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Commercial Eyes Recruiting: Regulatory Associate

Experience it all! Pharma, Med Device, Industry leading companies, broad range of therapeutic areas…

 

 

The role…

The Regulatory Associate is responsible for the preparation and submission of a range of regulatory applications for Australia and New Zealand.  The Associate also supports the delivery of a variety of major projects, working closely with Regulatory Consultants, Senior Consultants and Project Leaders to deliver a superior client experience and optimise project outcomes.

 

Duties include…

  • Regulatory maintenance activities.
  • Assistance in the preparation of regulatory documentation for submission to the TGA and other regulatory agencies.
  • Control and update of internal regulatory templates.
  • Assist with development of proposals.
  • Support to Regulatory Services team.

 

To be successful in this role, you will ideally possess…

  • Undergraduate degree in pharmaceutical sciences or other scientific discipline.
  • 2+ years relevant industry experience.
  • A basic working knowledge of TGA and Medsafe submissions.
  • Reliable and great team member.
  • Proven experience dealing with a high level of confidentiality.
  • Ability to work to deadlines.
  • Attention to detail.
  • Excellent written and spoken communication and interpersonal skills.
  • Demonstrated interest in consulting.
  • An appetite for learning and development.

 

The rewards…..

At Commercial Eyes we work with and support the industry’s best and believe in doing what is right. At Commercial Eyes you will:

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • 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
  • Access workplace flexibility that fits your life and the customer’s needs
  • Join a company that is generous to the community

 

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

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

To apply, please submit your CV and cover letter to [email protected].  If you want to know more information you call Stephanie Gaylard, HR on 61 3 92510777.

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Commercial Eyes Recruiting: Contracts Administrator

Apply your contracts administration skills to this new role and establish systems and processes and then own them!

 

The role…

The Contracts Administrator is responsible for overseeing administration and compliance of client and service agreements, is part of the Business Services team and reports to the Finance Director.

 

Duties…

  • Monitor existing client and service contracts, identify and ensure compliance actions.
  • Design and implement processes to proactively monitor upcoming expiry and renewal of contracts.
  • Support the RFP process and Due Diligence Vendor questionnaires.
  • Design and implement processes to ensure contracts and client proposals adhere to our Quality Management System.
  • Maintain the Agreements Database.
  • Monthly Management Reports.

 

To be successful in this role, you will ideally possess…

  • Tertiary qualifications and/or a combination of study and work experience.
  • Demonstrated experience in contract review and administration.
  • Understanding of relevant legislation, contract administration principles, contract terms and conditions, and procurement processes.
  • Strong computer skills (MS Office and experience managing a contracts database).

 

The rewards…

  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health
  • Access workplace flexibility that fits your life and the customer’s needs
  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment

 

To apply, please submit your CV and cover letter to [email protected]

Please note Commercial Eyes does not accept applications from recruitment agencies.

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Stephanie Gaylard, Human Resources or for a private and confidential discussion on +61392510777.

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commercial eyes recruiting: Regulatory Services Coordinator

If you love being organised, meeting deadlines, and supporting a team to do the same..keep reading!

 

 

The role…

You will be a pivotal part of the team supporting regulatory consultants and associates to provide a superior client experience and to deliver optimal project outcomes.  Duties include;

  • Co-ordinating and ensuring delivery of regulatory submissions to TGA and Medsafe by the specified date, including liaising with third-party suppliers.
  • Assisting the Regulatory Services team with tracking of regulatory projects and tracking and storage of regulator and client communications.
  • Assisting with Quality Management System activities such as document preparation and liaising with Quality Group Delegate(s) for implementation and roll out of SOPs and other related documents.
  • Undertaking project related administrative functions in a timely manner.
  • Managing the business unit’s training database.
  • Ad-hoc administrative tasks as required across the CEPL business.

 

To be successful in this role, you will ideally possess…

  • Excellent systems and administrative skills with strong attention to detail, timeliness and problem-solving abilities.
  • Previous work experience in a medical or regulatory environment
  • Highly capable computer/technical skills – proficient (Word, Outlook, PowerPoint, Excel).
  • Excellent oral and written communication skills
  • Well-presented with professional manner and proven customer service skills
  • Demonstrated experience managing confidential and sensitive information, and sound judgement when interacting with clients and staff.
  • A flexible and positive demeanor being accessible both in terms of availability and personality.

