Regulatory Submissions Publishing & Systems Coordinator

GSK - Mississauga, ON (30+ days ago)

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Site Name: Canada - Ontario - Mississauga
Posted Date: Jun 24 2020

GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and health-care companies, is committed to improving the quality of life by enabling people to do more, feel better, and live longer. GSK’s Regulatory Affairs department is a world-class team of professionals who are dedicated to excellence in all aspects of regulatory affairs. We are actively looking for a motivated, bold, decisive, and innovative team player to join and add value to our dynamic team. If you are an energetic, career-minded professional with a passion for leadership, a focus on solutions, and a commitment to outstanding performance, we invite you to apply to our exciting and rewarding role. We welcome applicants with previous experience working in Regulatory Affairs who are looking to gain valuable experience working with one of Canada’s best employers.

Primary Responsibilities:
Submission Responsibilities

Provides publishing, word processing and document management activities for the preparation of all regulatory submissions in paper and electronic formats for Canadian GSK products
Manages multiple submissions to ensure Health Canada submission deadlines are met
Inputs cross-references and annotations including hyperlinks when appropriate
Ensures compliance with Health Canada requirements (submission structure, formatting compliance with guidelines and policies)
Builds relationships with local/global contacts to facilitate submission efforts
Trains new staff/agency workers

Systems/Other Responsibilities

Lead user of many RA systems, identifying business/user requirements, testing and participating in the completion of appropriate computer systems documentation
Performs assigned tasks associated with document and regulatory fee management
Responsible for maintenance activities on behalf of RA such as custodian or administrator function, providing access control for RA systems, maintaining departmental connectGSK page, creating or updating RA submission templates
Participates and provides input on local RSPS teams, e.g. continuous improvement
Reviews projects to ensure compliance with applicable Health Canada, industry & GSK codes and guidelines in alignment with business needs

Qualifications Required:
University/College diploma or equivalent experience, preferably with a strong emphasis in information technology
Strong computer expertise including extensive word processing experience; ability to quickly adapt to new technology
Agile with the ability to react quickly, provide creative solutions to problems, and navigate change
Process improvement mindset
Excellent oral and written communications skills with the ability to present to small and large group
Accountable to simultaneously work on multiple projects and to meet tight timelines
Excellent attention to detail and accuracy of work
Act with integrity and demonstrate a strong quality mindset
Ability to provide and receive feedback, raise issues, share experiences and lessons learned
Proactive and seeks to constantly learn and develop. Ensures that skills meet changing business needs
Collaborative with the ability to work with diverse group of individuals in a team and to express opinions, including as part of group discussions. Open to diverse ideas, styles and perspectives

Preferred Qualifications:
Familiarity with specialized publishing software applications and document management systems
Specific knowledge about regulatory affairs and the drug development process
Knowledge and experience with CTD submission format
Experience with eCTD publishing tools and basic understanding of HTML, XML mark-up
Experience with Veeva Vault

  • LI-GSK
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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