Specialist, Clinical Compliance

5 days ago

Boucherville, Canada Sandoz Full time

**Your Key Responsibilities**:
Your responsibilities include, but not limited to:

- 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 components.
- 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.

**What you’ll bring to the role**:
**Essential 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.
- Fluency in oral and written French is mandatory. Due to the nature of our operations, oral and written fluency in English is required for regular communication with customers, partners, and/or colleagues, whether in Canada or internationally.
- Very good analytical thinking skills.
- Ability to manage multiple projects and priorities.
- Sense of organization and autonomy.

**You’ll receive**:

- A minimum of three weeks’ vacation.
- Paid time off in addition to your annual vacation and statutory holidays.
- Time back between Christmas and New Year’s Day with full pay.
- Generous and flexible group insurance coverage through our private plan.
- Employee and family assistance.
- Hybrid work formula offered.
- Telemedicine services.
- Career enhancement and development, including learning, training and professional recognition opportunities.
- Sandoz Canada is proudly certified as a Great Place to Work _
- Learn more about the certification _. _

**Why Sandoz?**

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Join us

**Commitment to Culture & Inclusion**:Culture and inclusion | Sandoz**

**#Sandoz

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