General Medicines
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Job Title/Position:APM - Governance & Compliance

Job Profile: Medical Operations

Hiring Manager: Head of Clinical Operations, MAP & Medical Supply, Sanofi Business Operations

• Location: Hyderabad

• GBU: General Medicines

·       % of travel expected: Travel required as per business need

·       Job type: Permanent and Full time

About the job

Our Team:

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

Main responsibilities:

Associate Project Manager (APM) – Governance & Compliance is responsible to contribute to assigned GBU as a Subject Matter Expert in managing and establishing the Governance for medical programs viz. Access Programs, Support departmental projects and objectives according to agreed timelines and standards in the given area of proficiency and support adherence to compliance with GxP requirements.

This includes but is not limited to the following:

·       Improve the Governance standards for medical programs like Access programs, identifying bottlenecks and proposing enhancements to guidelines, policies, and processes.

·       Acts as a subject matter expert for medical programs and educate other stakeholders on the process whenever required.

·       Supports Medical Operations and efficiency team in cross functional projects to continuously improve Sanofi standards, policies, guidelines, and systems.

·       Supports in identifying potential areas to harmonize and create efficiencies across programs and work closely with local & global teams to address if any gaps identified.

·       Supports in managing medical risks, plan of actions and follow-up with different stakeholders.

·       Supports in coordinating the preparation of PV reports.

·       Supports MAP Access and Supply operations.

·       Create or develop periodic systematic quality process and review checks to ensure the compliance.

·       Monitors internal controls to measure compliance and supports internal audit outcomes.

·       Identifies and escalates quality and compliance risks related to assigned areas and proposes mechanisms to mitigate risks.

·       Supports the countries audits and inspections if required.

·       Works on CAPA resolution following audit or inspection findings.

·       Identify and manage deviations pertaining to medical programs.

·       Act as back-up coordinator for access and supply business operations.

• GBU: General Medicines

·       People: (1) Maintain effective relationships with stakeholders; (2) Work closely with Medical programs Governance Lead; (3) Collaborate with country medical teams, country supply chain, Global access teams, ESR governance lead, CMO governance teams & Business quality teams; (3) Serve as primary contact for medical programs governance & compliance

·       Performance: (1) Supports in managing the governance requirements across medical programs, and quality targets and adhere to the compliance requirements; (2) manage the compliance during policy change or regulatory changes by developing a systemic process (3) Contribute to continuous improvement initiatives, in collaboration with the Operations & Efficiency Leads and CMO ;  (4) Conduct the monthly/quarterly governance meetings with all stakeholders

·       Process: (1) Setting up the Governance standards for medical programs and educate country or other relevant stakeholders on adherence; (2) harmonize the governance process or standards across various medical programs; (3) Create and develop a systematic quality process & review checks for medical programs (4) Identify and escalates quality compliant risks and work on mitigations (5) Supporting country audits (if required) on global process & work on any identified Global CAPA

·       Stakeholders: (1) Medical Operations Prioritization Lead (2) Country medical, quality and supply chain teams; (3) Global Access Management Team; (4) Product Supply Lead; (5) CMO Governance Lead (6) Quality And other functions to support compliance & governance

About you

·       Experience: 8+ years of experience in Managing global Medical programs like Access programs, Relevant Quality Assurance experience in Medical operations

·       Soft skills: Strong administrative and organizational skills, Deviations & CAPA management, Audit Management

·       Technical skills: Basic MS Office skills, Smartsheet, QualiPSO

·       Education: Bachelor/Higher Degree

·       Languages: Excellent knowledge of English language (spoken and written)

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