Manager, Clinical Compliance & Licensing
Apply NowCompany: Alcon
Location: Boucherville, QC J4B 0A1
Description:
Job Description Summary
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our 'new' Sandoz!
Job Description
The role of the Manager, Clinical Compliance & Licensing is to provide leadership with respect to Canadian specific clinical requirements, interpretation and application of Health Canada Regulatory Guidance and Policy as well overall clinical strategies for Canadian filings.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
What you'll bring to the role:
Essential Requirements:
Desirable Requirements / Assets:
You'll receive:
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art 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.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool
#Sandoz
Skills Desired
Budget, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Financial Analysis, Health Sciences, Lifesciences
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our 'new' Sandoz!
Job Description
The role of the Manager, Clinical Compliance & Licensing is to provide leadership with respect to Canadian specific clinical requirements, interpretation and application of Health Canada Regulatory Guidance and Policy as well overall clinical strategies for Canadian filings.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Responsible for the preparation and/or review of Scientific Advice submitted to Health Canada.
- In charge of organizing pre-submission meetings with Health Canada.
- In collaboration with both internal & external stake holders, provide clinical guidance for licensing.
- Manage, review and participate in the establishment of annual audit plans with Global Clinical Assurance.
- Manage auditors and outsourcing/contracting/cooperation with external specialists in the conduct of clinical & non-clinical studies.
- Ensure regulatory compliance and monitor key quality and performance metrics for patient support programs and research collaborations. Implement and maintain a hands-on quality management system and manage the execution of all components (SOPs, Quality Control, Auditing).
What you'll bring to the role:
Essential Requirements:
- Minimum of master's in Pharmacology, Biochemistry, Chemistry, or a Pharmacy diploma.
- Minimum of 5 years of experience in Clinical regulatory and/or Scientific Affairs in Canada.
- Minimum of 1 year of Business Development & Licensing management.
- Minimum of 3 years in managing projects.
- At least 2 years of experience as a people manager.
- 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.
- Good knowledge with MS Office tools.
Desirable Requirements / Assets:
- Experience with SAP.
- Experience as a pharmacist, good asset.
- Experience in communicating with Health Canada.
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.
- Group pension plan with substantial employer contributions.
- Generous and flexible group insurance coverage through our private plan.
- Employee and family assistance.
- Hybrid work formula offered.
- Telemedicine services.
- Parental leave - supplemental top-up payments up to 100% of base salary, regardless of gender or sexual orientation.
- Career enhancement and development, including learning, training and professional recognition opportunities.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art 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.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool
#Sandoz
Skills Desired
Budget, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Financial Analysis, Health Sciences, Lifesciences