Ctry Approval Spec - Ministry of Health

SS041 - Country Approval Specialist

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: toimprove health.You will be joining a trulycollaborative and winning cultureas we strive to bend the time and cost curve of delivering life-saving therapies to patients.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.

Summarized Purpose:

As a MoH Country Approval Specialist, you are responsible for creating regulatory Submissions for new studies to Health Canada. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Essential Functions:

· Prepares, reviews and coordinates, under minimal guidance, local regulatory submissions (MoH, , additional special national local applications if applicable, e.g. pharmaceutical, biologic, and radiopharmaceutical dossiers,) in alignment with global submission strategy

· Provides, under guidance local regulatory strategy advice (MoH) to internal clients

· Provides project specific local SIA services and coordination of these projects

· Key-contact at country level for Regulatory submission-related activities

· Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for the study are aligned to the critical path for site activation

· Responsible for maintenance of regulatory intelligence database to better support communication of changes within the regulatory landscape

· Act as a Subject Matter Expert for the North America Country Team providing guidance related to Health Canada Regulations.

· Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner

· Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs

· Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

SS041 - Country Approval Specialist

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: toimprove health.You will be joining a trulycollaborative and winning cultureas we strive to bend the time and cost curve of delivering life-saving therapies to patients.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.

Summarized Purpose:

As a MoH Country Approval Specialist, you are responsible for creating regulatory Submissions for new studies to Health Canada. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Essential Functions:

· Prepares, reviews and coordinates, under minimal guidance, local regulatory submissions (MoH, , additional special national local applications if applicable, e.g. pharmaceutical, biologic, and radiopharmaceutical dossiers,) in alignment with global submission strategy

· Provides, under guidance local regulatory strategy advice (MoH) to internal clients

· Provides project specific local SIA services and coordination of these projects

· Key-contact at country level for Regulatory submission-related activities

· Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for the study are aligned to the critical path for site activation

· Responsible for maintenance of regulatory intelligence database to better support communication of changes within the regulatory landscape

· Act as a Subject Matter Expert for the North America Country Team providing guidance related to Health Canada Regulations.

· Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner

· Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs

· Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years)

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

Effective oral and written communication skills

Excellent interpersonal skills

Strong attention to detail and quality of documentation

Good negotiation skills

Good computer skills and the ability to learn appropriate software

Good English language and grammar skills

Basic medical/therapeutic area and medical terminology knowledge

Ability to work in a team environment or independently, under direction, as required

Basic organizational and planning skills

Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner

Able to work upright and stationary and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments

Able to perform successfully under pressure while prioritizing

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD - 

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years)

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

Effective oral and written communication skills

Excellent interpersonal skills

Strong attention to detail and quality of documentation

Good negotiation skills

Good computer skills and the ability to learn appropriate software

Good English language and grammar skills

Basic medical/therapeutic area and medical terminology knowledge

Ability to work in a team environment or independently, under direction, as required

Basic organizational and planning skills

Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner

Able to work upright and stationary and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments

Able to perform successfully under pressure while prioritizing

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD - 

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.