Nationwide Recruitment at Ardern Healthcare Limited

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Ardern Healthcare Limited is a rapidly-growing global specialty medical and pharmaceutical company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The company consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. We are recruiting to fill the position below:     Job Title: Global Product Manager Location: Nationwide Role

• The role’s responsibility is to develop and take ownership of partnerships to manage pharmaceutical products and portfolios, across multiple companies and therapeutic areas, to provide health care professionals and patients access to medicines that are not available via the normal commercial licensed route.

Responsibilities The key responsibilities for this role are: Portfolio Development and Planning:

• Working with Business Development and Commercial colleagues across divisions and regions to share and collaborate on product leads
• Oversight of ‘on-demand’, quoted and supplied medicines on an unlicensed basis to drive pricing strategy and identify products of interest for the portfolio (unlicensed or licensing opportunity)
• Contribution to annual business plan and three-year strategic planning
• Provide support to regional commercial division/s as required

Product Management:

• Work with Medical and Account Management teams to understand and evaluate market demand and product usage insights to develop commercial proposals and subsequently determine appropriate product pricing and strategy
• Development of a 3 year strategic demand plan and strategy for assigned products
• Develop a portfolio of marketing tools, necessary to support the plan
• Manage products through stages of product life cycle
• Develop professional relationships with Key Opinion Leaders in areas of core business
• Monitor key financial areas including the recording of monthly sales, expenditure and margins
• Communicate strategies to the field team, encouraging ownership and involvement to ensure delivery of activities
• Attend relevant trade events

Partner Relationship Management:

• Develop and maintain professional relationships with partner companies/suppliers as assigned by the business development team and management
• Manage partner expectations and implement operational processes to ensure requirements of agreements are met
• Comply with partner requirements such as reporting, forecasting and communication
• Attend partner meetings and product training internationally
• Identify opportunities for new business through partner relationships

KOL and Customer Relationship Management:

• Develop and leverage relationships with key customers, KOLs, patient advocacy groups and other key stakeholders relevant to assigned projects
• In collaboration with the field-based team, implement and undertake customer-facing activities required to support partner expectations
• Provide feedback to partners with customer intel as required
• Coordinate and manage customer enquiries regarding the assigned products
• Represent the organisation in negotiations, at conferences, seminars and official occasions

Project Management:

• Collaborate with the business development team to take ownership of assigned products and partnerships
• Act as the key point of contact for assigned partner companies
• Develop business plans and product development plans
• Project manage cross-functional product related activities relating to unlicensed supply, regulatory/reimbursement processes and licensed supply
• Communicate with all involved cross-functional teams and drive product development to achieve growth targets and milestones
• Conduct market analysis and regularly review impact of any market changes
• Communicate any significant market changes to key stakeholders and management team
• Provide regular updates of project progress and milestone achievements

Knowledge and Compliance:

• Maintain a current and comprehensive knowledge of relevant (global and regional) competitors, regulatory and reimbursement pathways in key markets, new products/therapeutics and general medicine advances

Requirements The successful candidate will have the following:

• Extensive experience within pharmaceutical industry, with specific experience in Product Management or a Medical Affairs external-facing role
• Educated to Degree level in Pharmacology, Pharmacy or related Chemistry Degree
• Demonstrable experience in pre-launch product planning and unlicensed medicines supply
• Product and institutional knowledge
• Experience in market and asset analysis relating to medicines
• Experience of operating globally, preferably in multiple countries is desirable
• Excellent interpersonal and demonstrated relationship building skills with internal and external stakeholders
• Experience in Early/Expanded Access Programs is desirable
• Flexible, adaptive and self-motivated
• Ability to travel nationally and internationally (30-40% global travel is required for this role)
• Solid people management experience.

Interested and qualified candidates should:Click here to apply     Job Title: Head Of Quality Operations Location: Nationwide Role

• The role is responsible for ensuring that operations carried out within the Quality team in Ardern Healthcare Limited sites are completed in accordance with the requirements of the regulations and guidelines, Ardern Healthcare Limited Quality Systems and Industry Standards.
• This role will represent the Quality department on assigned project teams in order to provide a consistent approach to the formulation, preparation and execution of quality actions and to also ensure that these activities are implemented in a controlled manner in line with GxP and Ardern Healthcare Limited Global Quality expectations.

