Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions.
Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic), as applicable.
Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
Maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
Assemble electronic and paper Regulatory Submissions and packages for Health Canada, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using specialty EDMS/publishing software.
Perform quality review of Regulatory Operations team members work to ensure accuracy.
Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client.
Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required.
Maintain current knowledge of applicable regulations and industry best practices. Participate in the interpretation of guidelines and impact assessment to current work procedures. Anticipate Regulatory consequences and advise project teams on publishing issues and strategies.
Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and government agencies in a polite and professional manner.
Assist in the design and implementation of new processes or initiatives within the department.
Participate in special projects and carry out assigned activities in support of the Publishing function.
Knowledge/Skills/Attributes
· Community College Diploma or University Degree in Health Sciences or Information Technology / Computer Sciences or equivalent relevant experience and training.
· Intermediate to advanced working knowledge of MS WORD, Excel, and Adobe Acrobat.
· Time and resource management skills combined with a strong ability to multi-task.
· Ability to maintain a high level of accuracy and attention to detail.
· Excellent communication and interpersonal skills.
· Knowledge of a variety of computer programs including MS Office, Adobe Acrobat
· Ability to work collaboratively as part of a team.
· Time and resource management skills combined with a strong ability to multi-task.
· Ability to maintain a high level of accuracy and attention to detail.
· Awareness/knowledge of Health Authority regulations, guidelines, policies pertaining to electronic regulatory standards desirable
· Awareness/knowledge of eCTD standard desirable
· Excellent communication and interpersonal skills.
- Ability to work collaboratively as part of a team