What are the responsibilities and job description for the Hub Labeling Manager position at Global Channel Management, Inc.?
Company Description
Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.
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
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.
Additional Information
$35/hr
12 MONTHS
Salary : $35