Key Responsibilities Quality Operations:

• To perform due diligence checks and ensure suppliers and customers are qualified
• To manage authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate relevant compliance
• To demonstrate the application of activities and provisions in accordance with the Ardern Healthcare Limited licences
• To ensure that any additional requirements imposed on certain products by national law are adhered to
• Manage the Quality release of batches and communicate with relevant QPs
• To ensure appropriate transport requirements and methods for time temperature sensitive medicinal products and hazardous products are used
• To ensure transport equipment is appropriately qualified
• Responsible for the approval of any subcontracted activities which may impact on GxP

Quality Management System (QMS):

• To follow, review and assist in the improvement of the QMS for the Ardern Healthcare Limited
• To ensure customer complaints are dealt with effectively
• To coordinate and promptly action any recall operations for medicinal products and to cooperate with Marketing Authorisation Holders and Competent Authorities
• To be aware of the issues surrounding falsified medicinal products
• To manage the process of development, review and approval of Quality Technical Agreements.

Business Improvement:

• Able to practice continuous improvement and utilizes tools and techniques to solve problems
• Ensure there is a system, procedures and program to manage the validation or qualification of premises, equipment, processes and computerized systems

Personnel:

• To manage Quality personnel, ensuring job descriptions, objectives, personal development plans and appraisals are up-to-date and completed on time
• To ensure that Quality personnel are GxP trained and reflect the same within their duties
• To maintain training records for self and Quality, to ensure training is assessed where required
• Build and manage a high-performing, collaborative team that works in line with the Group’s values at all times.
• Ensure the appropriate level of resource and expertise is in place and that this is structured in the most effective way to deliver the strategy.
• Ensure that team have clear objectives in place and that they understand how these relate to the KPIs and the divisional and Group level strategy.
• Ensure all team members have development plans in place and regularly reviewed.
• Provide regular feedback to direct reports. Proactively address underperformance.
• Ensure effective communication of key messages to the team from across the Group.
• Recognize and celebrate success on a team and individual level.

Requirements The successful candidate will have the following:

• Qualified Person status preferred
• Substantial experience within a Pharmaceutical industry
• Extensive knowledge and experience within Quality and GxP processes
• Computer literate e.g. Word, Excel, PowerPoint, Visio
• Ability to exercise autonomy, good technical and scientific judgment, within the responsibilities defined within this job description
• Experience of developing and implementing operational plans for the areas of responsibility defined within this job description
• Ability to interpret and translate GxP guidelines into effective business strategies and processes
• Extensive people management experience
• Project management skills and able to prioritise work plans and have an ability to perform multiple tasks at one time
• Ability to initiate and maintain working relationships and communication links with the Ardern Healthcare Limited Group, affiliated organisations and third party contractors
• Ability to put across ideas in a clear and concise manner and present a well-structured case to communicate complex information to others
• Proactive, diplomatic, self-motivating, professional with good problem solving, decision making capabilities, influencing and negotiation skills
• Advanced communication and presentation skills
• Have an understanding of the business environment in which Ardern Healthcare Limited operates
• Have an appreciation of the industry sector and current competitors in the market
• Understand the customer base and is aware of customer requirements

Interested and qualified candidates should:Click here to apply     Job Title: Regulatory Affairs Manager Location: Nationwide Role

• The role is responsible for regulatory submissions and maintenance of Global Marketing Authorisations for allocated projects.

Responsibilities Operational:

• Regulatory responsibility for allocated projects on global licensed products within Ardern Healthcare Limited including applications for marketing authorizations in new territories, maintenance of existing licenses, variations to existing licenses, transfer of licenses to Ardern Healthcare Limited
• Responsible for the provision of regulatory support for allocated Managed Access programs
• Responsible to support the development of regulatory strategies and provision of regulatory advice internally.
• Represent Ardern Healthcare Limited professionally in external meetings in a variety of contexts (regulatory authorities, conferences, business meetings).

Departmental:

• Provide coaching and mentoring in specific areas of expertise to junior members of the department
• In case of line management responsibilities: Manage direct line reports and/or external consultants. Provide the necessary training and support to ensure that they are able to fulfil their roles
• Ensure proper filing of regulatory submissions and correspondence either internally or via external contractors
• Create and maintain allocated SOPs for Regulatory Affairs.

