Resume
Careers in the Industry
- Sales and Marketing
- Clinical Research
- Data Management
- Drug Safety / Pharmacovigalence
- Health Economics
- Medical Information
- Regulatory Affairs
- Study Coordinators
- Disclaimer
Sales Representatives are at the coalface, communicating information about company products to the medical community, which could include GPs, specialist nursing staff and pharmacists. The role involves covering a large geographic area, so travel will generally be extensive. You may spend considerable time waiting to see your appointment so you need to be patient and persuasive. It is a results driven and target focused role and will involve a lot of planning and reporting on deliverance of objectives and targets. You will need to gain a thorough understanding of products, therapeutic areas and competitor information and abide by the code of conduct.
Qualification requirements include a life science or related degree, be outgoing, have strong interpersonal, communication and presentation skills as well as be self-motivated.
Before you can move into a marketing role, you generally need to gain some experience as a sales representative. In addition to this, it is worth considering undertaking postgraduate studies within the marketing commerce area to further support your understanding and application. A role in marketing could involve activities such as product launch strategies and evaluating new products for market potential.
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The Clinical Research Department is involved in the conduct of clinical trials. The trials carried out in the development of a product can be divided into four phases, from Phase I the first time the product is used in humans to Phase IV trials which are conducted once the product has marketing approval. The department generally consists of CRAs, a CRM (Manager) and may have Project Managers and Clinical Trial Assistants.
A Clinical Research Associate (CRA) can also be known as a Study Monitor, Clinical Research Scientist, or Site Manager. A CRA is involved in activities such as selecting suitable investigators, initiating the clinical trial at the sites, monitoring the sites, the progress of the study and closing the site and or study. A CRA’s role is to ensure that the trial is in compliance with Good Clinical Practice (ICH GCP), the applicable regulations and the protocol. This involves lots of checking documentation, checking medical records against the Case Record Form (CRF), assessing sites, presenting and training study staff on the study conduct and having a strong understanding of ICH GCP, regulations and protocols. For further details on ICH/GCP, please refer to list of useful websites in the industry news section.
CRAs in Australia are not frequently exposed to the design of protocols, CRFs, international project management or report writing as these activities are usually generated in the overseas head office. As an entry level/ junior CRA you would predominantly be involved in the monitoring of studies and source data verification. This can mean traveling up to 60% of your working week throughout Australia and New Zealand, which can mean long days with early flights and late returns. Once you gain more experience, you could be given additional responsibilities, such as site or study management, project coordination, budgeting, timeline estimation and presenting at Investigators Meetings. Once you reach a Senior CRA level or Project Leader level your time monitoring will decrease as the additional responsibilities such as those described above fill your day.
Entry into clinical research can be achieved through a Clinical Trial Assistant (CTA) position. A Clinical Trial Assistant (CTA) role is generally highly administrative and involves assisting the CRA with study documentation, such as preparation of site files for study commencement, or tracking documentation such as data queries throughout the study period. It provides solid training for a CRA role, by developing your understanding of clinical trials, the CRA role and appropriate guidelines. Most companies expect you to remain a CTA for approximately 1 year before you would be promoted to a CRA. This will depend on your skills and developments within the role.
Essential qualifications are a life science related degree or nursing qualifications as a minimum, with some work experience. Knowledge of the clinical trial process is generally essential, with study coordinator / trial experience considered favourable. Therapeutic knowledge is also an important factor. The CRA role involves interacting with external customers, such as hospital specialists, GPs, nurses, scientists, pharmacists and administrative staff. You need to have strong interpersonal, negotiation, organisational skills and attention to detail. You need to be flexible, be able to multi task. Travel may include overnight trips
Once you have gained experience in clinical you may choose to move into a clinical training role, quality assurance role, business development/marketing or progress through to project management and management roles.
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Data Managements’ main function is to ensure the clinical trial data is of high quality and integrity. The department consists of statisticians, data coordinator, data entry staff and if large, team leaders. Within Australia, many companies have their data management activities conducted overseas, however some companies do have large data management departments as well as few companies with a small Data Management Departments of only one or two members.
As a data coordinator, you can be involved in the design of the Case Record Form (CRF) and database, writing and testing validation programs, validating data, generating queries and data entry. When you first enter the data management department, the role will involve more data entry and validating work until you have gained sufficient experience to take on more complex responsibilities such as writing and testing validation programs. You will need to liaise with clinical and site staff in the resolution of queries.
