Job Description
About a role
The International Standards and Governance (S&G) for the Biosimilar Business Unit (BBU) is responsible in driving governance and implementation of local business processes at the Affiliate level in close partnership with Compliance and BBU leadership through governance committee. Ensures successful implementation of the Corporate Compliance Program as well as the KPIs that allow for monitoring of success.
Accountabilities
Adherence to compliance policies
- Expert knowledge of Governance & SOPs critical to business compliance and partnership with compliance in planning and executing quarterly monitoring as required and acting as a point of contact for internal and external partner audits.
- External Stakeholders Engagement (ESE) pre-review with business stakeholders and post-review ESE Documentation
- In connection with quarterly monitoring conduct desktop and transactional monitoring of Meals tickets (cap, compliant entry, frequency, etc.) and Events (Post event closeout, proper transfer of value documentation, etc.)
- Ensure compliance messaging brought through /Global communication plans and platforms in partnership with Compliance
Support compliance and business goals
- Participate in implementation of business processes (supporting CO and other respective functions), Global SOP implementation, Record Management, and support Work Instructions & Job Aids design, support new compliance related systems implementation, etc)
- Collaborate cross-functionally and cross geographically to ensure support wherever needed and provide day-to-day advice as to adherence to, and requirements of key Processes and Policy requirements (eg. FMV, etc.)
- Establish and monitor key metrics to promote adherence to SOPs (e.g. material rejection in PRC, rejection of grants, etc.) and develop dashboards for Compliance to use with business stakeholders.
Training Coordinator for BBU
- Establish a training plan (type of trainings and frequency, definition of the audience, and relevant schedule) for S&G and monitor its execution and impact through system-based metrics; establish regular management reporting, and provide re-training as required by compliance.
- Support execution of awareness campaigns (i.e. Speak Up culture, Tone at the Top, etc.)
- Act as the BBU contact person for the Learning Management Systems (BU), and a liaison between BBU and Global.
- Maintain BBU Compliance training program requirements and records (ie COBC)
Data Privacy
- Support Data Privacy office to ensure business compliance with 'The GDPR' and Global Privacy program".
- Actively engage with business to ensure data privacy policies are respected and guardrails applied in business systems and process to ensure compliance.
Qualifications
Requirements
- A minimum of 10 years of experience in a similar role, ideally in the pharmaceutical or biotechnology industries
- Knowledge of Healthcare Compliance Program requirements or experience in other defined governance roles (Audit, GxP, Regulatory Affairs, Business Compliance etc.)
- Data driven and attention to detail
- Experience with policy and procedure drafting and management
- Good understanding of common business processes
- Process management, project/program management skills are a plus
- Excellent and professional communication skills
- Ethical and integrity-driven approach and objectivity
- English fluent
Additional Information
We offer:
- Role in a dynamic and one of the oldest biotechnology company in the world
- Company mission you can be really proud of
- Work with diverse and knowledgeable multinational teams
- Opportunities to learn and grow
- Structured onboarding program
- Customized benefit package
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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
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