The Opportunity
The Sr. Director, Head of Global Labeling Strategy leads the Global Labeling strategy function within Global Labeling, Advertising & Promotion and has overall responsibility for the worldwide labeling strategy portfolio within CSL.
In this leadership position, the Head of Global Labeling Strategy provides labeling guidance / perspective to respective governance bodies, advocates for CSL positions within the Development Labeling Strategy.
Coaches/mentors Global Labeling Sr. Strategists in strategic thinking, technical and leadership attributes. As the business owner for the labeling strategy review/approval process, the Head of Global Labeling Strategy ensures the optimal development / implementation of processes and supports revisions to these processes to enable continuous improvement.
Due to the global nature of the position, the Head of Global Labeling Strategy engages cross-functionally with key stakeholders in Global Regulatory Affairs and Safety, Clinical Research, Commercial Development, Medical Affairs and Market Access to ensure business critical objectives are met and scientific, regulatory compliant labeling is provided to Health Care Professionals.
The Role
Works closely with the TA Heads, GRA GRS to maintain an effective, globally-minded, Global Regulatory Affairs and Safety organization that is focused on utilizing creative problem-solving skills, can clearly articulate the science / regulatory perspective to stakeholders, and contributes to the overall TA Strategy for each TA.
Establishes a high performing, global culture and organizational model that facilitates the creation and maintenance of scientifically-sound, regulatory-compliant core and local labeling for CSL’s product portfolio.
Manages a team of global labeling strategy professionals at CSL facilities, such as in the USA, Switzerland and Australia and mentors the department in CSL's Leadership behaviors and the “CSL Way.”
Develops global labeling strategies to enable business objectives while optimizing product benefit/risk information for users and prescribers.
Contributes and directs strategic initiatives targeting business, regulatory requirements and clinical needs related to product labeling.
Provides expert input regarding labeling/labeling processes with local affiliates and third party distributors.
Manages the Global Labeling Committee for the product portfolio.
Coordinates activities including participation in internal and external labeling-related audits, ensuring labeling adheres to company SOPs and regulatory requirements.
Represents CSL at industry associations, conferences and health authorities to promote the CSL strategic labeling perspective. Utilizing this network, brings 'best in class' labeling strategy approaches and regulatory intelligence to CSL and is abreast of current global labeling trends.
As needed, represents Global Labeling at the Global Safety Committee (GSC).
Ensures processes supporting generation and modification of Development Company Core Data Sheets (dCCDS) and Company Core Data Sheets (CCDS) enable timely communication and roll-out of information about changes to core product labels, in particular changes related to safety information.
Skills & Experience
At least 10 years of regulatory experience, with focus on global labeling strategy, and previous managerial experience (7+ years). Overall pharmaceutical /industry experience should exceed 15 years.
Broad knowledge of and experience with regulatory product labeling requirements and risk minimization
Experience working in a complex and matrix environment is required
Demonstrated experience in working with multiple stakeholders.
Demonstrated ability to lead, influence and motivate a cross-cultural team
Able to think strategically and develop innovative global labeling strategies
Leadership ability with demonstrated problem solving and decision making skills
Strong team player with the communication and organizational skills to interact seamlessly both internally and externally on strategic and scientific matters.
Effective communication skills, specifically related to complex concepts to a variety of audiences.
Ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
Proven ability to build and lead effective, well integrated, collaborative teams, empowers others.
Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters
Fluency in English (verbal and written)
#J-18808-Ljbffr