Sr. Director, Global Labeling Strategy — CSL Behring
NewCHF 68'000 - 103'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 68'000 - 103'000
Role overview
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.
- The Opportunity:
- The Sr.
- Develops global labeling strategies to enable business objectives while optimizing product benefit/risk information for users and prescribers.
What the company offers
- Develops global labeling strategies to enable business objectives while optimizing product benefit/risk information for users and prescribers.
Company and context
- 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.”
- 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).
Additional details
- 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.
- 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.
- Leadership ability with demonstrated problem solving and decision making skills
Notes and original content
- Skills & Experience:
- Strong team p
