Hub Labeling Manager

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

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.

$35/hr

12 MONTHS