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New TGA framework to redefine personalised medical devices

A new Therapeutic Goods Administration (TGA) framework will commence on 25th February 2021, changing the definitions of personalised medical devices and the way they are regulated.  

Personalised medical devices are medical devices produced to suit the needs of a particular individual. Previously, personalised medical devices included “Custom-made medical devices” and “Adaptable medical devices”, of which the former was exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).  

The new regulatory framework continues to exempt custom-made devices from inclusion on the ARTG; the primary change being that the scope of products that meet the definition has been reduced by introducing new concepts; “Patient matched medical devices” and “Devices produced using the Medical Device Production System (MDPS)”. Both new types of devices will require inclusion on the ARTG from 25 February 2021.  As a general guide, manufacturing, importing, or supplying more than five (5) of a kind of medical device in a year would make it unlikely for these devices to remain classified as “custom-made medical devices” under the new framework.   

TGA Medical Devices Framework

Patient matched medical devices are medical devices matched to a patient’s anatomy within a specified design envelope using techniques such as scaling of the device and are typically produced in batches through a controlled process. Manufacturers and suppliers with patient-matched medical devices will need to liaise with the TGA on transition arrangements by 25 August 2021 and inclusion applications will need to be submitted prior to 1 November 2024.   

MDPS refers to a validated, multi-component design and production system that can be supplied to healthcare professionals and facilities for the production of specific patient-matched medical devices. Devices produced using MDPS will need to be included on the ARTG and supplied with instructions to enable the safe production of devices that meet their intended purpose.   

In addition to the new definitions in the framework, while custom-made medical devices will continue to be exempt from inclusion on the ARTG, there are new obligations on the information to be supplied with the device, such as record keeping and reporting, and regulator inspection and review, which are required to be met from 25 February 2021.    

 

If you are a manufacturer, supplier or sponsor affected by this change and you need assistance on the next steps, please contact our Regulatory, Quality & Compliance team at [email protected]

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Commercial Eyes acquires Open Sesame Consulting

We are very excited to announce today the acquisition of Open Sesame Consulting by Commercial Eyes. 

Commercial Eyes is Australia’s leading pharmaceutical and medical device commercialisation consultancy.  Commercial Eyes employs over 100 staff and this year celebrates 20 years of operation. Commercial Eyes provides a broad range of commercialisation services in the regulated therapeutics industry, including Regulatory Services, Market Access, Market Insights, Medical Communications, Patient Engagement, Medical Information and Pharmacovigilance.  

Open Sesame Consulting is a leading healthcare consulting company specialising in health economics, funding and reimbursement for medical devices and therapeutic services. Sue John of Open Sesame Consulting has extensive international and local experience over 25 years working for a wide range of medical device companies to secure product reimbursement and support sales with health economics data.   

“We are excited to announce this acquisition and continue to add value to those businesses that Sue John has worked with. As the demand for services in the medical device and diagnostic sector continues to grow for our business, we welcome the opportunity to work closely with Sue to expand our offering and include greater depth in the reimbursement of medical devices. With the increasing convergence of medical technology and overlap in funding sources for some new therapies, this expansion is very logical.   

We have always taken a broad view in supporting clients with all aspects of commercialisation of pharmaceutical and medical devices. Having worked with Sue over many years we understand the requirements of this space and know this will greatly complement our existing offering.”

Andrew Carter said

“I cannot think of a better partner than Commercial Eyes to continue the work I have supported my clients with. I look forward to working closely with the Commercial Eyes team to share my experience and ensure a seamless transition for the clients I have worked with over many years.” 

Sue John said

 

Commercial Eyes is headquartered in Melbourne, with staff in most capital cities around Australia.  

 

For further information please contact Simon Higgins (General Manager Commercialisation Services) on 0478 486 894 or at [email protected]

 

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Season’s greetings from Commercial Eyes

To all our clients, associates and followers. We wish you all the best over the holiday period as well as a safe and happy new year.

Read more about the organisations Commercial Eyes has proudly supported over 2020, and how we have helped make a difference to communities across Australia.

