Job title: Associate Project Manager – SRC, MRPTC & Phase 1 Governance
Company: Sanofi
Job description: Mission statements Study Review Committee * Study Review Committee also known as SRC reviews and approves all Medical and Market Access studies, independent of study classification grouping, whether they are conducted at Global or Local Level to d
Mission statements Study Review Committee Study Review Committee also known as SRC reviews and approves all Medical and Market Access studies, independent of study classification grouping, whether they are conducted at Global or Local Level to demonstrate robust scientific rationale for investment and comply with Sanofi procedures for scientific approval. General Medicine has 4 Global SRCs covering – Company Sponsored Studies & Externally Sponsored Collaborations (CSS & ESC), Phase 1 Studies, Investigator Sponsored Studies (ISS) and Global Health Studies who conduct meetings as per the SRC operating model to SRC Governance program manager’s primary responsibility is to program manage the new SRC operating model established to manage the review approval process effectively, ensure the action register is maintained in coordination with stakeholders, schedule periodic SRC review meetings to discuss ‘unresolved issues’ recorded in the action register and document the decisions. Effectively managing the prerequisites for SRC review approval meetings helps to the team to focus on necessary issues and make decisions appropriately 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, Phase I oversight Monthly review meetings: 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 Budget management: Secure planning, follow-up and reporting of planned and actual costs for Phase I studies working closely with local/global medical and finance. Make necessary budget entries and updates in Smartsheet. Smartsheet maintenance: Ensure system maintenance at study level based on the monthly review meetings: study related information, timeline, and budget Collaboration SRC Chair, SRC Reviewers, SRC coordinator MRPTC Chairs, reviewers, and presenters Local Medical, HEOR, Market Access, CSU Global Medical HEVA Business Partner, CSO Segment Medical Commercial team as required Duties & Responsibilities People 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. Collaborate with the stakeholders to organize SRC and MRPTC review approval meetings and capture the decisions from the meeting Process Set up governance to review approval meetings for all 4 committee reviews – Company Sponsored Studies & Externally Sponsored Collaborations (CSS & ESC), Phase 1 studies, Investigator Sponsored Studies, Global Health Studies and MRPTC as per the established operating model Ensure the pre-requisites of the meeting are met, such as SRC intake form is submitted 10 business days ahead of the SRC meeting, 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. Same for MRPTC 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. Same for MRPTC 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 Participates in the other ad-hoc meetings as required Customer Liaise with study team, SRC and MRPTC reviewers both local and Global to manage the review approval governance Identify and align with key stakeholders prior to submitting materials to SRC and MRPTC Knowledge, Skills & Competencies / Language Leadership Strategic thinking and decision making Stakeholder management Project management Commit to Customers Ability to work independently and within a team environment Excellent English language knowledge – written and spoken Qualifications Bachelor/Master with 8 to 10+ years of experience in Pharmaceutical or medical industry 5+ years of relevant experience in Clinical Research Project Management Thorough Clinical research knowledge Requirements of the job Patient-focused demonstrates good common sense and compassion Strong administrative and organizational skills Experience with managing senior leadership and Business partners Ability to take initiative, work well under pressure and work with people from different functions Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint). Excellent written and verbal communications skills with demonstrated ability to convey critical and sensitive information in a highly professional manner At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Expected salary:
Location: Hyderabad, Telangana – Secunderabad, Telangana
Job date: Mon, 25 Apr 2022 22:16:50 GMT
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