Global Labelling Senior Associate
Global Labelling Senior Associate
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Salary Not Disclosed
1 Vacancy
Job Description
About This Role
The purpose of the Global Labelling group is to drive Biogens 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
- Development and update of global EU and US labelling documents including EMA linguistic review
What Youll Do
- Responsible for initiating Regulatorydriven 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/mockups 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 postapproval 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
- Bachelors 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
