifying issues and implementing corrective actions.
  • Strong project management skills with experience working in cross-functional teams.
  • Demonstrated ability to work independently and prioritize tasks effectively.
  • Proven management and leadership skills to maintain compliance in a cost-effective manner.
  • Fluency in English is required, with additional language skills valued.

Nice-to-haves

  • Experience in managing external vendor and supplier relationships.
  • Product launch experience.

Benefits

  • Commitment to building a culture of inclusion and belonging.
  • Opportunities for learning, growth, and expanding skills.
  • A pioneering spirit in a mid-sized biotechnology company.
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