Associate Manager SRC Governance

Our Team
Sanofi Business Operations (SBO) 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 . Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
The Sanofi Business Operations (SBO) is built to reduce reliance on external services providers and facilitate the development of internal expertise. The Sanofi Business Operations (SBO) will leverage untapped combination of talent pool.
Main Responsibilities
Committee review Governance team support to set up governance to review meetings for all 4 committee reviews for ESRs, Phase 1 studies, Global Health Studies and MRPTC as per the established operating model.

• Study Review Committee
• Primary responsibility is to Set up governance to review approval meetings for all 4 committee reviews - Company Sponsored Studies & Externally Sponsored Collaborations (CSS & ESC), ISS, Global Health Studies as per the established operating model.
• Identify the stakeholders required for the review approval meeting and organize stakeholder alignment pre-SRC meeting to ensure high quality, mature proposals are brought to the SRC and for improved meeting efficiency & decision making. Capture the comments and responses in the Action Register.
• Maintain and distribute documents along with Action register to the SRC reviewers and moderate the SRC meeting to discuss any unresolved issues in the Action Register, record the decision. Capture and circulate the decisions from the meeting.
• Prepare and provide documentation to support audit-related activities to ensure compliance with Sanofi policies & procedures at the local, regional, and global level.
• Manage temporary help as needed and participates in the other ad-hoc meetings as required
• Primary point of contact for study requestor i.e., local medical teams and global medical program, Global HEVA Business partners to manage SRC review program, process inquiries etc.
  

• Medico-Regulatory Pharmacovigilance Transversal Committee (MRPTC)
• Lead the conduct of the MRPTC including the preparatory meetings, minutes of meeting, follow-up, and coordination with local, regional, and global stakeholders.
• Collaborate with the stakeholders to organize MRPTC review approval meetings as per the established operating model and capture the decisions from the meeting
• Identify the stakeholders required for the review approval meeting and organize stakeholder alignment pre-MRPTC meeting to ensure high quality, mature proposals are brought to the MRPTC and for improved meeting efficiency & decision making. Capture the comments and responses and circulate the decisions from the meeting.

• Phase I SRC
• Set up governance to review approval meetings for all Phase 1 studies as per the established operating model.
• Ensure the key interface between the cross-functional local and global representatives: Local medical, global medical portfolio development phase I, local/global BEQ coordinators and CSO.
• Ensure planned timelines are met by successful planning and execution.
• Close follow up on and report of risks, challenges, and mitigation plans.
• Capture the comments and responses and circulate the decisions from the meeting
  

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People: (1) Maintain effective relationship with internal Sanofi stakeholders (2) Regular connects with Sanofi stakeholders and relevant teams and manages the team.

• Performance: (1) Effective and efficient management of assigned studies to complete on time
• Process: Adherence to timeline and quality target
• Stakeholders: (1) Identify and Align with key stakeholders 2) Liaise with relevant stakeholder for assigned task
• About you
• Experience: 6 + years experience in Pharmaceutical or medical industry and relevant experience in Clinical Research Project Management; Thorough Clinical research knowledge.
• Soft skills: Leadership; Strategic thinking and decision making; Stakeholder management; Project management; Commit to Customers; Ability to work independently and within a team environment
• Technical skills: Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint).
• Education: Bachelor/ Masters degree required – life sciences· Languages: Excellent English language knowledge – written and spoken