Jobs at Gilead Pharmaceutical

Responsibilities

• Provide quotations to clients
• Handle Purchase Order/invoicing/credit note
• Handle receipt of stock to system.
• Filing of incoming and outgoing invoices
• Answer to queries from customer/supplier
• Assist in packing/labeling of stock
• Assist to pack stock according to invoice to customer
• Feedback on replenishment of stock to facilitate ordering of new stock.
• Co-ordinate between pick-up and delivery or orders.
• Any other duties as assigned by immediate superior

Requirements

• HND/B.Sc/BA with at least 3 years' relevant experience in a similar role
• Knowledge of medical / pharmaceutical products will be an advantage
• Good communication and interpersonal skills
• Able to work independently with minimal supervision
• Good attitude and willing to learn.

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Job Summary

• Responsible for assisting the team with regulatory filings as necessary to market company products.
• This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.

Duties and Responsibilities

• Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.
• Respond to requests from foreign government and/or distributors as needed
• Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
• Evaluate risk of proposed regulatory strategies; may offer solutions
• Reviews proposed labeling for compliance with applicable global regulations
• Writes and manages the development of package inserts
• Reviews and evaluates promotion and advertising material for compliance with applicable regulations
• Reviews proposed product changes for impact on regulatory status of the product
• Communicates with regulatory and governmental agencies with supervision

Education/Experience Requirements

• Bachelor's Degree required; concentration in Life Sciences, Technical/Engineering or related field, preferred
• A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
• Regulatory Affairs Certification
• A combination of education and experience may be considered.

Areas of Competence:

• Strong writing, communication, and interpersonal skills
• Strong attention to detail; ability to multi-task and balance competing priorities
• Knowledge of overall business environment and the marketplace
• Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed based on functional area
• Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
• Ability to identify risk in Regulatory strategies
• Strong problem solving skills
• Effective negotiating skills
• Basic computer skills, including Microsoft Office Suite