Pharmaceutical Labeling Manager

The Fountain Group; Gaithersburg (MD); Remoto; USD 83.000 - 96.000; Tempo pieno

Descrizione del lavoro

The Fountain Group is seeking a Labelling Strategy Associate Director to provide regulatory labeling expertise for complex drug projects. You will lead development and maintenance of Core Product Information and MPI for US/EU markets, guiding cross-functional PLT teams toward compliant and advantageous labeling.

The role requires hands-on labeling experience, 3+ years in regulatory labeling, and strong collaboration across US, Europe, and IG partners.

Competenze

• Hands-on strategic labeling experience.
• 3+ years in regulatory pharmaceutical labeling strategy.
• Ability to hit the ground running on core labeling concepts.
• Experience collaborating with international teams.
• Background in GxP-regulated pharma environment.

Mansioni

• Lead development and maintenance of Core Product Information and MPI.
• Develop labeling strategy aligned with regulatory guidelines.
• Coordinate with GRST/GRET/PLT for CPI, US PI, EU QRD.
• Provide labeling guidance to stakeholders and communicate regulatory updates.
• Mentor peers and contribute to labeling policies and SOPs.
• Ensure labeling processes comply with procedures and GxPs.

Conoscenze

Strategic labeling

Regulatory labeling

Cross-functional collaboration

Formazione

Bachelor’s Degree in Science or related discipline

Strumenti

ERV (Veeva Vault)

Descrizione del lavoro

Pay: $60 - $70/Hour

Duration: 8-9 months

Location: Remote CST or EST

Description

• The Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT).
• This individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned company marketed or pipeline products. The individual contributes to the Development of the labelling group by sharing knowledge and mentoring peers.

Responsibilities

• Ensures that the labelling process is followed through the lifecycle of the product.
• Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
• Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.
• Leads the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
• Leads the development of labelling negotiation strategies, anticipating HA perspectives.
• Provides labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.
• Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations
• Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling
• Ensures appropriate communication across Labelling subfunctions
• Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.
• Leads the development of target labelling documents as appropriate
• Assist in the development of labelling policies, procedures and SOPs

Minimum requirements

• Hands-on Strategic Labeling Experience
• Minimum of 3+ years of direct experience in regulatory pharmaceutical labeling strategy (developing prescribing information, core data sheets, or US/EU package inserts).
• Must be able to hit the ground running without needing training on core labeling concepts.
• Global / International Experience: Experience collaborating with international teams across different time zones (US, Europe, Spain, Sweden, Canada, India) and working with external pharmaceutical partner companies.
• Pharma / Biotech Industry Background: Direct experience within a GxP/regulated pharmaceutical environment.
• Bachelor’s Degree in Science or related discipline

Preferred Background

• Experience in Labelling development and/or maintenance
• Knowledge of major markets Labelling regulations
• Advanced academic training is highly desirable (PharmD, PhD)
• Primary system is ERV (an internal electronic repository based on Veeva Vault).

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