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ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
regulatory experienceglobal labeling strategyregulatory product labeling requirementsrisk minimizationstrategic thinkingproblem solvingdecision making
Soft Skills
leadershipcommunicationorganizational skillsteam playercross-cultural sensitivityrelationship buildinginfluencemotivation
Industry Keywords
pharmaceutical industryGlobal Labeling CommitteeSOPsregulatory compliancestakeholder engagementclinical researchcommercial developmentmedical affairsmarket access
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
