Labeling Strategy Director

IQVIA•Durham, NC

4d•Onsite

About The Position

IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs to be based in the US. This role is intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for new products for global markets, including the United States, European Union, the United Kingdom and Switzerland. This is a 6 month contract with the potential for extension.

Requirements

BA/BS degree in a scientific discipline required, Master’s or PhD preferred.
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.)

Nice To Haves

Experience facilitating meetings and driving consensus and results.
Excellent leadership, communication (verbal and written) and collaboration skills.
Proven ability in medical/technical writing.
Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable.
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.

Responsibilities

Global labeling experience to provide labeling strategy support across labeling for CCDS, US, EU, Rest of World (ROW), and other major markets.
Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
Lead the Target Product Label (TPL) development for early-phase assets.
Develop labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments.
Ensure that new labeling text meets regulatory labeling requirements.
Support the project teams with Rest of World ROW labeling assessments against the CCDS and preparation of Health Authority (HA) responses.
Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
Effectively communicate the regulatory labeling strategy, risks, mitigation strategies and overall plans to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant.
Provide input to the end-to-end labeling process.
Ability to lead and manage labeling team meetings, driving strategic discussions and managing content.
Provide coverage, as needed, on other products during peak periods or during absences of other team members.