 

The rewards…

  • Work for a company consistently delivering excellence
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • 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

 

To apply, please submit your CV and cover letter to [email protected]

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

Please note to apply for this role you must be a permanent resident or citizen of Australia.

Please note Commercial Eyes does not accept applications from recruitment agencies.

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Human Resources or for a private and confidential discussion on +61392510777.

Posted in Commercial Eyes, Recruiting, Regulatory Services | Tagged , , , | Comments Off on commercial eyes recruiting: Regulatory Services Coordinator

commercial eyes recruiting: research analyst

Apply you research and analysis skills to build a commercial career in the Healthcare industry.

 

The Role…

As the Market Insight Research Analyst you will be responsible for undertaking technical research and data analysis to support the delivery of key insights to Commercial Eyes clients. You will also assist with the development of research hypotheses and research tools and frameworks for analysing and presenting data. As a key contributor to the team you will assist in writing high quality reports and developing presentations for clients.

To be successful in this role, you will ideally possess…..

  • a degree in a life science discipline, business or marketing
  • strong research and analytical skills
  • an understanding of the Australian healthcare market
  • experience in compilation of research reports, data analysis and presentations
  • excellent written and interpersonal communication skills
  • a high attention to detail
  • a continuous improvement mindset
  • strong problem-solving capability
  • excellent collaboration and teamworking skills. 

 

The rewards…..

At Commercial Eyes we work with and support the industry’s best.

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges and demands your best
  • Gain exposure to leading healthcare companies
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives
  • This is a full-time position; however flexible work arrangements may be negotiated.

 

At Commercial Eyes we believe in doing what is right.

  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

 

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

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

 

To apply, please submit your CV and cover letter to [email protected]

Please note Commercial Eyes does not accept applications from recruitment agencies.

Posted in Commercial Eyes, E-Health/Technology, Life Sciences Industry, Market Insight, Recruiting | Tagged , , , | Comments Off on commercial eyes recruiting: research analyst

IWD as HR Manager at Commercial Eyes.

I have a science degree, and I remember being a minority in the lecture theatre during my degree, I was a maths and science teacher and I remember being a minority in the staff room and having to battle the concept that girls aren’t as good at maths and science as boys. Now I am surrounded by women working in science, women leading their business units, and there is no question that girls are great at science and business.

International Women’s Day (March 8) is a global day celebrating the social, economic, cultural and political achievements of women. The day also marks a call to action for accelerating gender parity. I am the HR Manager at Commercial Eyes, and I want to take the opportunity to celebrate the super smart, super successful, women that lead the business and that I get to work with.

The IWD 2019 theme is “Gender Balance”. At Commercial Eyes we work in the Life Sciences Sector, In the report by AusBiotech ‘Australia’s Life Sciences Sector Snapshot 2017’, they found that on average, women represent 50 per cent of the workforce across the entire sector; however female representation decreases as seniority levels increase’. Commercial Eyes is bucking this trend. Instead of female representation dropping as seniority levels increase, at Commercial Eyes it increases! 85% of our management team are women.

I see two key factors that I think have contributed to the strong representation of women in the Commercial Eyes management team.

When Andrew Carter, Managing Director of Commercial Eyes started the business in 2001, he worked with a talent pool of women looking for flexibility that was not at the time readily available in the industry. Incredibly talented women who wanted to balance work and family. – Flexible work practices were essential to Commercial Eyes’ early success and have gone on to become one of the companies’ core values. Today 37% of the CEPL employees work part time or casual, and many more access flexible work practices including altered core hours, and working remotely, to enable them to manage work and life.

They say, ‘success begets success’, at Commercial Eyes the question of women in leadership – is not one that needs to be pondered, because it is happening every day. Having so many women in key business leadership roles, provides role modelling and mentors for others. It’s easier to climb the mountain when you see that someone else has done it. The great thing is that as a consulting firm the female members of our management team engage with people across the sector every day, providing role modelling and inspiration beyond our doors.

It is a pleasure to be working in this environment with such great women.

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International Women’s Day Celebrations

International Women’s Day (March 8) is a global day celebrating the social, economic, cultural and political achievements of women. The day also marks a call to action for accelerating gender parity.

On IWD we celebrated our amazing woman and we considered the role gender imbalance plays in Domestic Violence, and thought about what we can each do for #BalanceforBetter.

