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Job Description
This position reports to the locally based Regional Labeling Head, International Labeling Team Lead, or to a Senior Manager in International Labeling Group.
This position may support other Hub Labeling Managers in terms of ongoing activities.
The Hub Labeling manager (HLM) is primarily responsible for preparation of local product documents (LPDs) and their associated Local Language documents (LLDs) for their assigned markets, updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements.
This role will act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence. Additionally this role will support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries.
Key activities include:
- Interaction with other cross functional roles in the delivery and management of labeling text through the appropriate processes and systems
- Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements ; liaise with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
- Development of subject matter expertise for assigned markets or products, and ongoing development of labeling expertise
- Utilisation of analytical skills to review and develop appropriate content for local labeling documents, based on core content, also recording the decisions made
- Working within a framework of internal SOPs and working practices, and external regulatory requirements
- Supporting the use of relevant tools and technologies within the course of the label development and translation process
- Utilisation of regulatory expertise to review, develop and deliver core/local labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
- Engagement in necessary labelling team meetings to discuss any decisions for not making any label updates or discuss any findings of meaningful differences for registration types specific to USPIs, CRP-SmPCs and MRP/DCP-SmPCs as necessary.
- Ensure that decisions taken for labelling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion.
- Ensure all actions taken within role follow applicable SOPs and IGs so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labelling projects via defined procedures and optimal use of systems. Champion and/or participate in continuous improvement efforts related to business practices and tools utilized within role.
- For deliverables in scope, support responses to inquiries from client colleagues in response to inspection activities and regulatory agency questions.
Qualifications
Technical Skill Requirements
- Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling, and/or general regulatory background/experience, potentially gained in a country office environment, is preferred.
- Ability to understand, analyze and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation
Qualifications (i.e., preferred education, experience, attributes)
- 1 year of pharmaceutical experience desired
- Experience of working within corporate systems and procedures
- Excellent project management skills, and ability to plan and prioritise, working within specific deadlines
- Written and verbal communications clear and effective, fluency in English essential
Additional Information
All your information will be kept confidential according to EEO guidelines.
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