Responsibilities:

Regulatory Global IT Operations lead for Veeva RIMS

• Accountable for directing and leading the global IT operations of the Veeva Regulatory RIMS platform and IT support activities across the Regulatory organization at BMS.  
• Collaborate closely with the Regulatory business organization from a business relationship lead perspective and serve as the resident expert in the Enterprise Veeva IT Operations team at BMS on the following business processes supported by the Regulatory RIMS system: Critical Submission Planning and Tracking, Marketed Products Planning and Tracking, Investigational Products
• Serve as the Regulatory IT Lead and primary interface between business partners and technology vendors on demand management projects in order to analyze and validate published business requirements and turn them into functional solutions.
• Direct and Lead across multiple regional and global teams to ensure harmonization of global/regional Release Management of the Regulatory RIMS system.
• Establish and direct a strong working relationship with the IT Plan team in the Regulatory domain to participate in the development of a roadmap aligned with portfolio planning. 
• Work closely with strategic partners, providing the leadership necessary to synchronize business and IT Enterprise Veeva processes and ensure compliance with BMS policies and procedures. 
• Partner with Veeva to define additional Veeva opportunities at BMS and drive those opportunities to the platform, further enabling the Enterprise Veeva Platform model.
• Serve as the primary Operations Lead in Regulatory IT to business partners and technology vendors to discuss their business needs and explore advancement of solutions with vendors depending on current and future needs. 
• Lead and work closely with matrix teams from BMS and external vendors to ensure a smooth execution of support and demand management project activities.
• Manage a team of 8 people: 4 US based resources and 4 offshore resources, all outsourced operations analysts, testers and multiple vendor teams to execute on Veeva RIM demand management projects and release management.   
• Partner with IT Business Partner teams to develop road maps and identity investment opportunities to deliver new solutions

Life Cycle Management

• Manage and oversee operational financial budget 3 – 3.5 million annually. Take full ownership of and manage software license usage to ensure 100% compliance with contracted software license agreements. 
• Accountable to ensure that all budgetary targets are met or exceeded, and where possible identify and pursue further opportunities for savings or cost avoidance by utilizing automation and AI methodologies.
• Drive business performance through a highly effective and efficient demand management & release management process, delivering on all commitments.
• Ensure the demand management process develops a fully aligned and business-approved demand management portfolio per incremental release cycle, building more structured, strategic, and aligned relationships with business constituents in Regulatory.
• Serve as the resident IT Lead to provide oversight to Accenture and Veeva in the Regulatory space to ensure delivery of business-approved Operational portfolio commitments, critical releases, and other approved changes according to agreed time, budget, scope and quality.
• Ensure direct compliance with defined SDLC practices. Deliver on time, on scope, on budget, and with all requisite qualifications per SDLC.
• Drive business performance through delivering operations activities related to application and business operations support for the Regulatory RIMS system.
• Ensure effective change control leadership around the review and approval of change requests related to the Regulatory RIMS system.
• Ensure full and timely IT support to progress critical pipeline activities (ie., critical study filings, FDA submissions, String of Pearls acquisitions, divestitures), ensuring effective collaboration and coordination.

Compliance

• Take full accountability and ownership in the support of internal and health authority audits by representing IT as single point-of-contact for compliance-related matters (e.g., regulatory agency compliance audits, Corrective Action / Preventive Actions). 
• Fully accountable to ensure health authority and internal regulatory compliance and quality practices are met or exceeded.
• Ensure compliance with SDLC standards and ensure quality deliverables for maintenance activities.
• Directly lead and ensure timely IT coordination and support to address 100% of audit findings in accordance with agreed-upon time-lines.

Requirements:

• Bachelor’s degree in Computer Science, Information Technology, or related field, is required.