Commercial Eyes is proud to have partnered with Yalari since 2009.

Yalari is a not-for-profit organisation that offers quality, secondary education scholarships at leading Australian boarding schools for Indigenous children from regional, rural and remote communities.

They believe education is the key to generational change and a brighter future for Indigenous Australians and for our nation, as well as deeply committed to the ongoing success of our national program of scholarships, student support and post-school opportunities.

We have sponsored a wonderful student from the Northern Territory, who this year is completing year 10 at Geelong Grammar School.

She returned to her hometown in Darwin as a result of the pandemic, to learn remotely with the support of her teachers.

After restrictions were eased, she arrived back in Melbourne to finished the year, surrounded by friends and an encouraging outlook for 2021.


Commercial Eyes has been a proud supporter of The Smith Family Book & Toy Appeal for the past several years. In 2019 Commercial Eyes contributed by donating over 50 books and toys that helped bring a smile to disadvantaged children.

Sadly, thousands of Australian kids will go without receiving a gift this holiday season simply because their families can’t afford it. The gifts provide children in need to feel a sense of belonging at Christmas, and help the acquire the skill and knowledge they need to build a better future.

Due to COVID-19 we had to donate in a different way, and raised nearly $1,000 thanks to our generous staff.

We are thankful to everyone who donated, and are pleased to be supporting this incredible initiative through online fundraising!


Donations to the Leukaemia Foundation transform fear into hope in miraculous ways by furthering the work of brilliant research scientists who are uncovering life-saving advancements in blood cancer diagnosis and treatment.

Commercial Eyes is honoured to partner with the only national charity dedicated to helping those with leukaemia, lymphoma, myeloma and related blood disorders survive and live a better quality of life.

This year we did something a different, we raised much needed funds and awareness through a virtual company trivia night.

The night was a huge success, and as well as night full of laughs and overly competitive teams, we raised a total of $5,000 from generous staff, family and friends.

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A thriving business in dormant times

 

Do you remember saying – “I catch the train to get to work”?  What about “I’m leaving work in the next half an hour and I’ll pick something up at the supermarket on the way home”. I miss saying those things.

The Commercial Eyes office is in Melbourne’s CBD and is contemporary, full of light and space. Most baristas would cherish working behind our coffee machine and the bowls of fruit and jar of biscuits just seem to fill themselves.

We are in the business of assisting clients bring their medicines, medical devices, and diagnostics to the Australian market. It is a complex task, often difficult to navigate, and requires the contribution of many players. We are just one, and the end goal is to ensure that Australian patients get access to the medicines and healthcare products they need.

Today, our Melbourne office is dormant. It feels lifeless and a bit sad, even the plants look jaded. Only a handful of our nearly 100 employees have been to the office in the past six months. I miss it! Simply because it means that I can’t physically be with the Commercial Eyes team. I think the quid pro quo of needing to be so reliant on our contemporary communication tools, is acknowledging the diminishing effect they have on spontaneity, passion, and generally having fun at work.

That said, our business is thriving! Our technology, systems and databases are doing exactly what they are designed to do. Our staff have mastered them, are working productively, and are connected, to each other and our clients – in some cases more than ever. We are seeing communication advancements and innovation on a regular basis.

Ensuring access to essential medicines and innovative health technology is fundamental to a fair and vibrant society. COVID19 restrictions have had a big impact on where our people do their work; in some ways COVID19 has impacted how we work; most importantly, it underscores the importance of what we do.

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Happy Birthday Commercial Eyes!

 

On this day, 19 years ago (24th September 2001), Commercial Eyes Pty Ltd was created. Today marks the day the company was incorporated (the legal equivalent of creating a new ‘person’).

 

Companies are unique entities. They are a creation of the legal fraternity building on the original idea of a Trust. Some great legal minds have said that the ‘company’ is the most significant legal creation of the post industrial world. This is because a company has no physical being, however, just like a ‘natural person’, a company has legal rights and is regulated by hundreds of laws (e.g. the Corporation Act); it can own stuff, sell stuff, sue and be sued, pay tax, enter into a contract with another party and get a loan; of particular significance, a company, like a real person, can employ people!

