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Commercial Eyes Recruiting: Senior Manager, Economist (Health Economist)

 

The Opportunity

Commercial Eyes are looking for a permanent full time Senior Manager, Economist (Health Economist) to lead the Market Access and Pricing team. The Senior Manager will be responsible for developing and implementing strategies that ensure the development and growth of the Market Access & Pricing business function.

 

Duties

  • Provide leadership to a team of market access professionals, in accordance with the Vision, Purpose and Values.
  • Build on the existing commercial base of the Market Access & Pricing services functions through the development and implementation of business development initiatives.
  • Building strong interpersonal networks across the life sciences sector, develop key client relationships and proactively seek out new project opportunities.
  • Responsible for the engagement and oversight of third party contractors and suppliers.
  • Oversee the design, implementation and maintenance of systems that deliver operational efficiency.
  • Adhere to the company’s policies and quality management system.
  • Undertake people management processes including recruitment, induction, performance management and coaching in a timely manner and in accordance with established process.

 

Position Requirements

  • Bachelor’s degree in economics, biomedical science, pharmacology, pharmacy or related field.
  • Postgraduate degree in management, health economics, public health or a related field.
  • Vision and energy to lead and grow a consulting / technical professional service business.
  • Outstanding pharmaceutical and / or medical tech industry reputation.
  • Extensive pharmaceutical and / or medical tech industry network (middle & senior).
  • Experience managing functions/departments.
  • Financial acumen and business management aptitude.
  • Demonstrated business development skills.
  • Minimum 10 years relevant management/consulting or industry experience.

 

The Rewards

  • Work for a company consistently delivering excellence.
  • Deliver work that makes a difference to people’s lives through health.
  • Be a member of a team who supports and cares for each other.
  • Be part of an inclusive and diverse working environment.

 

Please note:

  • Commercial Eyes does not accept applications from recruitment agencies.
  • To apply for this role you must be a permanent resident or citizen of Australia. 

 

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

 

If you would like more information, call Simon Higgins on 03 9251 0777.

Posted in Commercial Eyes|Commercialisation Services|Life Sciences Industry|Market Access | Tagged | Comments Off on Commercial Eyes Recruiting: Senior Manager, Economist (Health Economist)

Commercial Eyes Recruiting: Economist (Health Economist)

 

The Opportunity

Commercial Eyes has a unique opportunity for an experienced Economist (Health Economist) to join our Market Access and Pricing team on a full time permanent basis. The Economist will ensure a superior client experience, optimise project outcomes and business revenue, and contribute to the culture and capabilities of the team.

We are looking for an individual who can provide professional development to the less experienced members of the Market Access and Pricing team and support the achievement of individual project and broader business unit budgets.

 

Duties

  • Provide expert consulting services to clients in the key areas of: pricing and reimbursement strategy, feasibility assessment, health economics, statistics, submission development and private/public market pricing in Australia and New Zealand.
  • Work with existing and potential clients in the healthcare sector to anticipate and understand their business needs and identify areas or activities with which CEPL can assist.
  • Translate these conceptual discussions into concrete project proposals which provide a realistic description of the scope of work to be undertaken and a competitive cost estimate.
  • Lead project teams and deliver strategically and technically sound advice, submissions, reports and presentations according to agreed deadlines and client requirements.

 

Position Requirements

  • Minimum undergraduate tertiary qualifications in economics or a life sciences discipline.
  • Post graduate qualifications in health economics, epidemiology, statistics, or health sciences.
  • In-depth working knowledge of the Australian and New Zealand healthcare landscapes, particularly the reimbursement environment, and the ability to use this knowledge to contextualise work.
  • 5 years plus industry experience in an Economist (Health Economist) or Market Access role.
  • Extensive experience in submissions to key Australian and New Zealand reimbursement bodies (PBAC, MSAC, and/or PHARMAC).
  • Experience negotiating with key Government stakeholders and/or pricing experience will be highly regarded.
  • Excellent verbal reasoning and written communication skills.

 

The Rewards

  • Work for a company consistently delivering excellence.
  • Deliver work that makes a difference to people’s lives through health.
  • Be a member of a team who supports and cares for each other.
  • Be part of an inclusive and diverse working environment.

 

Please note:

  • Commercial Eyes does not accept applications from recruitment agencies.
  • To apply for this role you must be a permanent resident or citizen of Australia. 

 

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

If you would like more information, call our People, Learning & Performance department on 03 9251 0777.