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Commercial Eyes Recruiting: Regulatory Services Associate / Consultant

Regulatory Services Associate

Experience it all! Pharma, Med Device, Industry leading companies, broad range of therapeutic areas…

 

The role…

Operating within the Regulatory Services Business Unit this role will involve providing Regulatory Affairs and Quality consulting services to the clients of Commercial Eyes, from routine regulatory submissions to major submissions, such as Category One (1) Applications and New Medicine Applications.

 

To be successful in this role, you will ideally possess…

  • 2+/5+ yrs experience in Aust and NZ regulatory affairs.
  • Knowledge of TGA and Medsafe legislation, regulations, guidelines. 
  • Degree in science or a related discipline (post-grad advantageous)
  • High level written and oral communication skills.
  • Proven problem solving and project management skills.
  • Ability to deal with high level of confidentiality.
  • Previous consulting experience advantageous. 

The rewards…

At Commercial Eyes we work with and support the industry’s best.

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health

 

At Commercial Eyes we believe in doing what is right.

  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

 

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

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

To apply, please submit your CV and cover letter to [email protected].  If you want to know more information call Stephanie Gaylard, HR on 03 92510777.

Posted in Commercial Eyes, Recruiting, Regulatory Services | Tagged , , , | Comments Off on Commercial Eyes Recruiting: Regulatory Services Associate / Consultant

Commercial Eyes Recruiting: Medical Information Associate / Jr Associate

Accelerate your Med Info Career

 

The Role…

This role is a great opportunity to take your career to the next level, through exposure to medical information across a range of companies and products. Join a great team, providing Med Info services on behalf of a range of clients (pharma, OTC, devices, local & global) to enquirers including; healthcare professionals, consumers, and the client’s internal staff.

 

Duties…

  • Receive, assess and respond to medical information enquiries in a timely and compliant manner.
  • Assist in maintenance (creation, review and approval) of standard responses in the medical information database.
  • Respond to customer queries using various medical databases and research strategies, including performing literature reviews.
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures and regulations.
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities.

To be successful in this role, you will ideally possess……….

  • Health Science degree (Pharm, BioMed, PharmSci, etc).
  • 1+ years’ experience in medical information.
  • Knowledge of the principles of medical information communication.
  • Ability to conduct basic literature searches using Pubmed or Embase.
  • Knowledge of prescription, medical device and/ or complementary medicines.
  • Knowledge of ANZ & key overseas regulations in medical information and drug safety reporting.
  • Highly developed verbal and written communication, organisational and problem-solving skills.

The rewards…

At Commercial Eyes we work with and support the industry’s best.

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health

At Commercial Eyes we believe in doing what is right.

  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

 

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

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

To apply, please submit your CV and cover letter to [email protected].  If you want to know more information call Stephanie Gaylard, HR on 61 3 92510777.

Posted in Commercial Eyes, Medical Services, Recruiting | Tagged , , , | Comments Off on Commercial Eyes Recruiting: Medical Information Associate / Jr Associate

Are you ready for the mandatory transition to eCTD for prescription medicines?

Mandatory Transition to eCTD

In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new biological entity, biosimilar and new combination medicine applications; with a proposed implementation by first quarter 2019. The timelines for Stage 2 (other Category 1 applications) and Stage 3 (variations and other types of applications) are 1 October 2019 and 1 July 2020, respectively.

The TGA consultation on the Transition to eCTD only for prescription medicines closes on 4 December 2018 and it is an opportunity to provide feedback on how the staged transition to eCTD will impact your organisation.

The transition to eCTD may seem daunting for companies who have not “taken the plunge”, and with valid reason, as it is not a simple project. Acquiring eCTD software will require considerable planning and resource before you are up and running. Some of the key steps to consider in planning your transition include defining your publishing requirements, investigating software solutions, selecting a vendor, procuring software, preparing IT systems, installing software and training.

Full or partial outsourcing of eCTD publishing is an alternative option which can support your transition to eCTD. Outsourcing can provide a cost and time effective solution for accessing eCTD software and publishing expertise. Partial outsourcing is also an option for increasing publishing capacity and access to local publishing resources in the same time zone can assist with meeting short deadlines.

 

To discuss how Commercial Eyes can assist you with all your eCTD outsourcing needs, contact our Regulatory Services team at [email protected]

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November 2018 PBAC Meeting Agenda

The November 2018 PBAC Meeting is scheduled to conclude today. Here, the Commercial Eyes Market Access team provides an analysis of the meeting agenda, including Sponsors with multiple submissions and the nature of requested listings by type.

 

 

The Commercial Eyes Market Access can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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