We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
- To provide project management support to PharmaLex Ireland Ltd Consultants by liaising with clients to establish their requirements in terms of the technical or regulatory, training or auditing services provided by PharmaLex Ireland Ltd (or additional services as identified).
- To provide support to Consultants by developing client Project Agreements, based on client needs, terms and timelines.
- To provide technical support to PharmaLex Ireland Ltd Consultants as required to support the delivery of client and PharmaLex Ireland Ltd projects.
- To provide technical project management support to assigned PharmaLex Ireland Ltd projects to ensure project delivery within agreed timelines and budgets.
- To manage administration and technical aspects of client applications and subscriptions for the service effectively and efficiently, ensuring a customer focus is maintained.
- To manage preparation and maintenance of technical reports relating to activities of the Help Desk in a manner that ensures traceability to the client and maintenance of the in-house technical reference library.
- To implement the Quality Management System (QMS) in compliance with standards and regulatory requirements applicable to the scope of services offered by PharmaLex Ireland Ltd, e.g. ISO 9001:2008 and EUDRALEX Volume 4, Good Manufacturing Practice Guidelines.
- To keep abreast of changing regulatory standards, industry best practice and emerging trends to provide input to business development and product development opportunities.
- Under the direction of the Business Development Director, participate in business development and marketing initiatives and programmes.
- Contribute to the company publications including the liaising with the in-house Consultants, Associates, industry personnel / sources to gain input and ideas for content.
- To input, as requested, into the annual budgeting process.
- To input into the development of project budgets as required and to manage delivery of all assigned projects within the agreed budget.
- To deal with internal/external customer contacts and resolve queries and problems in an effective and timely manner.
- To liaise with Clients, regulatory authorities and other external parties as required / requested on behalf of clients and/ or on behalf of PharmaLex Ireland Ltd.
- To ensure compliance with all PharmaLex Ireland Ltd company policies and procedures.
- 3rd Level Qualification in a Science subject, qualification in Quality Management a plus
- Ideally 3+ years’ experience in the Pharmaceutical Industry
- High level computer literacy and competency – Microsoft Office
- In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered).
- In-depth understanding of the purpose, objectives and scope of Quality Systems
- Effectively resolving compliance issues
- Working with third parties
- Creation of third party contracts/project agreements
- Working in cross-functional teams
- Contributing to company programmes or projects
- Managing change, influencing stakeholders and delivering results
- Strong Communication Skills – excellent English grammar
- Strong technical writing skills
- Microsoft Office applications
- Project Management Skills
- Strong Interpersonal Skills – when working with PharmaLex Ireland Ltd staff, Associates, clients and external 3rd parties
- Commercial Awareness - Understands the vision and strategy of the Company and takes action to support the collective objectives of the business. Networks appropriately and effectively inside and outside of the Company to build relationships in the interests of the business.
- Change - Resilient; flexible. Identifying improvement opportunities and embracing change, helping to overcome barriers and obstacles.
- Planning & Organising – Analytical; methodical. Establishing a course of action for self to accomplish a specific goal; good organisation and time management / project management skills. Ability to differentiate and prioritise activities in line with business priorities.
- Teamwork - Supportive of colleagues and customers (internal & external) in a manner that respects each individual and contributes to effective team outcomes.
- Drive for Results – Achievement oriented; decisive and action oriented. Setting high standards of performance for self; assuming responsibility and accountability for successfully completing assignments or tasks; self imposing standards of excellence rather than having standards imposed.
- Customer Focus – Conscientious; communicative; socially confident. Making efforts to listen to and to understand the customer (both internal and external); anticipating customer needs; giving high priority to customer satisfaction. Excellent interpersonal skills, builds and establishes rapport with customers, clients and other service providers of PharmaLex Ireland Ltd.
- Information Monitoring and Review – Analytical; creative; methodical. Sets up appropriate and effective monitoring and tracking systems to collect and review relevant data to ensure effective control.
- Problem Solving – Conceptual; creative; analytical. Securing relevant information and identifying key issues and relationships from a base of information: relating and comparing data from different sources as appropriate in order to reach a decision or make recommendations.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.