Job Description

Position Details

Job Title:

Project Manager - Supply Outsourcing Coordinator (SOC)

Direction and Global Business Unit (GBU):

Direction: Medical Operations

GBU: Specialty Care, General Medicine, Vaccine

Geographical Remit of Role:

India

Location (based out of):

Hyderabad/Mumbai

Reporting to:

MedHub Projects Lead

Functional Reporting to (If applicable):

Not Applicable (NA)

Manager Position:

No

Supervises (Direct and Indirect):

Direct: NA

Indirect: NA

Customers:

Internal & External: -

GBU Medical Operation teams in charge of ESR, MAP, Humanitarian; R&D (IPTA2IP); CMO team; Global Regulatory Manager; Global IA and Distribution Quality Manager, iCMC Demand Supply Leaders; Clinical Supply Chain Operations; Project Operational Leader; Global Finance; Global Legal & Supply Procurement

and other functions as per supply outsourced activities needs

Valid From (date):

May 13, 2022

Purpose

• The Supply Outsourcing Coordinator (SOC) is accountable to develop and maintain sustainable operational process and relationship with the Contract manufacturing organization (CMO) in outsourced Medical supply chain activities. SOC scope includes External Sponsor Research (ESR) study requiring commercial product supply, Managed Access Program (MAP) product supply for structured program and single patient request (when outsourced), Individual Post Trial Access to Investigational Product (PTA2IP) product supply management (when outsourced), Humanitarian program and associated distribution activities

This includes but is not limited to the following:

• Set up and lead outsourced supply management, from supply forecast to supply delivery to sponsor location/investigational sites, including packaging and labelling if applicable, with Medical Operations, Industrial Affairs/Distribution functional teams, Clinical Supply Chain Operations and CMC (depending on related Medical activities)
• Get oversight of outsourced supply management for medical operations (e.g. Tracking of the vendors KPI, Periodical review of invoices
• Ensure outsourced supply activities is appropriately build in Sanofi and CMO tools as to maintain full tracking/chain of custody allowing proper and efficient supply/resupply of product to Health Care Professional.
• Manage Contract manufacturing organization
• Identify and manage deviations and risks associated with management of products Quarterly business review of the vendor in collaboration with procurement and quality

Performance Standards: Duties & Responsibilities

Key Areas

Action Areas, Deliverables and Outcomes

Weightage

People

Support the team with CMO (Request for Proposal) and Technical Conditions completion Represent Medical Functions at decision making committee for supply matter (e.g. Study review Committee, Franchise Global Medical Team) specific therapeutic area monthly Global Demand Review Represent GAP on supply/manufacturing discussions and communicate as appropriate with all internal groups regarding adequate supply and issue resolution Serve as primary contact for ad hoc requests from various Business Unit functions and Local/Regional teams for humanitarian forecast data and shipment information

Performance indicators

Feedback from stakeholders (end customers, medical teams) on overall satisfaction

15%

Performance

Evaluate the service level provided by the vendor. Report data on CMOs' KPIs and metrics, update and distribute dashboards Lead and manage continuous improvement initiatives, in collaboration with Lead Humanitarian Program Operations, Lead Humanitarian Programs and Lead Operations & Efficiency for Global Access Programs and Medical Operations

Performance indicators

Accurate preparation, analysis and reporting as per requirements Application of internal control policies and procedures No audit findings Adherence to timeline, quality target

40%

Process

Perform supply planning & order management activities including cross-checking orders against forecast and management of order backlog. Track inventory and replenishment planning. Monthly shipment reconciliation; includes detailed review of shipments, identification, and resolution of discrepancies. Reconcile discrepancies between demand and financial forecast Work closely with Global Supply Planning team to ensure that for any product request the supply is secured Manage supply planning & delivery commitments for quantities & timeliness in accordance with the supply license agreements Partner with Global Medical Operations to manage order backlogs; includes liaising with customer service, problem solving and interaction with local markets Provide periodic static data extraction and validation for integrity and consistency; ensures data updated in relevant supply chain systems Owner of program / study demand forecast in Kinaxis; includes data entry, alignment with open orders and financial plan and communication with local/regional teams to understand demand drivers, identify gaps and ensure resolution, etc. (Purchase Order initiation process might differ per GBU specific process) Support Global Medical Operations with financial planning activities including development of financial plan (3x per year), quarterly landing exercise and detailed year end shipment tracking Identify, communicate, and escalate root causes of any variations to the program / study forecast

Performance indicators

Adherence to company policies and procedures Feedback from stakeholders (end customers, other teams) on overall satisfaction Observations in case of audit/inspection

30%

Customer

Work closely with GBU Medical Operation teams in charge of ESR, MAP, Humanitarian, R&D - Development team in charge of IPTA2IP, CMO team, Global Regulatory Manager, Global IA and Distribution, Quality Manager, iCMC Demand Supply Leaders, Clinical Supply Chain Operations Project Operational Leader (during transition phase), Global Finance, Global Legal & Supply Procurement And other functions as per supply outsourced activities needs, Validation in invoice, Coordination of RFP distribution, Coordination and validation of technical conditions and may be other points regarding medical devices

Performance indicators

Feedback from stakeholders (end customers, other teams) on satisfaction with services provided

15%

Pre-requisites

Knowledge, Skills & Competencies / Language

• Minimum Amount of Job-Related Experience:

• Excellent written and verbal communications skills with demonstrated ability to convey critical and sensitive information in a highly professional manner
• Sound knowledge of Outlook, Word, and PowerPoint
• Advanced skills in Excel
• Sound knowledge of Smartsheet and Kinaxis are considered assets
• Sound knowledge of project management tools
• Understanding international regulatory requirements related to supply management
• Understanding QA release procedures for clinical and commercial products
• Good understanding of patient insight/unmet need & Sanofi strategy.
• Excellent organization, planning, and project management skills.

Qualifications

Education

• Bachelor's degree (engineer, PhD, Pharmacist) or higher
• Previous experience in supply chain management and vendor management
• GDP/GMP certification is a plus

Professional expertise and experience

• 9+ years' experience managing projects in supply chain activities or oversight experience - in matrix organization.
• Affiliate/operational experience is a plus.

Languages

• English (excellent in written and spoken language)

Any other requirements of the job

• Experience in Project Management and Supply coordination activities

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.