Manager, Standards & Governance (fmd)
Job Summary
For our office in Vienna (hybrid working model) we are recruiting for a
Manager Standards and Governance (f/m/d)
About This Role:
As Manager Standards and Governance you will be a vital part of ensuring compliant implementation of global and regional requirements in Austria. Your primary focus will be on driving key compliance processes including training monitoring and governance of events projects and promotional materials. Additionally you will manage Data Privacy and Transparency Reporting fulfilling the role of Information Officer for Biogen this capacity you will ensure that both branded and non-branded local materials adhere to applicable laws regulations codices and aligning with marketing authorizations. This role is crucial in maintaining Biogens commitment to ethical standards and regulatory compliance fitting seamlessly into the broader business structure and contributing to its overall success.
What Youll Do:
Own and drive improvements in Standards & Governance processes to ensure compliant business operations in Austria.
Serve as the primary point of contact for compliance-related questions and execution in line with Biogen policies and procedures.
Support the local Compliance Officer in compliance activities to enable informed business decisions.
Independently implement updated compliance systems and deliver regular compliance trainings.
Leading compliance monitoring activities identifying risks and driving corrective action plans.
Act as the key affiliate contact for Data Privacy matters ensuring effective implementation of initiatives.
Oversee and manage the annual Transparency Reporting process for regulatory compliance.
Provide governance support for engagements and projects ensuring adherence to S&G requirements.
Fulfilling the role of Information Officer for Biogen Austria.
Act as a liaison between Austrian and Swiss affiliates supporting process alignment within the CHAT cluster.
Serve as the primary contact for the Austrian Pharma Association (Pharmig) ensuring strategic collaboration.
Initiate and lead process improvement and governance projects to enhance compliance frameworks.
Represent the Austrian S&G department in the CHAT Governance meeting.
Who You Are:
You are a detail-oriented professional with a passion for compliance and governance. Your ability to connect and collaborate with diverse teams makes you a valuable partner in driving the Standards & Governance agenda. You thrive on designing and implementing systems that ensure compliance and efficiency and you possess a strong commitment to ethical practices. Your proactive approach to problem-solving and continuous improvement sets you apart and your dedication to maintaining high standards is unwavering.
Required Skills:
Minimum Masters Degree in Pharmacy or equivalent (scientific studies).
Minimum 5 years of experience consisting of at least 3 years of relevant experience in Medical Affairs Regulatory Affairs or Compliance in the Pharmaceutical Industry.
Knowledge of the Austrian AMG (Medicinal Products Act) and CoC.
Strong understanding of compliance and governance frameworks.
Preferred Skills:
Prior experience in the field of Compliance.
Familiarity with transparency reporting processes.
Effective communication and collaboration skills.
Minimum annual gross salary of 76.00000 depending on qualification and experience.
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 onto 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.
Required Experience:
Manager
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more