• Overall 10-15 years in Information Technology with 8-10 years of pharmaceutical experience or other relevant Vault and Regulatory processes
• Experience in Regulatory systems specifically Veeva RIMS is very desirable
• Strong leadership and decision making skills, with the ability to influence others
• Proven strong client management skills particularly with senior level 
• Ability to effectively manage multiple, complex initiatives and conflicting priorities
• Strong written and communication skills
• Demonstrated ability to build strong working relationships with a broad matrix team and ability to influence others and achieve results
• Excellent business and transaction processing skills
• Strong analytical and problem solving skills

Summary:

Execution of reporting, technical issue resolution, and exception-based inventory management. Should be responsible of proper on-time stock representation in all enterprise systems and ensure communication between our partners and BMS systems is properly functioning

Responsibilities:

• Ownership of functionality of distribution interfaces with the 3PL
• Reporting and assessing KPIs/ metrics
• Resolving stock issues, write-offs, reconciliations
• Primary accountable of managing inventory accuracy in the market and all stock exceptions on behalf of managers
• Supporting budgeting, reporting, audits as per BMS requirements and business process as required providing the appropriate analyses to Distribution Managers
• Review detailed items in 3PL contracts, ops manuals, SOPs, GDP compliance, and business reviews to provide comprehensive overviews across regions on specific topics
• Liaises with In-market Logistics Solutions and Regional Logistics role for providing relevant analyses and data to support their initiatives and evaluate scenarios
• Can act as SME in cross-functional forums in relation to their scope of responsibility
• Can act as back of for certain Distribution Managers during their absence in order to enable periodic processes or represent the GLS organization in different forums

Qualifications:

• Language (English + Spanish) and travel flexibility
• Logistics expertise and experience: required for executional management of 3PLs
• Must have 1-3 years experience in dealing with systems implementations, interface maintenance and follow up and inventory control related activities
• Must have excellent communication skills and foster open communication within the organization: particular focus on team collaboration and knowledge sharing
• Preferable to have 1-3 year experience of interaction with external partners in technically specific topics
• Preferable to have good knowledge of the Guidelines on GDP of medicinal products for human use and of the EU Directives on the wholesale distribution of medicinal products for Human use

Additional professional and personal requirements include:

• Business Acumen:  Has a strong understanding of the key business drivers of the industry/organization.  Persuades others with fact-based judgments of the business situation.

• Executing for Results:  Maintains high standards of performance for himself/herself and others, and follows through on commitments.  Demonstrates integrity, and sticks to core values and principles.  Takes the long view, and when faced with challenging obstacles, persists over a significant period of time to achieve his/her agenda.  Conveys a sense of urgency, and drives issues to closure.  Makes timely decisions when a quick response is required and a number of possible alternatives are available.

• Building Relationships and Using Influence:  Establishes credibility and earns respect with a diverse set of internal and external stakeholders including senior executives, manufacturing and other functional leaders, regulatory professionals, contractors and other partners.  Is highly articulate, and makes arguments in a clear and compelling manner.  Is able to “get things done” without compromising principles.  Has excellent negotiating skills, and achieves win-win outcomes in difficult situations.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

The Pharmacovigilance Associate is a member of the Epidemiology, Safety Science and Analytics group which coordinates, tracks and analyzes medical safety assessments, surveillance and data in clinical development activities. 
The incumbent has a key role in tracking and following up on actions and responses of experts and other stakeholders, ensuring  that timelines, resources and information are coordinated and documented accurately and in a timely manner.

Summary:

The Pharmacovigilance Associate is a member of the Epidemiology, Safety Science and Analytics group which coordinates, tracks and analyzes medical safety assessments, surveillance and data in clinical development activities. 
The incumbent has a key role in tracking and following up on actions and responses of experts and other stakeholders, ensuring  that timelines, resources and information are coordinated and documented accurately and in a timely manner.

Responsibilties

• Supports Medical Safety Assessment Physicians (MSAP) in leading and coordinating individual cross-functional Medical Surveillance Teams (MSTs) and assigned sub-teams, such as Safety Data Review (SDR) Teams.
• Creates meeting agendas for MST and assigned sub-teams, and documents of decisions, conclusions, timelines, milestones and action items in team minutes.
• Identifies post-meeting actions, and ensures responsibilities and timelines are assigned and met.
• Assesses and appropriately elevates issues impacting key MST activities, milestones, documents to the appropriate Global Pharmacovigilance & Epidemiology (GPV&E) colleagues. 
• Leads, plans, organizes, and forecasts requirements and/or resources based on Book of Work and other upcoming tasks and activities for assigned product portfolio.
• Executes searches of the corporate safety database, J-review database and the worldwide literature, applying critical thinking and independent research skills to ensure the information is appropriate and usable.
• Applies medical, life science and general scientific knowledge and expertise to create and manage plans and budgets for designated projects.
• BS in Science preferred or 2 years of equivalent experience.

