Global Labelling Lead

• 8-10 years of core global labeling experience
• Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels.
• Demonstrates knowledge and understanding of company Core Data Sheets (CDS) and the dynamics of Labelling Team purpose and objectives.
• Demonstrates ability to understand how updating one section of a label may impact another and to propose recommendations to the Labelling Team.
• Clear and effective written and verbal communication skills.
• Ability to liaise with stakeholders using effective means of communication
• Demonstrates ability to influence and negotiate where necessary, across a highly matrixed team.
• Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
• Ability to interact effectively with all levels/roles of project team members.
• Ability to manage time effectively across all projects, and work on many tasks in parallel.
• Takes ownership and accountability for assigned projects.
• Proven ability to effectively lead project team members in order to resolve issues.
• Consistent ability to foster strong matrix team working relationships. Proven track record of facilitating groups of individuals to work together on creating solutions.
• Proven ability to make sound decisions.
• Interfaces directly with senior management as appropriate on prescribing information content and requirements.
• Independently seeks to resolve problems in a proactive manner.
• Proven understanding of the dynamics and purpose of the companys CDS; experience in reviewing and understanding of implications of the CDS.
• Possesses advanced knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
• Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
• Demonstrates ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
• Demonstrates ability to develop strong and positive working relationships across multiple cultures and within global environment.

Must have:

Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.