Job Description

Do you have strong analytical, relationship management, and communication skills, with demonstrated knowledge of regulations and legislation to support the drug submission process?

Join the ministry of Health, Drug Submission Group where you will provide expert professional advice on the analysis of drug submissions; manage policy and procedural development and implementation for the Drug Submissions Group.

OPS Commitment to Diversity, Inclusion, Accessibility, and Anti-Racism:

We are committed to build a workforce that reflects the communities we serve and to promote a diverse, anti-racist, inclusive, accessible, merit-based, respectful and equitable workplace.

We invite all interested individuals to apply and encourage applications from people with disabilities, Indigenous, Black, and racialized individuals, as well as people from a diversity of ethnic and cultural origins, sexual orientations, gender identities and expressions.

Visit the OPS Anti-Racism Policy and the OPS Diversity and Inclusion Blueprint pages to learn more about the OPS commitment to advance racial equity, accessibility, diversity, and inclusion in the public service.

We offer employment accommodation across the recruitment process and all aspects of employment consistent with the requirements of Ontario's Human Rights Code. Refer to the "How to apply" section if you require a disability-related accommodation.

What can I expect to do in this role?

In this role, you will:

• Manage the development of appropriate tracking systems, reports, instruction manuals and staff training.
• Manage the review, analysis, and processing of submissions from drug manufacturers which are of an extremely technical and detailed scientific nature.
• Ensure the consistent application of regulatory requirements and interpretation of drug submission data in a highly sensitive area.
• Provide expert pharmaceutical analysis, advice, and recommendations to Branch management, the Committee to Evaluate Drugs (CED) and Ministry staff concerning the resolution of complex and precedent-setting submission issues.
• Play a leadership role in strategic initiatives such as the Common Drug Review process generic streamlining, and other Federal-provincial tasks as assigned.
• Manage the development, review, implementation and maintenance of relevant policy, procedures and regulations related to the Branch's drug submissions program.
• Manages effective communications concerning drug submission regulations, interpretative guidelines, policies and the review process in order to promote a more efficient process and foster good relationships.
• Contribute to the research and development of issues management and briefing notes on regulations, policies and other drug submission issues for Branch and Ministry senior management.
• Acts as a member of the Drug Benefits Management team and lead/participate in Branch/Ministry committees.

How do I qualify?

Mandatory

This position requires a degree in Pharmacy and eligibility for license in Ontario.

Technical Knowledge and Analytical Skills

• Knowledge of pharmacology and pharmacotherapy, as well as an understanding of pharmacoeconomics and critical appraisal in order to provide expert analysis and advice.
• Knowledge of the regulations and legislation governing the federal and provincial drug submission review process.
• Knowledge of the pharmaceutical manufacturing industry, drugs/health sciences and analytical methods to interpret complex data in order to identify submission issues, discuss them authoritatively with specialists, and provide viable analysis and recommendations to the Committee to Evaluate Drugs (CED).
• Knowledge of database applications, spreadsheet and word processing software to maintain records, prepare reports, and manage the development of effective tracking and reporting systems.
• You can implement quality assurance processes and performance measures to evaluate program effectiveness and maintain program standards.
• The ability to assess the impact on Drug Submission policies and procedures of changes in legislation or government policies,

Leadership, and Relationship Management Skills

• The ability to manage program delivery in a high-pressure environment with tight performance targets, manage section staff and budget, and provide direction on contentious issues.
• You can resolve complex submission issues with manufacturers, other agencies, Branch staff and the Committee to Evaluate Drugs (CED) members.
• Written communication skills to prepare briefing notes, guidelines, policies, correspondence, and reports.
• The ability to provide clear and effective communications with drug manufacturers and other stakeholders to improve the efficiency of the process and the quality of submissions and promote good stakeholder relations.

Problem Solving and Project Management Skills

• The ability to provide professional analysis and recommendations which have a significant impact on the timing and disposition of drug reviews.
• The ability to identify and resolve complex and unique issues in individual manufacturer's drug submissions and in interpreting the application of regulations requirements and guidelines.
• You have project management skills to take a lead role in branch strategic initiatives and participate in provincial and federal committees.
• You have decision-making skills to analyze issues and formulate solutions in a highly technical and sensitive area, and to develop and implement effective policies, guidelines and procedures.
• You can develop and manage operational plans, policies, processes, and systems for efficient and accountable program delivery.

Additional Information:

Address:

• 1 Permanent, 5700 Yonge St, North York, Toronto Region

Compensation Group:
Association of Management, Administrative and Professional Crown Employees of Ontario


Understanding the job ad - definitions Schedule:
6


Category:
Health and Social Services


Posted on:
Monday, August 15, 2022

Note:

• T-HL-185622/22