The Leads Discovery & Optimization Group leverages technology, innovation, and broad scientific knowledge to deliver comprehensive in vitro data packages to support all phases of drug discovery at BMS.  As an Associate Research Scientist within the Lead Profiling group, this individual will be responsible for routine execution of biochemical and cellular ADMET profiling assays to accelerate drug discovery and early development at BMS.  This scientist will have hands-on experience with biochemical and cellular ADMET screening assays such as protein binding, permeability, metabolism, transporters and drug-drug interactions, etc. The ideal candidate will have strong technical skills, good data analysis skills and will demonstrate a track record of rapidly driving high-quality data delivery.  The successful candidate will have a can-do attitude and a drive to proactively facilitate the continuous improvement of processes and culture.  

Duties/Responsibilities:

• Execute high throughput ADMET cell based and biochemical production assays and assure timely delivery of quality data
• Perform data analysis and publishing of ADMET suite data
• Carry out remediation/revalidation plans and trouble-shooting activities
• Maintain critical reagent supply and adhere to budget for assigned assay suites
• Ensure quality control to maintain high data quality
• Sustain lean processes to improve efficiency and lower costs
• Work collaboratively across LDO functional teams to ensure assay delivery

Qualifications:

• BS with experience in biochemistry, cell-biology or related scientific discipline
• Experience in biochemical and cell-based assay execution, with a background in quality control, and high-throughput processes
• Direct experience in the execution of high-throughput in vitro ADME studies is advantageous
• Strong written and verbal communication skills and demonstrated strength in a matrix organization
• Track record of successful multitasking and rapid execution

Summary:

•Translational Medicine Project Management is focused on providing effective and efficient project management of TM functions and teams to drive business performance. 

•Responsible for project management of the International Immuno-Oncology Network (II-ON) core team, a cross-functional team responsible for the implementation of BMS internal and external research of novel immuno-oncologic agents in collaboration with a network of academic research centers. The II-ON core team is accountable to the senior leaders of the Immuno-Oncology Oversite Committee (IOC). 

•Provide all project management support to the II-ON core team and IOC and works closely with the Research Liaisons to ensure optimal execution against the plan.

Responsibilities:

Translational Medicine Project Management is focused on providing effective and efficient project management of TM functions and teams to drive business performance. 

• Responsible for project management of the International Immuno-Oncology Network (II-ON) core team, a cross-functional team responsible for the implementation of BMS internal and external research of novel immuno-oncologic agents in collaboration with a network of academic research centers. The II-ON core team is accountable to the senior leaders of the Immuno-Oncology Oversite Committee (IOC). 
• Provide all project management support to the II-ON core team and IOC and works closely with the Research Liaisons to ensure optimal execution against the plan.
• Support joint development teams across TM, especially Pharmacodiagnostics (PDx), effectively working with the Development Team and Translational Medicine Team Project Manager counterparts to ensure aligned development plans and coordinate execution
• This role will sit in CNJ and be a member of the TM, Discovery and Product Development (PD) Strategy & Operations Leadership Team.
• Add strategic value to TM by deriving insights and have the ability to execute actionable projects against those insights
• Anticipate risks and identify issues with the ability to troubleshoot and create solutions, balancing portfolio and asset needs.
•  Build and manage relationships with key cross-matrix stakeholders.  Demonstrate influence across TM and R&D functional leadership
• Partner with Alliance Management to support key diagnostic programsThe project manager maintains all project timelines and is responsible for communicating changes to the approved plan.  
• Role is the central point of common information/communication across the IOC, II-ON sub-teams, Translational Medicine Senior Leaders and academic partners necessitating the need for strong stakeholder management skills.
• Responsibilities include creating and maintaining integrated cross-functional project timelines, preparing internal team documents, managing II-ON budget, authoring development plans and monthly reports.
• Rapid identification and transparent communication of risks as well as competency to resolve project issues are key expectations
• Alignment of TM development strategies across the R&D portfolio
• Facilitate connectivity with early/late Development and Commercial project teams, governance and other key functions
• Support strategic indication-specific PDx Development programs for timelines, risk management, and milestones.  The Project Manager utilizes a variety of project management tools to build and sustain high-performing cross-functional teams for delivery of critical milestones, e.g. technical validation, regulatory activities, pivotal trial requirements for clinical validation, and commercial planning
• May support strategic indication-specific joint technical teams with diagnostic partners effectively working with the Development Team and Translational Medicine Team Project Manager counterpart to ensure aligned development plans and coordinate execution.

