Associate Manager - Study Review Committee Governance

Sanofi India Ltd; Hyderabad; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Sanofi India Ltd seeks an Associate Manager SRC Governance to lead governance for study reviews, SRC, and MRPTC processes. You will coordinate global and local stakeholders, prepare governance materials, and ensure audit-ready records in line with Sanofi policies.

The role requires 6+ years in pharma, strong leadership, and excellent English communication. It offers growth within Sanofi Business Operations and exposure to cross-functional teams globally.

Qualifications

• 6+ years experience in pharmaceutical/medical industry.
• Bachelor/Master’s in life sciences required.
• Excellent English language knowledge, written and spoken.

Responsibilities

• Set up governance processes for study reviews and committee meetings across ESRs, Phase 1 studies, Global Health Studies and MRPTC.
• Coordinate stakeholders for SRC and MRPTC meetings, ensuring high-quality proposals.
• Capture comments, circulate decisions, and provide audit-ready documentation per Sanofi policies.
• Lead Phase I SRC governance activities and maintain interfaces between local and global teams.
• Manage the SRC/MRPTC agenda, minutes, follow-ups, and risk mitigation steps.

Skills

Leadership

Strategic thinking

Stakeholder management

Project management

Communication

Independent & team work

Education

Bachelor/Master’s in life sciences

Job description

Associate Manager SRC Governance

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.
• 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

Requirements

• 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/ Master’s degree required – life sciences
• Languages: Excellent English language knowledge – written and spoken

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.

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Experience Level Mid Level