Posted in Commercial Eyes|Life Sciences Industry|Market Access|Recruiting | Tagged | Comments Off on Commercial Eyes Recruiting: Economist (Health Economist)

Commercial Eyes Recruiting: Pharmacovigilance Manager

 

The Company

Commercial Eyes is Australia’s leading Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & New Zealand.  We provide a full suite of services through market insight and analysis, registration, reimbursement, patient support, medical information, and pharmacovigilance.  With over 18 years of experience & a team of over 90 employees – what we do – and the consistent excellence with which we do it – sets us apart from other consultancies.

 

The Opportunity

Commercial Eyes has a unique opportunity for an experienced Pharmacovigilance Professional to lead our Drug Safety team. In this role, you will be responsible for the delivery of our client’s patient safety services and related projects across drugs, devices and consumer goods with Australia and New Zealand. This is a challenging and senior role in the organisation. Crucial to the role is the development of strategic plans to drive growth in this key business area.

The Pharmacovigilance Manager must ensure that each Client’s pharmacovigilance service or project is delivered according to best GPV practice and in accordance with contractual agreements. This includes the implementation, maintenance, and improvement of pharmacovigilance systems at Commercial Eyes.

 

Duties

  • Maintain and build successful client and industry relations.
  • Provide strategic advice on pharmacovigilance related matters to clients including ASA annex to EU RMPs including the operationof commitments.
  • Lead internal, external and client pharmacovigilance audits.
  • Oversee day to day operational activities including, Adverse Event reporting, drug safety programs, patient safety monitoring programs across pharmaceuticals, devices, complementary medicines, and consumer goods.
  • Training client’s staff and their third-party partners on safety reporting.
  • Monitoring compliance to project and CEPL pharmacovigilance key performance indicators (KPIs). Undertake RCA and CAPA’s where deviations are identified.
  • Manage the performance and development of the Drug Safety Team.
  • Contribute to the formulation of annual financial objectives and budgets.
  • The incumbent will, in addition, need to comply with Project Specific Responsibilities (PSR) as stipulated in individual Client project(s). Implementing new projects into the PV function as agreed.
  • As a consulting role, responsibility also includes project billing.
  • When acting as QPPV be contactable as per clients requirements, this may include out of business hours requirements.

 

Position Requirements

  • Qualifications in a scientific discipline such as pharmacy, pharmacology, nursing or drug development.
  • 5 years plus industry experience in a Drug Safety Role, preferably with exposure to leadership
  • Knowledge of, and experience with PV compliance audits.
  • Experience with TGA and Medsafe Prescription, Listed and complementary medicines and Devices.
  • Detailed knowledge and understanding of Australian and New Zealand regulatory requirements for safety reporting and the systems and processes needed to ensure compliance.
  • Good knowledge of key overseas regulations relating to pre and post-market drugs, device and consumer goods safety.
  • Highly developed communication, organisational and problem-solving skills.
  • Demonstrated experience managing quality management systems.
  • Demonstrated experience with Microsoft Suite and PV databases.

 

The Rewards

  • Work for a company consistently delivering excellence.
  • Deliver work that makes a difference to people’s lives through health.
  • Be a member of a team who supports and cares for each other.
  • Be part of an inclusive and diverse working environment.

 

Please note:

  • Commercial Eyes does not accept applications from recruitment agencies.
  • To apply for this role you must be a permanent resident or citizen of Australia. 

 

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

 

This role is based in Melbourne.

If you would like more information, call our People, Learning & Performance department on 03 9251 0777.

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Commercial Eyes Recruiting: Senior Consultant, Market Access

 

The Opportunity

This is a new position that reflects the growth of the CEPL business over the last 12-18 months.  The role is available on a full time or part time permanent basis and may be Melbourne or Sydney based, with flexible working conditions. The Senior Consultant has functional leadership responsibilities within the team, working closely with the Associate Director, Market Access to ensure a superior client experience, optimise project outcomes and business revenue and contribute to the culture and capabilities of the team.

The role is not expected to have budgetary or line management responsibilities, however it is anticipated that the successful application will work closely with the Associate Director, Market Access to support the professional development of less experienced members of the Market Access team, and the achievement of individual project and broader business unit budgets.