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

• MS, MBA, PhD, PharmD, or other advanced degree in a physical or natural science with 7 or more years of experience in the translational medicine and/or pharmaceutical industry Familiarity with biomarker and diagnostic development and commercialization is desirable. 
• Requires an understanding of both scientific and commercial issues, as well as efficient resource utilization in a multi-project environment.
• Strong scientific background is a must
• Has experience driving project management and can partner well with key TMLT members
• Excellent oral and written skills is required
• PMP certification is desirable.
• Project management experience is required with working knowledge in the drug development process.
• Excellent cross functional communications skills and a decisive yet collaborative leadership style to drive results while managing relationships.
• Demonstrated ability to work effectively in a matrix team across multiple disciplines internal and external to the organization, as well as efficient resource utilization in a multi-project environment.
• Demonstrated ability to successfully and effectively collaborate, cooperate and work across boundaries.
• Proven agility in prioritizing and navigating competing demands.
• Strong influencing/persuasive skills with a demonstrated ability to influence different styles and individuals at different levels in organization.
• Strong engagement skills.

Understand credit, AR, cash application & collection policy and procedures, and execute in compliance with Global distribution Practices (GDP). 

Understand the full end to end order to cash life cycle in order to sufficiently perform customer collection  activities and resolve customer complaints/inquiries

Support the in-market BFS team to prepare annual/periodic credit review on all customers 

Monitor blocked orders due to credit and propose / approve (based on GOA) releases regularly  

Release blocked orders held for collection reasons based on customer situation and feedback

Seek business approval as needed to release orders/take appropriate actions 

Analyze AR balances for assigned customers and determine/prioritize collection activities as appropriate 

Identify appropriate customers and block orders in support of resolving past due collection issues 

Contact customers to prevent and resolve past due AR 

Match and apply payments to customer invoices 

Post payments to AR ledger and reconcile to daily cash receipts 

Open credit notes and apply to open items as appropriate, request other credits to be reimbursed 

Request and process credit notes as appropriate   

Manage Disputes related to Collections  

Execute dunning strategies 

Escalate collection issues to in-market BFS team as needed  

Propose write-offs of incorrigible debt / accounts for approval by the Local Team and Business Units 

Support regular customer account reviews with the business 

Prepare reporting  and documentation for consumption by other departments (e.g. aged debt, DSO, A/R ledger activity) and other KPI and SLA measures as required 

Support internal and external audits
 

KNOWLEDGE, SKILLS, and COMPETENCIES:
 Education/Experience:

 3+ years experience in collections or finance services activities 

Fluent in Italian and at least one other European language 

Pharmaceutical industry experience preferred
Functional: 

Collections / Order to Cash experience 

Strong interpersonal skills 

Knowledge of Accounts Receivables Ledger 

Ability to assess and promptly resolve problems 

Strong quantitative and analytical skills
Technical: 

Ability to use SAP (SD/FI) and other Order-to-Cash or finance applications 

Advance knowledge and use of office productivity tools (MS Office, Lotus Notes, etc.)

Events & Meetings Center of Expertise (EMCoE) Lead (D6)

POSITION PURPOSE

Pharmaceutical Meetings Management is one of the fastest growing capabilities. The EMCoE lead in the Events & Meetings team proactively ensures that the needs of the business are met through strong, engaged collaboration with our Healthcare Professionals (HCPs), Commercial, R&D and Medical colleagues.  They are an expert on the end to end Health Care professional interactions and meetings management process.  Close alignment to the Commercial Business within the local market is crucial in addition to supporting training and resources specific to Meetings Management across the multi-disciplinary team. 

Efficient meetings management and speed with HCP payments by the EMCoE team will enable incremental business performance through empowerment of the team to simplify  processes, technologies and develop local innovative solutions that will enhance the overall customer experience (both internal and external) at BMS meetings and events.  By demonstrating a strong value proposition to the Commercial business EMCoE will be able to deliver sustained long term operational cost savings without compromising efficiency. 

