Global Channel Management, Inc.
Global Channel Management is a technology company specializing in recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience across various verticals. GCM understands the challenges companies face in acquiring the skills and experience needed to fill day-to-day functions. Organizations aim to reduce training and labor costs while securing the best talent for the job.
Qualifications
Technical Skill Requirements: - Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling, or a general regulatory background/experience, preferably gained in a country office environment. - Ability to understand, analyze, and incorporate information into local labeling, such as the LPD and patient information, and to logically review impacts on other documentation sections. Preferred Education, Experience, Attributes: - 1 year of pharmaceutical experience desired. - Experience working within corporate systems and procedures. - Excellent project management skills with the ability to plan and prioritize within deadlines. - Clear and effective written and verbal communication skills; fluency in English is essential. This position reports to the locally based Regional Labeling Head, International Labeling Team Lead, or a Senior Manager in the International Labeling Group. It may support other Hub Labeling Managers with ongoing activities. The Hub Labeling Manager (HLM) is primarily responsible for preparing local product documents (LPDs) and associated Local Language Documents (LLDs) for assigned markets, updating labeling documents timely according to SOPs and regulatory requirements. This role acts as a Subject Matter Expert (SME) on local, regional, and multi-country regulatory labeling requirements, participating in intelligence sharing. It also supports the development and use of tools, technologies, and processes to facilitate global label development, submission, and approval in respective countries.
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Technical Skill Requirements: - Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling, or a general regulatory background/experience, preferably gained in a country office environment. - Ability to understand, analyze, and incorporate information into local labeling, such as the LPD and patient information, and to logically review impacts on other documentation sections. Preferred Education, Experience, Attributes: - 1 year of pharmaceutical experience desired. - Experience working within corporate systems and procedures. - Excellent project management skills with the ability to plan and prioritize within deadlines. - Clear and effective written and verbal communication skills; fluency in English is essential. This position reports to the locally based Regional Labeling Head, International Labeling Team Lead, or a Senior Manager in the International Labeling Group. It may support other Hub Labeling Managers with ongoing activities. The Hub Labeling Manager (HLM) is primarily responsible for preparing local product documents (LPDs) and associated Local Language Documents (LLDs) for assigned markets, updating labeling documents timely according to SOPs and regulatory requirements. This role acts as a Subject Matter Expert (SME) on local, regional, and multi-country regulatory labeling requirements, participating in intelligence sharing. It also supports the development and use of tools, technologies, and processes to facilitate global label development, submission, and approval in respective countries.
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