Reference No. R2741565
Position Title: Medical Operations & Transformation Lead
Department: General Medicines Medical Canada
Location: Hybrid Role based in Toronto, Ontario
About Sanofi - www.sanofi.ca
At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
As one of Canada's leading investors in life sciences, manufacturing and research and development, we focus on delivering new and better ways to address unmet medical needs. Our life-changing and lifesaving products are grounded in science that Canadians can trust. They empower self-care, prevent and treat diseases, and help people live better.
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Sanofi Canada operations focus on four therapeutic areas: General Medicines(diabetes, cardiovascular, arthritis, transplant, and thyroid cancer); Specialty Care(rare diseases, rare blood disorders, oncology, immunology, multiple sclerosis); Vaccines(manufactures, formulates, fills, inspects and/or packages vaccines and biologics, protecting against 20 infectious diseases including pertussis, diphtheria, tetanus and influenza); and Consumer Healthcare(pain care, allergy, digestive health, personal care).
Position Summary:
Under the oversight of the Medical Head, PCBU, the Medical Operations Officer provides leadership support and operational execution support to the PCBU medical affairs department to establish, implement and execute on project budget planning and reviews to ensure appropriate prioritization of Medical projects across the portfolio.
Specific responsibilities include, but are not limited to operational aspect:
- Be the main point of contact with the Medical Quality Officer to ensure adherence and consistency in quality approach (Ethics, Transparency and Compliance) in medical & clinical activities within the PCBU.
- Enhance performance & ensure continuous process improvement and simplification for the benefit of business objectives related to medical activities.
- Support the country medical team in the operational management of activities under Medical.
- Manage and track the affiliate PCBU Medical budget.
- Represent PCBU Medical in matters of operational excellence with other functions in the company (Medical Quality Officer (MQO), Country Quality Head, Country Compliance Head, Country Safety Lead, Medical Information, MRPQ, CSU,).
- Manage projects/initiatives within affiliate where Medical PCBU are involved.
Key Responsibilities:
- Ensure strategic alignment with MQO for PCBU Medical Department and share key relevant information within medical department as appropriate.
- Coordinate preparation and follow-up of PCBU Medical Department budget.
- Support the appraisal of the medical PCBU activities linked to medical KPis (Data Generation, Data Dissemination, Budget, MSL, ISS) propose action plan and monitor implementation and prepare a monthly KPI report/ dashboard.
- Monitor the overall quality of local clinical projects and performance (CSS/ ISS). Perform an ultimate quality check of Study Outlines (SO) and Clinical Study Reports (CSR) and monitor the Local/Regional/Global Medical Review (local SRC, SRC, CSR Review, etc.). Track the affiliate publication activity (Matrix system, journal submission) Overall monitoring of CTMS quality (Vision Tracker)and compliance.
- Act as focal point for local deployment of global tools (4M Zinc, NAYA Cross-Border Platform, Basic Call Tracking ... ) for medical PCBU.
- Work with the relevant functions to identify local training needs and define training strategy for medical PCBU, and ensure on boarding and continuous medical training is in place and secure training.
Maintain Compliance
- Abide by the requirements of the internal Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company.
Ethical Leadership
- Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
Key Working Relationships:
INTERNAL
Cross Functional Collaboration with:
- Affiliate Quality Commercial Operations, Country Quality Head, Quality GxP Audit, Country Compliance Head, Country Safety Lead, Global Medical Information, Country MRPQ, CSU, CQPTA.
- Medical Affairs Clinical Operations.
EXTERNAL
Would be expected to be involved with:
- Service Providers (Vendors, CROs, etc.)
- HCPs for projects
Key Requirements:
- Scientific background (University degree: bachelors (science domain)
- At least 2-years' experience in the Pharmaceutical industry (clinical, medical and/or quality departments)
- Experience in working in an cross-functional organization
- Good knowledge of company policies and procedures
- Knowledge of Medical Affairs/Regulatory Affairs/Pharmacovigilance/Clinical Operations.
- Fluency in English/French
- Leadership and robust project management skills
- Ability to work in multi-disciplinary environment
- Performance and Quality orientation
- Effective listening and communication skills
- Autonomy and personal organization skills
- Innovation and creativity
- Act for Change
- Cooperate Transversally
- Develop People Self / Other
Pursue Progress
Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
Watch ourALL IN videoand check out our Diversity, Equity and Inclusion actions atsanofi.com!
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
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