Labeling Strategy Director
$128,800–$358,800 year
On-siteDurham, North Carolina, United States
Job Summary
Develop and maintain current knowledge of global labeling regulations to support new product programs across CCDS, US, EU, UK, and Switzerland markets. Lead Target Product Label (TPL) development for early-phase assets and ensure new labeling text meets regulatory requirements for MAAs and related supplements. Interface with project teams to drive labeling assessments against CCDS, prepare Health Authority responses, and communicate strategy, risks, and mitigation plans to the Global Regulatory Science Leadership Team and senior management. Provide coverage on other products during peak periods or absences while facilitating meetings to drive consensus and manage content. This 6-month contract supports IQVIA's mission to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes worldwide.
Required Qualifications
- BA/BS degree in a scientific discipline
- 10+ years of experience in the pharmaceutical industry
- 7+ years of experience in Regulatory labeling
- Strong knowledge of current global regulations, including specifically: e.g. vaccine development regulations and registrations pathways
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.)
- Global labeling experience to provide labeling strategy support across labeling for CCDS, US, EU, Rest of World (ROW), and other major markets
- Proven ability in medical/technical writing
- Experience with TPL work for early development programs and identified life-cycle programs
- Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations
- Ability to lead and manage labeling team meetings, driving strategic discussions and managing content
- Ability to adapt to, and work effectively within, a variety of situations and with various individuals and groups
- Integrity: overriding commitment to integrity and high standards for self and others
- Results orientation
- Strategic orientation: ability to link company and departmental visions with daily work
- Relationship building, teamwork and cooperation: builds and maintains strong working relationships with colleagues
- Must be able to lift 50 lbs
Desired Qualifications
- Master's or PhD
- Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable
- Excellent leadership, communication (verbal and written) and collaboration skills
- Proven ability in medical/technical writing
- Experience with TPL work for early development programs and identified life-cycle programs
- Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations
- Integrity: overriding commitment to integrity and high standards for self and others
- Results orientation
- Strategic orientation: ability to link company and departmental visions with daily work
- Interacts effectively as member of the Regulatory sub-team, communicating effectively on strategies to the Global Labeling Committee and collaborating with business partners, including affiliates and third parties
- Flexibility/adaptability: ability to adapt to, and work effectively within, a variety of situations and with various individuals and groups
- Relationship building, teamwork and cooperation: builds and maintains strong working relationships with colleagues
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