 

Duties

  • Provide expert consulting services to clients in the key areas of: pricing and reimbursement strategy, feasibility assessment, health economics, statistics, submission development and private/public market pricing in Australia and New Zealand.
  • Work with existing and potential clients in the healthcare sector to anticipate and understand their business needs and identify areas or activities with which CEPL can assist.
  • Translate these conceptual discussions into concrete project proposals which provide a realistic description of the scope of work to be undertaken and a competitive cost estimate.
  • Lead project teams and deliver strategically and technically sound advice, submissions, reports and presentations according to agreed deadlines and client requirements.
  • Proactively promote the CEPL business and build strong professional networks across the healthcare sector.
  • Identify important skills and knowledge gaps in the current CEPL reimbursement and pricing service offeringand implement solutions to these gaps.

 

Position Requirements

  • Minimum undergraduate tertiary qualifications in economics or a life sciences discipline.
  • Post graduate qualifications in health economics, epidemiology, statistics, or health sciences.
  • In-depth working knowledge of the Australian and New Zealand healthcare landscapes, particularly the reimbursement environment, and the ability to use this knowledge to contextualise work.
  • Extensive experience in submissions to key Australian and New Zealand reimbursement bodies (PBAC, MSAC, and/or PHARMAC).
  • Excellent verbal reasoning and written communication skills.
  • Excellent problem solving and project management skills.
  • Proficiency in building and leveraging productive relationships and networks.
  • Highly developed interpersonal skills as they relate to working in a team environment.
  • Previous consultancy experience or a keen interest in the practice of consulting.
  • Experience negotiating with key Government stakeholders and/or pricing experience will be highly regarded.

 

The Rewards

  • Work for a company consistently delivering excellence.
  • Deliver work that makes a difference to people’s lives through health.
  • Be a member of a team who supports and cares for each other.
  • Be part of an inclusive and diverse working environment.

 

Please note:

  • Commercial Eyes does not accept applications from recruitment agencies.
  • To apply for this role you must be a permanent resident or citizen of Australia. 

 

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

If you would like more information, call our People, Learning & Performance department on 03 9251 0777.

Posted in Commercial Eyes|Market Access|Recruiting | Tagged | Comments Off on Commercial Eyes Recruiting: Senior Consultant, Market Access

Commercial Eyes Recruiting: Senior Manager, Regulatory, Quality & Compliance

The Company

Commercial Eyes is Australia’s foremost Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & NZ.  What we do – and the consistent excellence with which we do it – sets us apart from other consultancies.

The Opportunity

Reporting to the Associate Director, the Senior Manager is responsible for operational management of regulatory consultants and other specified consulting and administrative roles (‘the team’) and the assigned project portfolio within the Senior Manager, Regulatory, Quality & Compliance business unit.  The role is also responsible for contributing to the development and operational implementation of strategies that ensure the development and growth of the Senior Manager, Regulatory, Quality & Compliance business unit and achievement of the business unit’s financial and organisational objectives.

Duties

In collaboration with the Associate Director, the Senior Manager is responsible for resource planning and recruitment; staff performance management, professional development and succession planning; design, implementation and maintenance of systems that deliver operational efficiency; adherence to the Company’s policies and quality management system; business promotion and service differentiation; management and development of customer relationships and the encouragement and support of new business initiatives and opportunities.  The Senior Manager will also be responsible for advising on the engagement and oversight of third party contractors specific to Regulatory Services.

The Senior Manager is accountable for building on the existing commercial base of the business unit through the development and implementation of business development initiatives; meeting agreed financial objectives; ensuring teamwork, cross-functionality and operational efficiencies across the business; encouraging value based professional conduct and delivering excellent client service.

Position Requirements

  • Bachelor’s degree in science, pharmacology, pharmacy or related field.
  • Postgraduate degree in management, public health or related field.
  • Minimum 2 years relevant consulting management experience.
  • Minimum 10 years relevant experience in Australian regulatory affairs, preferably in a commercial environment.
  • Vision and energy to lead and grow a consulting / technical professional service function.
  • A leading pharmaceutical and / or medical tech industry reputation.
  • Extensive pharmaceutical and / or medical tech industry network (middle & senior).
  • Financial acumen and business management aptitude.
  • Demonstrated business development skills.
  • Detailed/comprehensive knowledge of TGA legislation, regulations, guidelines and working procedures.
  • Willingness to travel as required.

The Rewards

  • Work for a company consistently delivering excellence.
  • Deliver work that makes a difference to people’s lives through health.
  • Be a member of a team who supports and cares for each other.
  • Be part of an inclusive and diverse working environment.

Please note:

  • Commercial Eyes does not accept applications from recruitment agencies.
  • To apply for this role you must be a permanent resident or citizen of Australia. 

