About This Role

The purpose of the GlobalLabelinggroup is to driveBiogen’sregulatorylabelingstrategy and ensure thatlabelingdocuments are of high quality and compliant for the safe and effective use of our products globally.

AsaGlobalLabelingAssociate Director,you wouldbe responsible fordeveloping thelabelingstrategy,leading the development and update of core,EUand USlabelingdocuments and for overseeing implementation at a regionaland locallevel. In this role, you maybe responsible foroverseeing the strategy for other products within your Therapeutic Area

WhatYou’llDo

• Lead timely creation or management of regulatory compliant, competitive and up to date core, EU and US labeling documents throughout the product lifecycle including the Target Label Profile, Core Data Sheet, EU SmPC and USPI

• Lead the cross functional product Labeling Team to reach consensus on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management

• Critically assess the data and propose the labeling strategy to be followed in core, EU and US labeling documents, ensuring alignment with global, regional and local regulatory strategies

• Oversee distribution and tracking of Core Data Sheet updates for assigned products, ensuring compliance is maintained within the Electronic Document Management System and the Regulatory Tracking System

• Understand scientific concepts to critically assess clinical data, enable proactive interactions with appropriate stakeholders, influence the clinical development plan

• Develop and implement strategy for global, EU and US labeling content

• Identify underlying processes and principles for developing product claims representing the risks and opportunities to the project team

• Partner with key stakeholders to ensure product labeling is the most current, accurate, relevant and competitive to inform prescribers and patients

Who YouAre

You will have a passion for strategic regulatory labeling and will be enthusiastic to aid in the evolution of a new labeling department in a growing company. You will havea strong scientific grounding,an excellent eye fordetailand a demonstrated understanding of the importance of labeling governance and compliance.

Required Skills

• Bachelor's degree in a scientific or medically related discipline

• 6+years pharmaceutical/ biotechnology industry regulatory experience, includingglobal, EU andUSregulatory labeling

• Advanced knowledge and understanding of applicable regulations, pharmacology, medicine,pharmacovigilanceand drug development

• Experience in interpretation ofglobal, EU and USregulations, guidelines, policy statements, etc.

• Proven ability to successfully understand regulatory implications of product strategywith regard tothe product label,assessmentand practical management of associated impacts

• Demonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterparts

• Well organized, detail oriented, highly effective written and oral communication skills