SME â Language Solutions for Market Authorization, Labelling & Market Access
SME â Language Solutions for Market Authorization, Labelling & Market Access
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Job Description
IQVIA Language Solutions seeks a strategic client-facing Associate Director to serve as a Subject Matter Expert (SME) in regulatory and market access translation strategies. This role focuses on designing and deploying compliant fit-for-purpose multilingual solutions for regulatory submissions labelling and market access documentation across global markets.
In addition to leading client engagements and shaping IQVIAs offering strategy this role is accountable for developing standard operating procedures (SOPs) work instructions and internal/external training to ensure quality scalability and regulatory alignment across delivery teams.
Key Responsibilities
Client-Facing Strategic Support
Lead high-level consultations with sponsor clients on multilingual requirements for:
-eCTD/CTD submissions (Modules 15)
- EMA/FDA-compliant labelling (QRD templates blue box SmPC PIL PL)
- Market access and HTA documentation (G-BA NICE AIFA etc.)
Participate in RFP/RFI responses solutioning workshops and bid defenses.
Serve as a trusted advisor to VP-level stakeholders in Regulatory Market Access HEOR and Clinical Operations.
Offering Development & SOP Ownership
Design and formalize SOPs work instructions (WI) and controlled documents to standardize regulatory and access-related translation processes across geographies and therapeutic areas.
Lead the governance and periodic review of documentation to align with updates from EMA FDA Health Canada etc.
Ensure SOPs reflect evolving needs in structured content digital labelling electronic submissions and multilingual packaging.
Training & Capability Building
Develop and deliver role-based training programs for delivery sales project management and linguist teams:
Regulatory writing and translation workflows
Labelling compliance
HTA dossier language requirements
Own the creation and rollout of interactive playbooks job aids and eLearning modules on regulatory translation best practices.
Act as mentor and escalation point for linguists and PMs involved in high-complexity high-risk regulatory or reimbursement projects.
Cross-Functional Leadership
Work closely with Delivery QA and Solutions teams to implement SOPs and quality checks for high-stakes projects.
Influence pricing models scalability assumptions and resource strategy based on regulatory risk volume and market complexity.
Drive internal knowledge sharing and regulatory intelligence gathering across regions and client accounts.
Experience & Qualifications
Required:
10 years in regulatory linguistic or market access roles in life sciences with extensive client-facing experience.
Expertise in regulatory labelling EMA/FDA/HTA submission workflows and language compliance requirements.
Demonstrated experience designing SOPs work instructions or quality frameworks for regulated content.
Proven track record in building and delivering internal and external training programs.
Excellent communication skills with ability to explain regulatory concepts to commercial and operational stakeholders.
Preferred:
Background in CRO MAH regulatory consultancy or global LSP.
Knowledge of ISOand Veeva RIM or eCTD systems.
Fluency in English; other European languages are a plus.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .
At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
Employment Type
Full-Time
