Clinical Compliance and Licensing Specialist

2 weeks ago


Montréal, Canada Sandoz Full time

Job ID- 381482BR- Aug 22, 2023- Canada**Job Description**:

- #1 is the position Sandoz Canada will achieve in the Bio-Generic market by 2025. The Specialist, Clinical Compliance and Licensing will be responsible for providing leadership with respect to Canadian clinical requirements and ensure that submissions are compliant with GCP, Sandoz and Health Canada requirements.- Oversees clinical study activities with Sandoz Development Centers, third parties and CROs to ensure that GCPs and Sandoz requirements are followed.
- Ensure that essential documentation is received according to set timelines to support clinical trial activities.
- Provide feedback on clinical study protocols and study designs. Represents sponsor for on-site monitoring at clinical trial sites when applicable. Ensures that the monitoring reports are accurate and that study report is suitable for submission to Health Canada.
- Prepare recommendations on clinical strategies for all projects involving clinical component.
- Support clinical due diligence activities for local and global business development evaluations.
- Prepare Scientific Advice packages submitted to Health Canada.
- Responsible for the evaluation of Access to Information requests and oversees activities related to the Public Release of Clinical Information.

**Diversity & Inclusion / EEO**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Minimum Requirements**:

- Bachelor in pharmacy, pharmacology, biochemistry, etc.
- 5 to 8 years of experience as clinical project manager/clinical research associate.
- In-depth knowledge of current clinical Canadian guidelines and good knowledge of EU and US clinical requirements.
- Strong knowledge and understanding of GCP related requirements, clinical design and strategy.
- Very good analytical thinking skills.
- Ability to manage multiple projects and priorities.
- Sense of organization and autonomy.
- Excellent oral and written communication skills in English and French.

Division

SANDOZ

Business Unit

COMMERCIAL OPS NA SZ

Location

Canada

Site

Montreal South Shore - Boucherville

Company / Legal Entity

Sandoz Canada

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Temporary

Shift Work

No



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