Compliance Officer, US

Posted 8 Days Ago
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Cambridge, MA
Senior level
Biotech
The Role
As a Compliance Officer at Biogen, you will ensure adherence to compliance and regulatory standards, develop training programs, manage compliance risks, conduct monitoring, and participate in audits. You'll collaborate with business units and support commercial brands on compliance issues.
Summary Generated by Built In

Job Description

About This Role: 

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.

 What You’ll Do:

  • 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.

Qualifications

Who You Are:

You are someone who thrives in a matrix environment, balancing independence with a collaborative spirit. Your communication skills are impeccable, allowing you to build strong relationships across various functions. You have a knack for analyzing complex situations, identifying root causes, and implementing effective solutions. Your leadership capabilities enable you to manage compliance efforts with cost-effectiveness and efficiency. The prospect of juggling multiple demands while maintaining a business-focused and process-oriented mindset excites you. You resonate with the values of integrity and ethical conduct, making you an ideal candidate to champion compliance within a forward-thinking organization.

Required Skills:

  • 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.

Preferred Skills:

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

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.


The Company
HQ: Cambridge, MA
9,575 Employees
On-site Workplace

What We Do

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.

Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.

With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

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