- Oct 3, 2016
- 0
- Category........
- FSW
- NOC Code......
- 5122
- App. Filed.......
- 09-04-2017
- AOR Received.
- 09-04-2017
- IELTS Request
- Upfront
- Med's Request
- Upfront
- Passport Req..
- 21-07-2017
- VISA ISSUED...
- 25-07-2017
- LANDED..........
- 28-Mar-2018
We have received an ITA and my wife is the primary applicant. I have a query regarding the NOC Code for my wife's current job in Regulatory Affairs. The job description, qualifications, and experience are as follows:
Regulatory Affairs Competencies and Proficiency Level include:
1. Therapeutic area and product knowledge, understanding of drug development process
2. Demonstrated project or submission management capabilities
3. Familiarity with Industry trends and forums, FDA and/or EU, and ROW regulations and guidelines
4. Good working knowledge of Document Management Systems, i.e., Documentum, Microsoft Word, Adobe, PDF Manipulation Tools i.e. ISI Toolbox, and related submission publishing tools (i.e. ISI Publisher, Insight Publisher)
5. Experience with document formatting, word processing, use/applications of templates and ensuring submission readiness (i.e. bookmarking, hyperlinking and navigational aids)
Current Job Description:
1. Maintain full understanding of components and complex formats of Non Clinical, Clinical, CMC, Drug Safety reports and Compliance Checking process of Annexes, PDF Documents including Literature References.
2. Maintain familiarity with Client-specific publishing standard operating procedures and work instructions.
3. Capture publishing activity data for each published report in the Tracking Sheet.
4. Provide publishing and QC support to the project management team and manage publishing tasks.
5. Ensures that the quality and TAT targets defined are met at all times.
6. Electronically compile submission dossier structures and published output in eCTD or non‑eCTD format based on established dossier plan for assigned products, submission types, and regions or countries in collaboration with RSMO Submission Leads and key business stakeholders.
7. Ensure relevant submission-excellence processes are applied from submission publishing and production of regulatory submissions are complete, properly formatted, and comply with global, regional and/or country-specific regulatory requirements as appropriate.
8. Perform various submission support activities including submission QC and component-level publishing for files in Portable Digital Format (PDF) per submission-readiness requirements and in conformance with internal standards and practices, as needed.
9. Participate in independent or team-based projects focused primarily on process improvement initiatives or the testing and implementation of new submission-related technologies
Previous Experience:
Company A and B [NOC Code: 5122 - Editors]
1. Editing and double-checking manuscripts to ensure an error-free output to meet international standards of publication
2. Understanding various journal requirements and ensuring that articles adhered to the desired format and guidelines for successful publication
3. Working alongside esteemed and renowned editing professionals with relevant experience ranging form 5-20 years in order to assist researchers in their publication process
4. Resolving author queries regarding their articles and any aspect of the publication process
5. Providing additional assistance to the author, until stage of publication and beyond
6. Catering to all stakeholders in the publication industry - the author, the publisher, and the reader
Please advice the appropriate NOC code for the current job.
I have already tried contacting both noc@workingincanada.gc.ca and NC-NOC-CNP-GD@hsrsdc-rhdcc.gc.ca, but the e-mails went undelivered OR unanswered.
Please help!
Thank you!
Regulatory Affairs Competencies and Proficiency Level include:
1. Therapeutic area and product knowledge, understanding of drug development process
2. Demonstrated project or submission management capabilities
3. Familiarity with Industry trends and forums, FDA and/or EU, and ROW regulations and guidelines
4. Good working knowledge of Document Management Systems, i.e., Documentum, Microsoft Word, Adobe, PDF Manipulation Tools i.e. ISI Toolbox, and related submission publishing tools (i.e. ISI Publisher, Insight Publisher)
5. Experience with document formatting, word processing, use/applications of templates and ensuring submission readiness (i.e. bookmarking, hyperlinking and navigational aids)
Current Job Description:
1. Maintain full understanding of components and complex formats of Non Clinical, Clinical, CMC, Drug Safety reports and Compliance Checking process of Annexes, PDF Documents including Literature References.
2. Maintain familiarity with Client-specific publishing standard operating procedures and work instructions.
3. Capture publishing activity data for each published report in the Tracking Sheet.
4. Provide publishing and QC support to the project management team and manage publishing tasks.
5. Ensures that the quality and TAT targets defined are met at all times.
6. Electronically compile submission dossier structures and published output in eCTD or non‑eCTD format based on established dossier plan for assigned products, submission types, and regions or countries in collaboration with RSMO Submission Leads and key business stakeholders.
7. Ensure relevant submission-excellence processes are applied from submission publishing and production of regulatory submissions are complete, properly formatted, and comply with global, regional and/or country-specific regulatory requirements as appropriate.
8. Perform various submission support activities including submission QC and component-level publishing for files in Portable Digital Format (PDF) per submission-readiness requirements and in conformance with internal standards and practices, as needed.
9. Participate in independent or team-based projects focused primarily on process improvement initiatives or the testing and implementation of new submission-related technologies
Previous Experience:
Company A and B [NOC Code: 5122 - Editors]
1. Editing and double-checking manuscripts to ensure an error-free output to meet international standards of publication
2. Understanding various journal requirements and ensuring that articles adhered to the desired format and guidelines for successful publication
3. Working alongside esteemed and renowned editing professionals with relevant experience ranging form 5-20 years in order to assist researchers in their publication process
4. Resolving author queries regarding their articles and any aspect of the publication process
5. Providing additional assistance to the author, until stage of publication and beyond
6. Catering to all stakeholders in the publication industry - the author, the publisher, and the reader
Please advice the appropriate NOC code for the current job.
I have already tried contacting both noc@workingincanada.gc.ca and NC-NOC-CNP-GD@hsrsdc-rhdcc.gc.ca, but the e-mails went undelivered OR unanswered.
Please help!
Thank you!