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

This role is based in Melbourne.
If you would like more information, email our People, Learning & Performance department at [email protected]

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Thanks for giving a country kid a go

 

30 years ago, today, on the 14th May 1990, a friend dropped me off at the security gate of Sigma Pharmaceuticals, a pharmaceutical manufacturing plant in Clayton, Melbourne.  It was my first day on the job.  I was a Medical Representative! 

I am not sure I if I was more thrilled to have a job in the pharmaceutical industry (just having a full time job was exciting given the economic climate of the time) or that I was going to be driving home in a new car (ok, it was the car – a brand new Holden Commodore!)

I had learnt about the Medical Representative role in my final year at university during a lecture.  The pharmacology department invited alumni to address final year students and tell us about the sort of jobs that might be available after we graduated.  I had also encountered a very experienced ‘medical rep’, whilst working in my part time job at a swimming pool shop in the eastern suburbs of Melbourne.  His name was Wally Dower and he worked for Astra.  I was very impressed with Wally because he drove a European car – a Volvo.  Wally said that Astra employees drove Volvos because of ‘a special relationship between two leading Swedish companies’.  I thought Astra must be a very impressive company! 

Wally’s job came to my attention when I was loading containers of chlorine into the boot of his car – it was a car boot like no other customer I’d seen – mainly because it seemed to be overflowing with prescription drugs! Samples he called them. There were also boxes of medical brochures, branded pens, writing pads and sticky notes and these other interesting things called ‘call record cards’.  In those days – there were no laptops, mobile phones, not even a pager. Call records were handwritten and regularly checked by Sales Supervisors to ensure they were completed correctly.

Wally explained to me that being a Medical Representative was a fantastic job – it gave you plenty of autonomy; the chance to travel around Melbourne and Victoria; attending interstate and sometimes overseas conferences.  According to Wally, you could meet lots of interesting people working in healthcare including doctors, pharmacists, nurses and tell them fascinating facts about new medicines that would make a difference to their patients.  It was an important job.  It was also your ‘entry ticket’ into the industry and the first step in building a career.

In 1990, a new model of representative was becoming more common on the pharmaceutical scene.  The pharma industry was recruiting biomedical and science graduates, pharmacists, and nurses into sales roles.  A lot of young, well educated, articulate and competitive people, eager to learn and succeed, climb the corporate ladder, travel the world and make a difference.  Well at least, that is how I saw it.

In thinking about this blog, I am reminded about how much was expected of Medical Representatives when I joined the industry.  We met with general practitioners, specialists, hospital medical officers, professors, community pharmacists, practice nurses, directors of pharmacy, therapeutic committees, purchasing managers, the list goes on.  We had to have a thorough understanding of every clinical paper, the ‘APMA’ code of conduct, the Therapeutic Guidelines (for those of us promoting antibiotics) and knowledge of the regulatory system and Pharmaceutical Benefits Scheme. 

I loved learning about the products, all the technical aspects – the pharmacodynamics, pharmacokinetics, the diseases the products were designed to treat – the ‘features and benefits’. I was fascinated how the Australian healthcare system worked – regulation, reimbursement, clinical trials, what the Commonwealth was responsible for and how it differed from the States and Territories.  Wally was right – there was autonomy, the opportunity to meet lots of interesting people and travel all over the state.  He forgot to mention the countless hours of sitting in waiting rooms, having appointments cancelled or being thrown out of pharmacies because ‘Tuesday isn’t rep day’.  To be frank, I did not love the job, there were too many wasted, unproductive hours.  That said, I did get to read a lot of novels, work with, and meet excellent people and did well enough to get an ‘office job’. 

On reflection, the time I spent ‘carrying the bag’, ‘on the road’ was invaluable.  It provided me with an insight into the pharmaceutical and healthcare industry that has provided a better career foundation than I could ever have hoped for.  Most importantly, it gave me a chance to talk to and learn from the medicines industry’s customers every day.  A fundamental to any business’s success.

A big thank you, John Kennedy, for giving a kid from the country a go!

 

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Coronavirus (COVID-19): Information on medicines and medical devices supply in Australia

The Therapeutic Goods Administration (TGA) has consolidated all the COVID‑19 information on their website to assist manufacturers and suppliers with accessing the latest information about the special regulatory requirements for the supply of medicines and devices (including exemptions) in Australia during the pandemic.

We encourage all potential suppliers of therapeutic goods to consult the published guidance to seek up to date information and ensure the supply of medicines and devices is compliant with these requirements. 

