Project Manager- Medical Governance

Job title: Project Manager – Medical Governance

• Hiring Manager: Supplier Operations Lead, Sanofi Business Operations
• Location: Hyderabad  
• % of travel expected: Travel required as per business need
• Job type: Permanent and Full time

About the job

Our Team:

Sanofi Hub is an internal Sanofi resource organization based in India or Eastern Europe ( Need to add location)  and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. Sanofi Hyderabad Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ in Sanofi, globally.

Main responsibilities:

Project Manager – Medical Governance will be working with of the region and local Medical Teams in partnership in global medical governance in supporting the implementation of medical governance guidance principles and ensuring compliance with Sanofi global and/or local standards. Providing support in operationalize Strategy and Key processes/Systems related to Medical Affairs activities in line with Sanofi standards with and across teams. ​ He/ she will have a complete overview of local tools & processes to enable smooth implementation of Group led initiative.

This includes but is not limited to the following:

• Support Management of the Governance standards by establishing frameworks, guidelines, policies, and processes.
• Ensure Regional Medical Governance Database (detailed information by country) is maintained for countries in region by working with local Medical Contacts and RMGO for Region.
• Support strategic and operational guidance in a plain language for medical activities.
• Acts as a subject matter expert for some defined Governance and compliance aspects of region and educate or train other stakeholders on the process whenever required.
• Supports in identifying potential areas to harmonize and create efficiencies across countries in the region and work closely with local & global teams to address if any gaps identified.
• Participate to the creation of new processes & tailoring of existent ones in accordance with business imperatives and compliance standards.
• Supports Medical team in cross functional projects to continuously improve Sanofi standards, policies, guidelines, and systems.
• Supports local medical teams in identifying, managing medical local risks, and development of Risk plan to address risks identified, working in partnership with Compliance Officer within country and with other medical governance team members (global and local)
• Identifies and escalates quality and compliance risks related to assigned regions and proposes mechanisms to mitigate risks.
• Participate as required on with local medical staff as necessary on the internal control and E&BI monitoring exercise and in case of audit or inspection. 
• Monitors internal controls to measure compliance and supports internal audit outcomes.
• Works with Global and Local contacts on CAPA resolution following audit or inspection findings and ensures completion.
• Supports Country site visits and internal or external audit/inspections as needed to ensure local implementation of Company Medical Standards and Regulatory requirements.
• Share the best practices across the region including training, responses to inquiries, escalates requests as needed for appropriate responses.  

• People: (1) Maintain effective relationships with stakeholders (local and global); (2) Work closely with all the relevant global medical vaccines team ( such as Medical Operations & effectiveness team, Medical Excellence and Governance, Medical franchise teams, B&OS Events team as needed); (3) Collaborate when applicable with all relevant internal stakeholders, such as Legal, Ethics and Business Integrity, Com Ops, Public Affair, R&D, CMO, Pharmacovigilance, Quality and Internal control/auditors ;
•  Performance: (1) Supports in managing medical governance requirements in the region and adhere to the compliance requirements; (2) manage the compliance during policy change or regulatory changes or system changes by providing a Governance framework (3) Support the implementation of global processes by adapting the local requirements and compliance; (4) Ensure that global and local compliance methodology and programs are integrated and well documented to demonstrate program effectiveness

• Process: (1)  participate to the development of the Governance standards, frameworks for Medical affairs in the region and educate country or other relevant stakeholders on adherence; (2) harmonize the governance process or standards across countries in the region; (3) Create and develop a systematic quality compliance and controls (4) Assists in identification and escalates quality compliant risks and work on mitigation as directed (5) Supporting country audits (if required) on global process & work on any identified Global CAPA.

• Stakeholders: (1) Regional Medical Governance Officers including Global Lead RMGO,(2) Medical, Excellence and Governance team, country / regional medical teams; (3) Legal, EBI, Public Affair teams (4) R&D, CMO, Regulatory & PV teams G (5) Quality And other functions to support medical governance & compliance

About you

• Experience: 7+ years of experience in Managing projects in medical domain with an operational knowledge in QA, Regulatory, EBI & international regulations & standards
• Soft skills: Strong administrative and organizational skills in complex set ups with agility, communication
• Technical skills: Basic MS Office skills, Smartsheet & Project Management
• Education: Bachelor/Higher Degree/ Medical Doctor
• Languages: Excellent knowledge of English language (spoken and written)

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!