Data Coordinators need to have a life science degree, experience in utilising databases, understand medical terminology and have good attention to detail and communication and negotiation skills. You can progress to team leader or management roles as well as develop your technical skills.
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Drug Safety / Pharmacovigalence
Drug Safety Associates (DSA) are involved in the tracking and coordination of Adverse Events (AE’s), a side effect that occurs during a clinical trial and Adverse Drug Reactions (ADR) a unexpected side effect that occurs once a product has been marketed. Within Australia, this role may be handled by the overseas Head Office or within a department, such as clinical or medical information. However there are quite a few companies who have a local Drug Safety/Pharmacovigalence Department.
A DSA is involved in writing the safety summary, collating the required information, liaison with internal departments and the site / hospital staff to gather any further required information. It is a role that requires rapid response and reporting to the applicable authorities.
DSAs need to have strong communication and written skills, be familiar with medical terminology and be highly organised. You will need to have a life science or nursing degree qualification.
Within Australia, Health Outcomes and Health Economics play a vital part in the planning and preparation of clinical and economic evaluations, registration of the product and product listing and pricing. The work involves collating information, such as for a Pharmaceutical Benefits Advisory Committee (PBAC) submission and providing economic evaluations into the clinical protocols, new indications etc.
Generally, you will need to have a degree in sciences or economics with experience in clinical research / regulatory, be analytical, have strong research experience and proven written skills. A postgraduate qualification in Health Economics, Epidemiology or Biostatistics is also usual required.
The Medical Information Department or Medical Affairs Department provides information on company products to external customers and internal departments, ensures compliance with the code of conduct and works closely with marketing departments.
The Medical Information Associate (MIA) role generally involves a large portion of answering queries and handling product complaints over the telephone. It involves retrieving information through measures such as the company database, conduct literature searches and journal reviews. As experience is gained, you will be able to take on more responsibilities and tasks, such as responsibility for a therapeutic area, training company staff, such as sales representatives on products and therapeutic areas, write or review product and promotional material and review for compliance with the MA code of conduct.
MIAs generally have a pharmacy or pharmacology qualification. Other requirements include, strong communication and interpersonal skills for dealing with customers, be able to prioritise, be organised and have good written skills.
The Regulatory Affairs Department is involved in preparing documentation for approval of new products, coordinating the approval process for the change in labeling and packaging on existing products and also preparing documentation and coordinating regulatory approval to changes to existing product licenses. Often regulatory affairs is involved in ensuring the regulatory requirements for clinical trials are adhered to. In Australia the TGA accepts both a Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) for the conduct of clinical trials. Although the CTN is the most common and popular route, the Regulatory Affairs Department is involved in determining the best strategy for that product.
A Regulatory Affairs Associate (RAA) coordinates regulatory matters between the company and the regulatory bodies, such as the Therapeutics Goods Administration (TGA), Australia’s regulatory body. As a RAA, you are predominantly involved in collating and writing information. You may be involved with regulatory authorities overseas such as New Zealand and Asia Pacific. Once you have gained experience, you may be able to take on additional responsibilities for a therapeutic area or product, be involved in strategies and perhaps meet with the regulatory authorities to discuss issues or strategies. Often the Head Office puts the total regulatory strategy together, however, it is likely the Australian office provides input into the Asia Pacific regulatory strategy.
RAAs require strong written and verbal communication skills. You need to have strong organisational skills, enjoy analysing and collating data, and have exceptional attention to detail. A life science background is essential and often honours or Ph.D. is favourable.
The study coordinator is part of the site research team, working with the investigator to ensure the management and the administration of the trial is conducted in accordance with the protocol, Good Clinical Practice (ICH GCP) and regulations. The study coordinator may work across a number of studies that are in different stages and work with a number of Clinical Research Associates (CRAs) from different companies.
As a study coordinator, you could be involved in ethics submissions, recruiting patients, coordinating patient visits, conducting protocol specific tests, completing study documentation, such as Case Record Forms (CRFs), meeting and liaising with the CRA and resolving queries.
Generally, you need to have a nursing qualification, although this is not always required. Preferably you will have a strong knowledge of the therapeutic area being studied and an understanding and training in ICH GCP. You will need to be highly organised, enjoy administrative tasks, have strong communication and negotiation skills and enjoy variety. This role is a good stepping-stone to a CRA role.
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Disclaimer
The information included in this document is included in good faith. We recommend that you use this information as a guide only and do not rely on it in any way. Jobs @ Pharma in Focus does not guarantee the accuracy of any information and will not be held responsible for any loss or inconvenience, however caused if this information is taken as fact.
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