Major Duties and Responsibilities

• Implement the strategic imperatives set by WWC HCP Meetings and Congresses

• Lead,  manage and develop the HCP interactions, congress and events team in accordance with strategies set by the WWC HCP Meeting and Congress leadership team
• Actively partners with matrix leadership such as Strategy and Ops, Commercial, R&D and Medical  and Legal & Compliance  to ensure business needs are met
•  Drive the strategy and implementation for continuous improvement with standardization, process simplification and automation to elevate the customer experience.
• Grow and develop an evolving customer focused organization internally and externally

• Assess and analyze data to develop insights and KPI measurements to facilitate execution of long term business plans and growth.

Where no D5 role is in place

• Drives the implementation and training of the end to end meetings management process and any new systems for the cross functional team end and ensures that the training materials are up to date

KNOWLEDGE, SKILLS, and COMPETENCIES:

Education/Experience

• Insight and experience of having worked in a sales/marketing environment  or experience in a commercial customer facing role with a minimum of 4-6 years’ experience
• Business or Technical undergraduate degree preferably an MBA
• Experience of leading and managing complex projects in a changing business environment
• Fluency in English and home country language (home country language requirement dependent on market)

Functional / Technical

• Demonstrated team orientated approach with examples of diverse leadership
• Demonstrated ability to work independently and effectively in an internal and external matrix environment, with strong interpersonal and influencing skills
• Excellent written and verbal communication to facilitate relationships with direct reports,  peers and management
• Demonstrated ability to apply strong quantitative and analytical skills to provide business solutions with a customer-centric focus
• Demonstrated ability to Influence others to adhere to Company’s policies and procedures and to take actions; especially those over which there is no formal authority
• Demonstrated ability to coach and support others to achieve proficiency in defined systems and processes
• Solid experience in fast paced business environments

Development Value

• Opportunity to develop team management, organizational management and direct line leadership experience
• Opportunity to learn and improve the Meetings & Events channel to achieve the WWC and local market business strategy.
• Opportunity to share, learn and collaborate  amongst the World Wide  Commercialization team
• Opportunity to enhance process re-engineering, change management and communication skills working across the matrix with a wide range of business partners
• Opportunity to be part of an energizing, innovative and supportive culture with colleagues located in the markets, Capability Centers and in HQ.
• Opportunity to directly impact customer experience and development of resources
• Opportunity to develop an expert understanding of the changing healthcare environment and the customers within it
• Opportunity to learn program management such as demand management (who uses the service), performance management (do they like the service) and continuous improvement (what should be done to improve)

BMS BioPharma Behaviors required

• Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.
• Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
• Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
• Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.

Major Responsibilities:
- Assist Regulatory manager for implementing and delivering regulatory submission and approval, and maintenance for new products / projects in assigned therapeutic area within agreed timeline.
- Ensure regulatory compliance with government policy and company required SOPs
- Establish and maintain close relationship with CFDA/ CDE/ NICPBP/ Shanghai FDA/ Shanghai DCI and other appropriate regulatory agencies and under manager’s guidance have a close/ effective communication with relevant regulatory agencies to consult regulatory strategy, determine status and facilitate the approvals of applications submitted to CFDA.
- Conduct scientific discussion under guidance of supervisor with relevant external and internal scientific functions locally and globally, specifically, Global and China Clinical Research, global CMC and GRS Operation, Pharmaceutical Development, Pre-Clinical, etc.
- Maintain good knowledge on general/product specific scientific and regulatory requirement / process
- Maintain strong working relationship and communications with cross-functions to provide regulatory information and support

To conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits, of investigator sites, vendors, partners and internal systems. To act as project-specific liaison between GQRC-CT&S and key stakeholders, including Global Development Operations and Global Regulatory and Safety Sciences personnel, monitoring the status of the projects to plan audits and assuring GQRC-CT&S leadership is informed. To host CFDA inspections at investigators sites and in-house.

Leading business monitoring team to implement and conduct a risk-based Compliance Monitoring Programme

Establish monitoring activity KPIs and communicate accordingly the results of the KPIs, major observations and trends to Business Units/Functions, legal/compliance, BCF and other stakeholders.  Propose mitigation solutions and escalate when necessary