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logo_30387.png ARDERN HEALTHCARE LIMITED
UNITED KINGDOM
Health Care
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  Job Position Job Category Posted On Action
 Medicine & Pharmacy Nurse Health Care 12/18/2018 [ APPLY NOW ]
logo_30387.png ARDERN HEALTHCARE LIMITED
United Arab Emirates
REF NO: H-84645
 
Education :  Bachelors Degree
Experience :  1 - 5 Years

Skills :  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.

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

Responsibilities :  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
APPLICATION
If this role is of interest to you please send a recent copy of your CV to us and a member of the Talent Acquisition team will be in touch.


Description :  Global Product Manager

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. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

Ardern Healthcare Limited is a rapidly growing company that has a great future ahead. To sustain our growth we’re always on the lookout for highly motivated, ambitious and committed individuals to join our highly successful team.

APPLY NOW
 Qa Manager Health Care 12/18/2018 [ APPLY NOW ]
logo_30387.png ARDERN HEALTHCARE LIMITED
United Arab Emirates
REF NO: H-957566
 
Education :  Bachelors Degree
Experience :  1 - 5 Years

Skills :  The key responsibilities for this role are:

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.

Responsibilities :  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
APPLICATION
If this role is of interest to you please upload a recent copy of your CV and a member of the Talent Acquisition team will be in touch.



Description :  Head Of Quality Operations

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 Group consists of five synergistic businesses focused in three areas of global medicine supply: clinical trial, unlicensed and licensed medicines. we provide patient access to our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials.

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.


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 Research Associate Health Care 12/18/2018 [ APPLY NOW ]
logo_30387.png ARDERN HEALTHCARE LIMITED
United Arab Emirates
REF NO: H-74563
 
Education :  Bachelors Degree
Experience :  1 - 5 Years

Skills :  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
APPLICATION
If this role is of interest to you please send a recent copy of your CV to us and a member of the Talent Acquisition team will be in touch.


Responsibilities :  ROLE
The role is responsible for regulatory submissions and maintenance of Global Marketing Authorisations for allocated projects

The Key responsibilities for this role are:

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


Description :  Regulatory Affairs Manager

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. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

Ardern Healthcare Limited is a rapidly growing company that has a great future ahead. To sustain our growth we are always on the lookout for highly motivated, ambitious and committed individuals to join our highly successful team.

APPLY NOW
 Product Development Director Health Care 12/18/2018 [ APPLY NOW ]
logo_30387.png ARDERN HEALTHCARE LIMITED
United Arab Emirates
REF NO: P-846454
 
Education :  Bachelors Degree
Experience :  1 - 5 Years

Skills :  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
APPLICATION
If this role is of interest to you please upload a recent copy of your CV and a member of the Talent Acquisition team will be in touch.

Responsibilities :  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

Description :  Production Operative

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. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

Ardern Healthcare Limited is a rapidly growing company that has a great future ahead. To sustain our growth we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.

APPLY NOW
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