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Commercial Eyes Recruiting: Senior Consultant, Regulatory Services

 

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

The Senior Consultant works within the Regulatory Services team to deliver a range of regulatory applications for Australia and New Zealand.  The Senior Consultant manages client projects, working closely with other members of the team, to deliver a superior client experience, optimise project outcomes, and contribute to the culture and capabilities of the team.

 

Duties

  • To primarily support regulatory activities requiring a sound knowledge of the type and quality of clinical and non-clinical evidence necessary to support new medicines registration, related life cycle management and maintenance activities.
  • To provide support to clients on the registration and listing of pharmaceuticals, biologicals and medical devices in Australia.
  • Review, critical evaluation, preparation and submission of regulatory dossiers to the TGA and Medsafe.
  • Prepare literature based submissions, including the preparation of associated overviews and summaries.
  • Assist clients in responding to regulatory agency questions.
  • Assist clients with the maintenance of current registrations and listings.
  • Prepare and submit safety related updates to Product Information documents at varying levels of complexity.
  • Provide strategic advice to clients regarding the Australian and New Zealand regulatory environment.
  • Attend meetings/teleconferences with clients and/or TGA or Medsafe as required.
  • Build strong interpersonal networks across the life sciences sector and draw on these to identify potential short and long-term business opportunities for Commercial Eyes.
  • Liaise with other groups within Commercial Eyes as required.
  • To provide project management support, as required, for all stages of client projects (including proposal writing, budget setting, budget and milestone management, and indirect staff management).
  • Mentor junior staff as required.

 

Position Requirements

  • A minimum of 8 years experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
  • Experience in the review, critical evaluation and presentation of clinical data.
  • Good knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.
  • A degree in science, pharmacy or a related discipline.
  • High level written and oral communication skills.
  • Proven problem solving and project management skills.
  • Reasonable computer literacy.
  • Ability to deal with high level of confidentiality.

 

Preferred

  • Post-graduate qualifications in a relevant discipline.
  • Previous consulting experience.
  • Willingness to travel as required.
  • Experience or aptitude for mentoring and leadership.
  • Experience in technical/medical writing, particularly associated with medical device and pharmaceutical dossier requirements.
  • Regulatory experience in jurisdictions outside of Australia and New Zealand.

 

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 or Sydney.
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, Regulatory Services

 

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 Regulatory Services 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 Regulatory Services 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, call our People, Learning & Performance department on 03 9251 0777.

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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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Commercial Eyes Recruiting: Associate Director, Market Access and Pricing

 

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.  What we do – and the consistent excellence with which we do it – sets us apart from other consultancies.  

 

The Role

The Associate Director is responsible for providing leadership to the Market Access & Pricing Business Unit, achieving the business function’s financial and organisational objectives and representing the business unit internally and externally. Join a great team doing meaningful work that challenges, changes, and demands your best.

 

Duties

  • Developing and implementing strategies that ensure the development and growth of the Market Access & Pricing business function.
  • Responsible for overseeing: 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. 
  • Engagement and oversight of third party contractors and suppliers.
  • Building on the existing commercial base of the Market Access & Pricing service functions through the development and implementation of business development initiatives: for meeting agreed financial objectives, ensuring teamwork, cross-functionality and operational efficiencies across the business, encouraging value based professional conduct and delivering excellent client service.

 

Skills & Experience

  • Bachelor’s degree in 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.

 

This role is based in Melbourne or Sydney.

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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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(NOT) BUSINESS AS USUAL

We live in unprecedented times.

At Commercial Eyes, we focus our efforts on supporting clients in the regulated therapeutics industry get their products to the patients who need them, when they need them. We are conscious of the critical role many of our clients are playing, and will play in the current environment. Indeed, we have had a number of enquiries for direct support in addressing COVID-19 related issues.

Like many companies across Australia and around the world, our teams have quickly transitioned to working remotely.

Our investment in business processes, systems and hardware enabled us to act quickly last week, and our teams have set up seamlessly to be 100% working remotely for all our client requirements. For our work, that means we are relying on technology more than ever to support our clients.

We take matters of public health safety seriously, as well as the potential impact on our employees, business partners and much valued clients.  We will continue to monitor developments and the advice of expert authorities, and our thoughts remain with those affected by the virus.

 

So, for Commercial Eyes, we are well and truly open for business. However, as many of our clients have identified, this is anything but business as usual.

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Brexit – What’s the impact on medicines and medical devices supplied in Australia?

Brexit

 

The long-awaited Brexit is underway with the UK exiting the EU on 31 January 2020

A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition period, with the current regulations for therapeutic goods continuing to apply.

The TGA have recently published guidance for sponsors and the main impact on the supply of medical devices and medicines in Australia will occur after the end of the transition period.

 

Medical devices

The TGA will continue accepting conformity assessment documents issued by UK notified bodies (under MHRA oversight) for medical devices currently on the ARTG, meaning products may continue to be imported and/or supplied in Australia.

The TGA are currently amending legislative instruments to allow new applications for ARTG inclusion to proceed with conformity assessment documents issued by UK notified bodies.

It should be noted that some UK-based device manufacturers are transferring EU certificates from UK notified bodies to EU notified bodies. In this situation sponsors will need to submit variations to update the manufacturers evidence or in some cases submit a device change request if the ARTG entry is impacted.

 

GMP clearances

Sponsors are strongly encouraged to submit extension applications prior to expiry of current GMP clearances for UK manufacturing sites that are supported by MHRA desk-top assessments.

 

Medicines

There is minimal impact to medicines, as Australia and the UK have signed a Mutual Recognition Agreement (MRA) guaranteeing continuity of the existing mutual recognition arrangements when the transition period ends.

Sponsors will need to consider the impact of changes to the supply chain if manufacturing steps such as ‘release for supply’ to the Australian Market are transferred from a UK-based site to EU-based manufacturing sites, to ensure replacement sites are GMP cleared and registered on the ARTG. In this situation, forward planning will be imperative to minimising the impact on medicine supply and avoiding medicine shortages.

 

If you need assistance with assessing the impact of Brexit or navigating your regulatory strategy, please contact our Regulatory Service team at [email protected].

 

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