 

Navigating the regulatory requirements can be complex. If you are looking to import, advertise or sell a product for the prevention or treatment of COVID-19 and require support, please contact our experienced team at [email protected].

 

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Improved Consumer Medicine Information template

TGA CMI Template

The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI) template that was developed throughout 2019 to reduce complexity and improve readability. Newly registered medicines must use the new template from 1 January 2021, while previously registered medicines must adopt the new format by 30 December 2025.

 

For any enquiries or assistance with CMI formatting, please get in touch with our experienced Regulatory Services team at [email protected]

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Pandemic disruption and a new MA code update; what for patient programs in this new era?

covid19

COVID-19 has taught us that in times of uncertainty, people seek information and reassurance.

With everyone affected by the current pandemic, there are many people around Australia living with chronic and debilitating conditions, impacted by these unprecedented changes and requiring medicines and support for managing their illnesses. People are skipping appointments and missing crucial treatments, whilst communication and reassurance is more necessary than ever to continue keeping vulnerable people safe and well.

Amongst the distractions caused by this novel coronavirus, the long-awaited Medicines Australia (MA) Code Edition 19 was released. But what does this new edition mean for patient programs moving forward, and how can we continue to support patients in a time when they need information more than ever before?

 

  1. Whilst Edition 19 moves towards a ‘principles-based’ approach (and incidentally a lot less pages!) there are still specific requirements MA members are required to uphold surrounding patient support and access programs.
  2. Edition 19 still permits support for patients, albeit usually via third parties who provide patient services. There are a great many wonderful patient support services, and health consumer organisations operating in Australia today. The rapid uptake of technology and communication channels seen since self-isolation measures have been implemented will truly bring lagging demographics into the digital age and complement the many ways in which support and education can be delivered. Edition 19 now treats all channels (digital and traditional) with the same approach, no more distinctions between social or owned media.
  3. A support program is still an activity to help patients get the maximum benefit of their therapy, aimed at improving outcomes via education of appropriate administration of treatment and condition or disease lifestyle management to aid compliance. In recent years patient programs have become more holistic and sophisticated, demonstrating measurable improved outcomes and integrating treatment and lifestyle advice seamlessly. We see these programs as more important now than ever before.
  4. We won’t miss the terminology ‘PFP programs’ which is completely absent from Edition 19. That doesn’t mean familiarisation programs are no more, it means the formulaic requirements including how many patients can participate and the protocols are gone. Now referred to as ‘programs for the provision of medicines at no cost or reduced cost’ they still require a legitimate need and clear clinical rationale, and must withstand public scrutiny with regard to how long they run and how much stock is provided.
  5. Third parties are still paramount in enabling companies to deliver services to patients, providing de-identified data on outcomes that improve compliance, and critically support ongoing Adverse Event monitoring for new medicines. Aligning your Medical Information and Pharmacovigilance requirements internally with the opportunity to provide patient programs will continue to be a pathway to successful access and support programs for patients in need, creating healthier outcomes for all.

 

To find out how patient engagement programs can support your pharmaceutical marketing post Edition 19 and throughout COVID-19 into the future, contact [email protected]

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Hand sanitiser – What do you need to know to supply in Australia?

The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place, it can be difficult to ascertain exactly how product categories have been impacted even day to day.

COVID-19 hand Sanitiser

One of the areas with significant change is hand sanitisers; while washing hands with soap is still considered to be the most effective way to practice good hand hygiene, hand sanitisers can play an important role in keeping hands as free from harmful microorganisms as possible.

Shortages of hand sanitisers are here already, and the inventive, creative and sometimes concerning ways to overcome these potential shortages can pose a risk to the community.

Traditionally, hand sanitizers have been regulated as either ‘cosmetics’ or ‘therapeutic goods’, based on the types of claims made and the ingredients used.

 

To ease the burden of these shortages, from the 28th of March this year the Therapeutic Goods Administration (TGA) has introduced an additional category. Two formulations that were previously regulated as ‘therapeutic goods’ are now excluded from the TGA process requirements for the duration of the COVID-19 pandemic. This was enacted through the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020. It should be clear however that although certain hand sanitisers do not need to be lodged to the TGA, there are still specific requirements in the Determination that must be met before the product can be supplied through this route.

For anyone looking to import or produce hand sanitisers locally it is very important to be aware of the requirements to ensure your product is compliant for supply within Australia. The COVID-19 specific measures implemented by the TGA are creating an ever-evolving complex regulatory environment.

If you need assistance with determining the requirements for supply of hand sanitiser please contact our Regulatory Services team at [email protected]

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