Manager, Systems and Information Management

Important messages

Health Canada has an exciting management opportunity for a proven leader from the Regulatory, Pharmaceutical or other science-based industries! We are seeking to fill a leadership role that will help our team manage the electronic regulatory processes and system for intake and review of drug and medical device applications. The system and processes allow for the efficient management of regulatory applications seeking authorization to market in Canada. The successful applicant will lead a team engaged in a number of exciting initiatives, such as:

• The development of IT options and business change management solutions for the delivery of a branch-wide electronic submission processing environment;
• Developing solutions for the implementation of two-way communications using our systems to improved intake processes and increase integration with the other systems;
• Overseeing the development and maintenance of guidance documents, including the electronic Common Technical Document (eCTD) and non-eCTD guidance, which outline the formatting requirements for Health Product and Food Branch submissions;
• Overseeing the ongoing maintenance of the submission viewing and IM tool (docuBridge) and workflow tools, including administrative support, developing standard operating processes, training for new and existing staff, account creation, testing and yearly upgrades to the system;
• Representing us before stakeholders, such as industry assoications, to promote and obtain buy-in on continuing to increasing the efficiency of the electronic submission intake processes.

If you are a proven leader from a science-based area, apply today to see what Health Canada can offer you!

Duties

Health Canada is the federal department responsible for helping Canadians maintain and improve their health. Our goal is for Canada to be among the countries with the healthiest people in the world. Within Health Canada is the Health Products and Food Branch (HPFB). HPFB’s mandate is to manage the health-related risks and benefits of health products and food by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food and providing information to Canadians so they can make healthy, informed decisions about their health. We work to protect and promote the health and safety of Canadians by being a trusted scientific and regulatory authority for health products and food in Canada and internationally.

This position is located within HPFB’s Resource Management and Operations Directorate (RMOD). We provide oversight and coordination of the Health Products and Food Branch's corporate policies and activities, issue Drug Identification Numbers, and administer drug-related intellectual property regimes. As a manager on our RMOD team, you will take on a key leadership role within our Office of Submissions and Intellectual Property. You will be responsible for managing a diverse team who are tasked with the maintenance of the IT systems used for the intake, viewing and workflow of drugs and medical device submissions, adopting the formatting standards for drugs submissions and developing new processes and systems to increasingly automate the submission intake processes. As well, this position manages the day-to-day operational support.

What we are looking for:

We are seeking to provide growth opportunities for a proven leader from a science-based industry. You will have experience leading in a science-based environment, an understanding of the eCDT or a related electronic regulatory system, keen project management skills, and a desire to take your career to the next level by leading this diverse team! You are able to build and maintain effective interpersonal relationships, both internally and externally. Successful candidates will need to possess excellent judgement be creative in finding new ways to work and not be afraid to challenge themselves. This position also requires advanced bilingualism (Bilingual – Imperative CBC/CBC) in Canada’s Official Languages (English and French).

Please see below for further information on this aspect as well as self-assessments.

Work environment

Why work for Health Canada?

FIND WORK-LIFE BALANCE
Health Canada takes the wellness of our employees seriously. From flexible hours to compressed schedules, you will find the time you need for the things that you love.

JOIN A SUPPORTIVE AND INCLUSIVE WORK ENVIRONMENT
From our Employee Assistance Program, which provides mental health support for you and your family members, to a senior management cadre that supports your growth and development, you will never lack opportunity. From an inclusion perspective, we want you to bring your whole self to work! We encourage all qualified candidates to apply, regardless of race, colour, religion, sex (including gender identity and/or expression), national origin, sexual orientation, civil union or relationship status, disability, age, parental status, military service, or other status protected under federal law.

Everyone is welcome! Health Canada is are dedicated to building an inclusive workforce that comprises individuals who have an array of identities, abilities, background, culture, skills, perspectives, and experiences that are representative of Canada’s current and evolving population. We are passionate about fostering a workplace where all people feel welcome, can reach their full potential, and contribute their unique perspectives and experience to the success of the team.

PENSION AND HEALTH BENEFITS FOR YOU AND YOUR FAMILY
We offer a top-notch Health and Dental benefits plan for you and your family that is 100% employer-paid at the base level. Moreover, you can rest assured that your retirement will be protected with our excellent Pension plan.

WORK IN A WORLD CLASS CITY
Your team is located in Ottawa, Ontario. While we presently working from home, the IT requirements for this position may require your physical presence in the office. Should relocation to Ottawa be necessary, you will be provided with up to $5000 to help you settle into your new home in this world-class city. Flexible work arrangements, such as alternative schedules and occasional remote work, may also be available.

