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Details

NPI/Launch Specialist


Reference:KS/AECE-423507 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Our client is an Irish incorporated generic pharmaceutical company who are part of a larger group of pharmaceutical companies. They focus on the development and manufacturing of pharmaceutical products. They use 3rd Party manufacturers all over the world, all holding valid EU GMP and/or FDA approval. They then license out their products to clients globally. The team behind this organisation have significant experience within the European generic industry and today these people are focused on bringing this know-how to Ireland. This is a young, vibrant company that offers excellent opportunities to their employees. They are currently seeking a Launch Specialist with 3 years’ experience in New Product introduction. Must have a strong Supply chain background & generics experience.

Role/Responsibilities:
• Establish and maintain cross-functional teams for each molecule being launched
• Leading and managing the process team to ensure reliable and timely implementation of new product and new SKU’s launches.
• Ensuring interdepartmental information flow, and project status visibility to team members and company management.
• Responsibility for identifying timeline, quality or cost risks and execution recover strategies when required.
• Lead issue resolution in a proactive and positive manner
• Effectively communicate and create a positive experience while achieving the goals with Client, internal stakeholders, external CMO’s and other parties
• Create and update to all stake holders project plans showing the progress for meeting key milestones
• Work with the stakeholders including Quality, Regulatory, R&D, licensing out to ensure alignment and resources allocation to the project.
• Operate with and respect GMP guidelines
• Making introductions with new customers
• Requesting launch Purchase Orders from customers
• Purchase Order validation – as per Agreements (price, quantity, legal entity, lead time, etc)
• Placing Purchase Orders with CMO’s and obtaining confirmation of same
• Providing PO confirmation to customers
• Requesting forecast files to clients
• Co-ordination of generation of SFP and TA and other documentation with QA
• Ensuring Artwork approvals are complete on time
• Establishing detailed launch plans with CMOs.
• Communicating launch plans / status updates to Customers
• Liaising with CMO’s in relation to promise dates (updates / changes / request changes)
• Ensuring master data is created / validated / maintained
• Requesting shipping and batch documentation to CMO and providing it to customer

Qualifications/Experience:
• Degree in Technical, Business administration or Supply Chain.
• 3+ years’ Experience in Launch Management, Project Management or Key Account Management
• Pharmaceutical industry, particularly Generics experience
• Excellent interpersonal and negotiation skills, ability to develop and maintain business relations.
• Strong planning, analytical and problem-solving skills
• Ability to travel approx. 15% of the time
• Languages: main language English, other languages are optional and beneficial

If you would like further Information you can contact the recruiter directly:

Karen Shiel | Tel: +353 (0) 1 5079256




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