IBL - Medical Associate - (Abbotsford)

Basic qualifications:

You must be in your penultimate year or final year of a Bachelors Degree in a Science related discipline - Biological/Biomedical, Medicine or life sciences preferred, or are currently in your internship year of a Bachelors of Pharmacy.

Preferred qualifications:

You must be in your penultimate year or final year of a Bachelors Degree in a Science related discipline - Biological/Biomedical, Medicine or life sciences preferred, or are currently in your internship year of a Bachelors of Pharmacy.

Details:

Medical Associate - (Abbotsford)

  • 12 month paid role commencing in Jan 2018
  • Gain invaluable industry experience
  • Work in an organisation that makes a difference

We currently have seven exciting and dynamic roles within our Medical Directorate based in our Pharmaceutical head office in Abbotsford, Melbourne. In each role, you will work as an important and valued member gaining valuable experience and insights into the commercial medical environment. You will utilise your scientific knowledge while gaining valuable exposure of the pharmaceutical industry.

Each will provide a great platform for a future career in the industry and build on your medical and professional skills.

We currently have positions available in the following areas:

  • Regulatory Affairs
  • Quality Assurance
  • Medical Information
  • Product Safety
  • Medical Quality and Compliance
  • Investigator Sponsor Studies
  • Scientific Excellence

For a brief description of each of these placements please see below:

What we are looking for?

We're looking for motivated and passionate students who are:

  • In their penultimate year or final year of a Bachelors Degree in a Science related discipline - Biological/Biomedical, Medicine or life sciences preferred, or are currently in your internship year of a Bachelors of Pharmacy.
  • Interested in pursuing a career in the pharmaceutical industry
  • Knowledgeable in regulatory affairs (highly advantageous)
  • Excellent written and verbal communication skills
  • Strong team-work experience
  • Innovative
  • Intellectually curious
  • Ability to review and analyse scientific data
  • High levels of confidentiality

Regulatory Affairs

GSK's Regulatory Affairs team provides the primary link between GSK and the Regulatory Authorities in Australia and New Zealand (TGA/Medsafe). The Regulatory Department supports all activities relating to securing medicines approval in Australia and New Zealand, and maintaining the currency of GSK product licences.

Your role as a Regulatory Affairs Associate will be to provide regulatory support to more senior staff to ensure submission of regulatory applications in accordance with corporate objectives. Projects you may assist with include:

  • Preparation and submission of regulatory applications to the TGA and Medsafe for evaluation, responding to questions from these Regulatory Authorities.
  • Input into formulating the optimum regulatory strategy.
  • Communication of changes to registered details to stakeholders.
  • Management of labelling text to accompany our medicines (e.g. consumer medicine information leaflets, product information).

Quality Assurance

The Quality Team interact with many areas of the Commercial business to ensure that activities are completed right, first time every time. You will be involved in a variety of Quality Management Systems (QMS) related activities throughout the supply chain to ensure the right medicine is available for the right patient at the right time.

Your role will include:

  • To primarily undertake complaints handling activities, including complaints receipt, processing, reporting, issue of site responses to healthcare professionals, and monitoring of spikes or adverse trends for specific products.
  • Develop an understanding of the GSK Quality Management System (QMS).
  • Ensure that local processes and systems they use and interact with, are in full compliance with the GSK QMS GxP, by performing the following:
  • Undertake QMS and SOP training, as required.
  • Promote QMS principles and seek continuous improvement of processes.
  • Prioritise activities per the local Quality Plan.
  • Review local Standard Operating Procedures, (SOPs), and undertake assigned activities, as required.
  • Build strong relationships across Commercial Quality and gain an understanding of key activities with business stakeholders, such as: Customer Support and Logistics, Regulatory Affairs, Medical Information and Pharmacovigilance to meet quality objectives.

Medical Information

GSK's core values of transparency and patient focus are ingrained into the Medical Information role, and are at the heart of what we do. Medical Information interacts with healthcare professionals and patients through the provision of information. Through this interaction, we have become one of the most common points of contact for healthcare professionals and patients alike. You could even say that we are one of the faces of GSK.