AND, SO MUCH MORE! APPLY TODAY AND SEE WHAT WE HAVE TO OFFER.

Intent of the process

The intent of this process is to hire for one (1) indeterminate (permanent) positions. Applicants should note that this process will also be used to create a fully or partially qualified pool (list of candidates) that may also be used to staff similar positions within the Federal Public Service.

Current employees of the federal public service may be considered for deployments, assignments, secondments, actings or interchange.

Positions to be filled: 1

Information you must provide

Your résumé.

A covering letter "(no more that 5000 words) that clearly outlines how you meet the required education and experience (essential qualifications) needed for the position. If you have any of the asset education or experience, which are nice to have but not required, please ensure this is clear on your cover letter as well."

In order to be considered, your application must clearly explain how you meet the following (essential qualifications)

Education:

Graduation with a degree from a recognized university with acceptable specialization in microbiology, chemistry, pharmacy, or some other specialty related to the position.

Degree equivalency

Experience:

Experience in providing leadership in a science-based environment.
Experience in project management such as management of Information Technology or Regulatory projects.
Experience in administering, coordinating or implementing electronic regulatory activities.
Experience establishing and maintaining working relationships with stakeholders such as clients, industry, or academia.
Experience in providing strategic advice, briefings and recommendations to decision makers (Director level and above in the Public Service, Manager or above in the private sector).

The following will be applied / assessed at a later date (essential for the job)

Bilingual - Imperative (CBC/CBC)
Second Language Writing Skills Self-Assessment

In order to help you decide if you should apply to a bilingual position, a self-assessment tool in your second official language is available for you to take before completing your application. Please visit the following link: https://www.canada.ca/en/public-service-commission/services/second-language-testing-public-service/self-assessment-tests.html

In the Public Service, a Bilingual Imperative CBC/CBC position is considered to require an advanced level of bilingualism. Therefore, candidates who are successful in obtaining an advanced level in the "Unsupervised Internet Test of Second Language Writing Skills" will be invited to proceed first in this process.

For more information, please consult:
Unsupervised Internet Test of Second Language Writing Skills

Information on language requirements

Knowledge:

Knowledge of the electronic Common Technical Document (eCTD).

Abilities:

Ability to communicate effectively orally.
Ability to communicate effectively in writing.
Ability to provide regulatory advice.
Ability to make presentations.

Personal Suitability:

Respectful of diversity
Leadership
Judgement
Effective Interpersonal Relations

The following may be applied / assessed at a later date (may be needed for the job)

Asset Education:

Graduation from a recognized post-secondary institution with a post-graduate certificate in Regulatory Affairs or Pharmaceutical Quality Assurance, or another specialty related to the position.

Degree equivalency

Asset Experience:

Five (5) or more years of experience in providing leadership in a science-based environment.
Experience in developing, writing or reviewing new or existing standards, policies or guidelines related to regulatory activities.

Willingness and ability to work overtime.
Willingness and ability to travel upon request.

Conditions of employment

Secret security clearance - we will help you obtain this as part of the hiring process

Other information

The Public Service of Canada is committed to building a skilled and diverse workforce that reflects the Canadians we serve. We promote employment equity and encourage you to indicate if you belong to one of the designated groups when you apply.

Information on employment equity

We are committed to providing an inclusive and barrier-free work environment, starting with the hiring process. If you need to be accommodated during any phase of the evaluation process, please use the contact information below to request special accommodation. All information received in relation to accommodation will be kept confidential.

Information on accommodation for persons with disabilities
https://www.canada.ca/en/public-service-commission/jobs/services/gcjobs/information-candidates/accommodations.html

You are entitled to participate in the appointment process in the official language of your choice (English or French). You are asked to indicate your preferred official language in your application.

Please note that our intent is to begin by assessing applicant's abilities in their second official language before proceeding with other formal assessments. We may use the Unsupervised Internet Test to determine the order of assessment for this process.

Reference checks may be sought.

An interview may be administered.

A test may be administered.

An assignment, secondment, or acting appointment requires approval of your supervisor.

You must provide proof of your education credentials.

A random and/or top down selection of candidates may be used in the determination of those to be given further consideration in the assessment process.

We thank all those who apply.

Preference

Preference will be given to veterans first and then to Canadian citizens and permanent residents, with the exception of a job located in Nunavut, where Nunavut Inuit will be appointed first.

Information on the preference to veterans

We thank all those who apply. Only those selected for further consideration will be contacted.