ECTD publishing jobs in Canada are not as many as in USA although there are many qualified personnel around. Most of these jobs are found in Ontario and Quebec.  Activities related to eCTD publishing in Canada are  usually taken up by regulatory affairs personnel than designated eCTD publishers.

Education and Training for eCTD Publishing

Generally a Bachelor’s Degree in life sciences is required . In certain situations a bachelors degree in Chemistry might be required or acceptable. Usually a Regulatory Affairs certificate or a diploma from a private Career College or a community college is also required. If you are looking for an entry position do not ignore relevant training.  Any specialized training in eCTD format is acceptable if it provides you with the necessary skills required.

Experience in eCTD Publishing

Most jobs require at least 3 years of experience but this may be overlooked for good candidates with other skills described below. If you have experience in  paper publishing process you may be considered.  Typically you will be expected to know the process of publishing a new drugs submission, abbreviated new drug submission, responding to health Canada notices and other related activities. Although you will rarely compile a full submission alone except for generic products you are expected to understand the full process of a drug submission. Usually you will be given other responsibilities other than eCTD publishing.

Skills/Competencies

As many documents are prepared and submitted to regulatory agencies, you will be required to have knowledge of and experience in  formatting  documents. You will be required to have advanced skills in word processing  and publishing.

While you may not be expected to create xml files, experience with XML editors and publishing software such as Docubridge or similar software are required. You will need to know about eCTD publisher, viewer and Validator.

The job requires a strong understanding of the CTD structure. You must also have a strong understanding of  Health Canada,  FDA and ICH specifications relating to  eCTD submissions. These specifications are applied in the eCTD software.

In addition you must have a good knowledge of the pharmaceutical industry together with relevant regulations and guidance documents.

You must provide evidence during the interview or in your resume that you are committed to remain up to date in Canadian, USA and EU regulations if the company of interest is interested in those markets.

ECTD Publishing jobs require technical and soft skills

Typically you must have advanced skills in MS Word. You will often use it to create documents. Many people take this for granted and miss opportunities.

Ability to use professional  Adobe Acrobat or similar software  is a must for eCTD publishing . Some of the most important publishing skills include documents merging and splitting, creating bookmarks and hyperlinks among others.

While education and experience  are important, you may not pass the eCTD publishing  interview if you  don’t demonstrate that you have the skills described below. You must demonstrate that you have the ability to work independently without requiring much supervision. Sometimes you may have to work under pressure. This skill cannot be acquired in school but evidence can be provided from school related activities.

You must be able to prioritize tasks to meet   deadline. This is a transferable skill and it could be acquired in other jobs including customer support, office administration, teaching among others. You may be asked to proof with examples that you have this skill. Lack of this skill can result lose of the employment opportunity or  in financial lose by an employer.

You must also have  good organizational and problem-solving skills. If you are disorganized and can’t solve simple regulatory problems you will be disqualified during  the interview. You need this skill when problems come up the last minute before deadline. You may have to stay late to solve the problem.

You must also have follow-up skills. Quite often eCTD publishers will  rely on others for documents or information in the company. Without the ability to follow up you will not meet deadlines

You must also be able to pay attention to detail and generate  accurate and and reliable dossiers.

As you can eCTD publishing is not for anyone .

If you are you would like training in eCTD we have an online course. Contact us.

A related article will be published on this blog next week. Check it out.