As well as providing a high quality Medical Information and Pharmacovigilance service to Australia and New Zealand, this role will require you to draw upon your pre-existing scientific knowledge and challenge you to evaluate clinical data that may be relevant in answering medical enquiries. You will also:

  • Receive enquiries from internal and external customers and provide verbal or written responses which support the appropriate use of our medicines.
  • Ensure responses are timely, accurate, globally consistent, conform to all available product information, and are compliant with legal, regulatory, and GSK requirements.
  • Identify, record, report, and follow-up on adverse events and other Reports of Human Safety Information which have been received spontaneously from internal and external customers.
  • Contribute to Medical Information projects and process improvements which are aligned with the strategic direction of GSK Australia.

Product Safety

The Pharmacovigilance IBL role is one that provides the opportunity to explore the importance of drug safety monitoring and its ongoing relevance, both to GSK, and the pharmaceutical industry in general. Responsibilities will include:

  • Assist with day-to-day Product Safety activities.
  • Comply with relevant policies and procedures on Product Safety.
  • Record, report, and follow-up on adverse events and other Reports of Human Safety Information which have been received from various sources (e.g. spontaneous, literature, third party, named patient).
  • Ensure adverse event reports and other Reports of Human Safety Information are accurate and reported on-time to GSK Central Safety.

Medical Quality and Compliance

The Medical Quality & Compliance team work with a diverse range of teams, both local and international. One day we might be finding the best way to simplify a procedure; the next day we could be performing a check to ensure that only the most up-to-date information has been provided to patients. Another day we could be in costume, creating a video to train others in a new procedure. This team combines a passion for 'doing the right thing' with the opportunity to gain a great insight into the different roles and areas across GSK Australia.

As a Medical Quality and Compliance IBL, you will assist with quality initiatives, including training, reporting, and management monitoring. As well as:

  • Contribute to Medical Quality & Compliance projects and process improvements which are aligned with the strategic direction of GSK Australia.
  • Drive continuous improvement initiatives to ensure optimal efficiency in Medical Affairs.
  • Assist in the implementation of quality management systems across Medical Affairs.
  • Contribute to the Medical Directorate Business Process Review Team.

Investigator Sponsor Studies

Clinical trials sponsored (initiated) by pharmaceutical companies are called "industry sponsored trials". These studies usually involve many sites and many investigators (usually physicians). However, the principal investigator can serve as the sponsor for his or her own study. In such trials the investigator is therefore the "sponsor-investigator".

As an ISS IBL, you will work with the MSL Manager, to develop and implement better ways of working for the management and tracking of Investigator Sponsored Studies across the Medical Directorate (Pharma, Respiratory and Vaccines). You will also:

  • Manage ISS proposals through the GSK ISS Partnering and Opportunity Management System (POMS)
  • Liaise with the Global Accountable Person (GAP), local Supported Studies Accountable Person (SAP) for each study to provide them with support and timely information regarding tracking on eTrack, monitoring, compliance with Clinical Safety and Pharmacovigilance, studies progress and milestone payments, documentation and actions required to maintain compliance.

Scientific Excellence

To provide technical and administrative support for Scientific Excellence activities in Pharmaceuticals. Your key responsibilities will be:

  • To comply with relevant codes, policies, and procedures on promotion and scientific engagement
  • Contribute to the development of promotional, non-promotional, and educational content, materials, and activities through collaboration with other business units
  • Assist with quality initiatives, including training, reporting, and management monitoring
  • Contribute to Scientific Excellence projects and process improvements which are aligned with the strategic direction of GSK Australia

About GSK

GlaxoSmithKline (GSK) is a science-led healthcare company, with a proud history in Australia dating back to 1886. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Preventing and treating disease is challenging and inspiring work. We support, develop and reward the people that make-up our talented workforce. Our diverse business is made up of distinct areas: Pharmaceuticals (including vaccines) and Consumer Healthcare.

Why work for GSK?

  • Gain real work experience that will put you at a competitive advantage to your peers.
  • Work in a highly collaborative, supportive work culture with people who enjoy what they do.
  • Gain additional training outside of your work.
  • Be a part of a community of other IBL students & form real friendships.

How can you apply?

  1. Click Apply Now

  2. In your application you must include your Australian work right status, University name, Bachelor Degree, expected completion date and current stage of degree. Applications without this information will not be considered.

  3. Please note, eligibility criteria states you must be in the penultimate year of your Bachelor degree, in the relevant discipline. Full Australian working rights are required prior to application.

  4. Visit http://au.gsk.com/en-au/careers/students/ to find out more about GSK program.

Any specific questions can be made directly to Sarah Wilde at GSK at [email protected]

Applications close 25 August 2017.

Contact information:

You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


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