Job Description
About This Role
The purpose of the Global Labelling group is to drive Biogen’s regulatory labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally.
As the Global Labelling Senior Associate, you will be responsible for:
- Supporting the development and update of artwork components.
- Supporting the development, update and implementation of labelling documents.
What You’ll Do
- Responsible for initiating Regulatory-driven new and updated artwork via Change Management System.
- Record regulatory assessments and ensure Change Management System is appropriately linked to the Regulatory Tracking System.
- Provide oversight and lead Change Management Team meetings with Product Lifecycle & Change Management, Supply chain & Planning.
- Act as intermediary between Regulatory Leads, Affiliates and Partners and Change Management Team to ensure changes to the planned activity and implementation timelines are communicated.
- Review and approval of artwork/mock-ups as required.
- Update Market Requirements Document in Change Management System.
- Contribute to launch team meetings (in partnership with Regulatory Lead) and prepare launch artworks.
- Oversee EMA linguistic review process, for MAA or post-approval, with the translation vendor.
- Audit and compliance support impacting artwork.
Who You Are
You will have a passion for regulatory labelling and artwork implementation, and an excellent eye for detail. You will also have a demonstrated understanding of the importance of labelling governance and compliance.
Qualifications
Required Skills
- Bachelor's degree in a scientific or medically related discipline.
- Proven work experience in the pharmaceutical/ biotechnology industry, preferably including experience within artwork/labelling operations.
- Experience with EDMS and regulatory tracking systems.
- Awareness of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development.
- Demonstrates strong organizational skills, including the ability to prioritize personal workload.
- Ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
- Proficient computer skills with the Microsoft suite of products, primarily Word, Excel, PowerPoint.
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.
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.
