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About the role
Key responsibilities & impact- Leads the Global Labeling strategy function within Global Labeling, Advertising & Promotion.
- Provides labeling guidance / perspective to respective governance bodies.
- Coaches/mentors Global Labeling Sr. Strategists in strategic thinking, technical and leadership attributes.
- Ensures the optimal development / implementation of processes and supports revisions to these processes for continuous improvement.
- Engages cross-functionally with key stakeholders in Global Regulatory Affairs and Safety, Clinical Research, Commercial Development, Medical Affairs and Market Access.
- Establishes a high performing, global culture and organizational model that facilitates the creation and maintenance of scientifically-sound, regulatory-compliant core and local labeling.
- 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.
- Manages the Global Labeling Committee for the product portfolio.
- Ensures labeling adheres to company SOPs and regulatory requirements.
- Represents CSL at industry associations, conferences and health authorities.
Requirements
What you’ll need- 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)
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory experienceglobal labeling strategyregulatory product labeling requirementsrisk minimizationstrategic thinkingproblem solvingdecision making
Soft Skills
leadershipcommunicationorganizational skillsteam playercross-cultural sensitivityrelationship buildinginfluencemotivation