Regulatory Intelligence and Compliance:

• Ensure that all regulatory activities comply with current Regulatory Agencies requirements and guidelines
• Assist in establishing and maintaining the Regulatory Intelligence repository for the supply of unlicensed medicines up to date.
• Ensure that Regulatory Intelligence updates are effectively communicated within the company to help ensure regulatory compliance and proper planning
• Proactively build/strengthen contact with external stakeholder (Regulatory Agency, external experts, etc.) to help achieve strategic goals and objectives.

Personal Development:

• Develop and maintain effective external business relationships
• Develop and maintain effective business relationships with key Ardern Healthcare Limited staff
• Participate fully in the Company’s Personal Performance and Development process
• Undertake training and development relevant to the job.
• Adopt safe working practices in line with current Company procedures and to undertake appropriate training in Health and Safety.
• Keep up to date with and implement new legislation as and when required.

Requirements The successful candidate will have the following:

• Bachelor's Degree (or preferably higher degree) in Life Sciences or scientific discipline
• Minimum 4 years’ experience within pharmaceutical industry/CRO. Ideally a minimum of 2 years in a client facing role
• Good knowledge of European Regulatory Affairs with experience in one of the followings: clinical trials, MAA procedures, post marketing maintenance.
• Demonstrate ability to deliver results to the appropriate quality and timelines
• Proven ability to successfully manage regulatory submissions
• Proven ability to provide advice and training in areas of regulatory affairs
• Excellent organizational and project management skills
• Outstanding written, verbal and interpersonal communications skills.
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.

Interested and qualified candidates should:Click here to apply     Job Title: Product and Market Analyst Location: Nationwide Role

• The main responsibility of this role is to analyse potential product and market opportunities, and to collaboratively develop business proposals based on the undertaken analysis.

The key activities and responsibilities for this role are:

• Networking with KOL’s to gain market insights into treatment protocols
• Formulate strategies in collaboration with the following Ardern Healthcare Limited teams: business development, program management, regulatory, medical, supply chain, marketing & sales
• Variety of formats and detail to be developed and communicated, including: initial market assessments, sales and patient forecasts and complehensive business plans
• Development of business plans and commercial proposals in line with Ardern Healthcare Limited corporate guidelines
• Hand-over of the business plan and project to Product Manager/s once the commercial agreement has been signed
• Coordinating and updating new business project activities monthly.
• Prepare business development (BD) presentations and participate in BD meetings
• Maintain up-to-date knowledge of Ardern Healthcare Limited standard operating procedures and policies and ensure compliance at all time.
• Receive brief from project lead, obtain product information / patient data and other relevant information from the partner company
• Research, review and understand the partner company and their challenges (through on-line research and networks)
• Research the product and relevant market/s
• Analyse and interpret the data from clinical trials, treatment guidelines, patient treatment pathways etc.
• Develop knowledge and understanding of the regulatory, healthcare, pharmaceutical and reimbursement environments in the various countries
• Understand the Ardern Healthcare Limited business and capabilities of each division to identify and articulate solutions to offer the partner company

Requirements The successful candidate will have the following:

• Demonstrable experience in pharmaceutical industry, within a new business development, product launch or medical marketing type role
• Educated to Degree level (or equivalent) in a relevant Science field
• Experience in market and asset analysis relating to medicines
• Adaptable and self-motivated, with the ability to work both collaboratively and independently
• Ability to work across various therapeutic areas and various markets, preferably within the European or Latin American regions
• Resourceful with strong analytical skills, with ability to draw conclusions that are data driven and rationale

Skills:

• MS office, in particular power point and excel

Interested and qualified candidates should:Click here to apply     Job Title: Production Operator Location: Nationwide Role The key responsibilities for this role are:

• Ensuring production activities are carried out in an accurate and timely way, ensuring all critical processes are correctly carried out. This shall include documentation and record keeping.
• Maintaining cleanliness and tidiness of the production area.
• Carry out production activities with a high level of accuracy
• Complete documentation / batch records associated to production activities.
• Label reconciliation and line clearance after each job run. Assist in the writing of standard operating procedures for the production activities.
• Attend training to develop skills and knowledge.
• Participate as required in internal audit activities.
• Carry out any other reasonable task that is required by the company.

Requirements The successful candidate will have the following:

• Previous experience in production activities
• High level of attention to detail
• Methodical approach
• Good administrative skills
• Focus on delivering quality product
• Ability to work to deadlines.

Interested and qualified candidates should:Click here to apply   Application Deadline 31st August, 2018.

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