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  • Posted: Aug 16, 2018
    Deadline: Aug 20, 2018
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    StreSERT is a professional services organisation that offers quality stress-free solutions to corporate organisations. We offer business support and integrated solutions in different areas that ensure business objectives are achieved. Critically, we evaluate issues as they impact your business, and consequently deploy the appropriate skills and competenci...
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    Pharmaceutical Regulatory Affairs Trainee

    Job Ref RA6MC

    Type: Contract
    Duration: 6 months
    Department: Regulatory Affairs, Global Drug Development (RA GDD)
    Reports to: RA Head, (English West Africa)

    Job Description

    • Our client is seeks the services of a Graduate Trainee for a 6 months contract only to support the Regulatory Affairs Unit.

    Job Purpose

    • Regulatory Information Management Systems: DRAGON clean-up activities for migration to the organizations Regulatory Information Management System (RIMS)
    • Support Lifecycle maintenance of registered products
    • Support registration of new products
    • Contributes to the planned roll out of the new Regulatory Information Management System

    Major Accountabilities

    • Support DRAGON clean-up activities
    • Validate data in DRAGON
    • Support the organizations Regulatory Information Management System (RIMS)project work stream in the migration of attributes from DRAGON
    • Regulatory lifecycle maintenance: Support the RA team in maintaining registration of currently approved products and submission/follow up of New Drug Applications

    Ethics and Compliance:

    • Works within Ethics and Compliance policies and ensures those around him/her do the same
    • Works to ensure a diverse and inclusive environment, free from all forms of dis-crimination and harassment

    Key Performance Indicators

    • Validate Data in DRAGON
    • Accurate maintenance of registered products database
    • 100% migration of attributes from DRAGON to the organizations Regulatory Information Management System
    • Achievement of over 95% of DRAGON compliance in updating it with normal country folder Post Distribution Changes (PDCs).

    Requirements

    • Minimum of a First Degree in Pharmacy i.e. B. Pharm
    • Minimum of 1 - 2 years related experience
    • Strong client relationship management and development aptitude
    • Solid interpersonal/presentation skills
    • Proficient in English communication, Prospecting, Analysis skill
    • Must be self-motivated, ready to achieve
    • Proven ability to work independently
    • High level of emotional intelligence
    • Previous experience as a Regulatory Affairs Officer/Intern is an added advantage
    • Computer literacy

    Method of Application

    Applicants should send their CV's to: outsourcing@stresert.com using "PSS" or RA6MC as the subject of mail.

    Note: Qualified candidates will be contacted for interviews immediately.

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