Job Specification

Purpose :

- To provide professional expertise and support regarding clinical, economic and utilization issues relating to drugs considered for reimbursement through Ontario's Drug Benefits program.

Key Responsibilities :

1. Expertise and Advice
- Provides professional and scientific knowledge and advice in the review of drug submissions to ensure that the clinical and pharmacoeconomic information is credible and sufficient.
- Consults with senior branch staff on contentious, precedent setting issues.
- Ensures technical accuracy of committee notes, briefing material, correspondence and other documentation.
- Provides analytical advice and interpretation to various stakeholders (e.g., consumer/professional organizations, staff)
on policies and issues related to Ontario's Drug benefits program
- Develops and maintains knowledge base of scientific and technical information to support branch/program activities
and CED.
2. Drug Submission Reviews and Projects
- Screens /reviews drug submissions and resolves complex submission issues.
- Researches, compiles, and analyzes clinical, pharmacoeconomic and utilization data.
- Prepares issues summary reports and analyses for review by the Committee to Evaluate Drugs (CED).
3. Policy/Program Development
- Develops and recommends policies and procedures that support the drug review process. Evaluates current policies and processes to develop recommendations.
- Improves the submission process by continuously identifying areas where efficiencies could be introduced or areas where interpretative guidelines require further clarification.
- Provides advice and support on drug related issues to other areas within the Branch, and other area of the Ministry
4. Stakeholder Relationship and Communications
- Communicates and liaises with stakeholders and manufacturers regarding submission/review status and
requirements.
- Acts as liaison with branch management and CED consultants to clarify issues and recommend viable solutions.
- Identifies and provides additional information to assist the ministry and the CED in decision-making.
- Maintains ongoing liaison with colleagues in other jurisdictions and stakeholder groups (e.g., pharmacists, physicians, drug manufacturers and ODB recipients).

Knowledge / Skill :

Bachelor's Degree in Pharmaceutical Sciences (B.Sc. Pharm., BSP or equivalent) and licensed by the Ontario College of Pharmacists.
Knowledge of and skills in:
- Pharmacology, therapeutics, epidemiology, health economics, trends in medical practice and technology used in prescribing and developing new drugs to provide pharmacology and scientific expertise/analysis/advice to ministry and CED to ensure a thorough and fair drug review process.
- Federal/provincial legislation and ministry policy relating to drugs and pharmacy and medical practice to ensure drug submissions are reviewed in a fair and consistent manner and comply with requirements.
- Stakeholder issues in relation to overall purpose of ODB program to develop and analyze viable
proposals/policies/solutions, develop recommendations for new/revised policies.
- Hospital and retail pharmacy practice, medical practice, health care delivery, pharmaceutical industry and current issues relating to use and reimbursement of drug products to ensure that accurate relevant information/analyses are provided to the advisory committee and the ministry.
- Project management to coordinate studies, data collection and analyses.
- Program analysis, policy development and related Ministry decision-making and approvals processes in order to analyse and assess a broad range of issues, trends, legislation and service delivery methodologies and develop impact analyses and policy/program options.
- Written and oral communication to take meeting minutes, prepare briefing notes, technical reports, recommendations, correspondence and other materials.
- Computer applications for communication products, word processing, spreadsheets, internet searches, database analysis, and tracking/reporting systems.

Interpersonal / Influencing Skill :

- Persuasion and negotiation skills to discuss/attempt to resolve complex drug submissions issues/requirements, policies/procedures with ministry management and colleagues; clarify issues; provide analyses and recommendations.
- Advisory skills to guide pharmaceutical industry on drug submission data requirements, deficiencies, regulations, policies, issues.
- Facilitation and presentation skills to conduct meetings, participate in a variety of work groups and committees, share information on drug products and regulations/policies with colleagues and officials, deal with different perspectives and divergent views.

Analyzing / Problem Solving Skill :

Analyzing and problem solving skills to:
- Compile and analyze cost comparison, utilization of drug products, impact analyses for the branch/ministry and the CED in order to support decision making.
- Identify and research clinical, economic and process related issues.
- Research a range of data, drug utilization issues, and trends.
- Evaluate current data and issues to formulate solutions; recommend policies/ procedures/guidelines
- Identify potentially contentious issues for referral to senior management.

Decision Making / Responsibility :

Responsible for:
- Screening drug submissions in compliance with legislation and regulations.
- Providing professional, critical evaluations of clinical and pharmacoeconomic data in drug submissions and ensuring consistent, fair, timely assessment.
- Developing and compiling complete and accurate clinical and pharmacoeconomic data and analyses of drug products to support CED decision-making.
- Developing and implementing policies and procedures which improve/facilitate the review process.
Has latitude to recommend resolutions to clinical, pharmacoeconomic and process related issues; decide whether or not data submitted by manufacturers is sufficient.
Decisions/recommendations are guided by the framework of legislation, ministry policies and guidelines governing drug programs, federal/provincial drug and pharmaceutical related legislation, regulations, guidelines, protocols and professional standards.

Contacts / Stakeholder :

- Branch colleagues, management and staff to discuss drugs submissions issues, policies and procedures; develop and
analyze viable proposals/policies/solutions.
- External stakeholders (e.g., pharmacists, physicians, drug manufacturers, patients) to interpret policy/programs;
communicate drug review status/decisions; develop and analyze viable proposals/policies/solutions.
- External advisory committee, expert consultants to facilitate drug reviews.
- Counterparts in other jurisdictions and levels of government to participate in discussions relating to pharmacy related
guidelines, standards, trends and issues.
- Staff from other ministries to discuss policies, legislation and issues relating to available benefits.

Guidance / Supervision :

- Provides technical and process guidance to CED Coordinators, members, consultants on submissions and related issues.
- Provides technical guidance to branch colleagues in understanding CED recommendations.
- Provides technical advice/guidance to staff Drug Submissions Coordinators on drug submission screening.

Demands / Pressures :

Work Demands :

- Frequently required to respond to information requests unexpectedly and with short deadline.
- Routinely required to coordinate multiple projects/issues simultaneously.

Mental / Sensory :

Frequent listening intently to take meeting minutes. Frequent periods of concentration to review drug submissions and to read scientific and technical materials.

Conditions / Environment :

Work is performed in a typical office environment.