We often hear people say that their company is really about the people. Yet, in many cases, the same people’s behaviour and decisions show that they are really much more interested in the ‘products’ that their company makes or sells. They really just need people to make that happen.

However, in a consulting company, there is no ‘product’ without the people. Being a service provider, without the people, Commercial Eyes Pty Ltd would simply be a ‘legal entity’, without any real function, personality or purpose. The people that work for Commercial Eyes really are our business!

 

Thank you to the amazing team and people we have worked with over the years.

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Commercial Eyes Recruiting: Program Coordinator

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

Our Medical Communications and Patient Engagement team are looking for a new team member to join their team as the Program Coordinator. The Program Coordinator is a varied and busy role that would suit a candidate that would like to contribute to improving the health of patients, has exceptional communication skills, and superior time management abilities. With a high degree of initiative and attention to detail, your expertise will ensure the smooth running of our programs and a commitment to providing exceptional experience for all stakeholders.

 

Major Responsibilities

  • Day to day management of assigned program. Manage registrations and respond to queries from Health Care Professionals and patients.
  • Develop and review program materials, SOPs and guides for internal and external use.
  • Produce and update database trackers relevant for program management.
  • Produce reports detailing program metrics.
  • Manage product orders and distribution.
  • Ensure all program activities comply with the relevant legal and compliance requirements.
  • Analyse program data to optimise program customer experience.

 

Education/Experience Required

  • Demonstrated experience managing complex process or high level administration support.
  • Proficient computer skills and in-depth knowledge of Microsoft Office – Word, Outlook, PowerPoint, Excel.
  • Experience managing various stakeholders.
  • Science/Nursing/marketing qualifications would be beneficial.
  • Experience in coordination of programs highly desirable.

 

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: Medical Information Associate

 

The Opportunity

Our Medical Information team are looking for a Medical Information Associate to join their team. The role is based in Melbourne, however applicants from across Australia and New Zealand are welcome to apply as this role offers the flexibility of working from home.

The Medical Information Associate will provide technical and scientific information to healthcare professionals, consumers and internal staff on a wide range of pharmaceutical medicines. The successful candidate will have strong communication skills and will deliver messages in an accurate, precise and professional way.

 

Responsibilities

  • Respond to medical information enquiries from healthcare professionals and patients as well as internal staff regarding relevant client’s products.  Including reporting all potential Adverse Event and Product Complaints.   All enquiries are responded to in accordance with client requirements and country regulations, guidelines and codes of practice. 
  • Support all systems and processes required to respond to medical information enquiries. 
  • Maintaining professional knowledge and accreditation by active participation in continuing medical education activities is encouraged and supported.  Including attending company and client meetings and conferences.
  • You will be required to act as Subject Matter Expert (SME), internally and externally. Liaise with clients to resolve enquirer questions, this may include Medical consulting activities such as review of promotional material, undertake some product alignment and ad hoc project work.  
  • Comply with Project Specific Responsibilities (PSR) as stipulated in individual Client project(s). 

 

Position Requirements

  • BPharm or relevant scientific qualification in disciplines such as Drug Development or Pharmaceutical Sciences.
  • Experience in the provision of drug information to Healthcare professionals and patients (minimum of 1-3 years).  Graduate (Hospital) and experienced Hospital and Community Pharmacists encouraged to apply.
  • Experience in the principles of medical information including demonstrated experience in literature search using Pubmed or Embase, proficient in technical writing, use of medical information databases.
  • Highly developed verbal and written communication, organisational and problem solving skills.
  • Experience with prescription, medical device and/ or complementary medicines.
  • Australian Permanent resident or citizen.

 

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.

 

Graduate (Hospital) and experienced Hospital and Community Pharmacists encouraged to apply.

 

If you would like to apply for the Medical Information associate position, please send your cover letter and resume to: [email protected]

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

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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.

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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.

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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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