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Bristol-Myers Squibb

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4.0

based on 128 Reviews

122 Bristol-Myers Squibb Jobs

Trial Supplies Manager

BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

4.0

based on 128 Reviews

3-6 years

Hyderabad / Secunderabad

1 vacancy

Trial Supplies Manager

Bristol-Myers Squibb

posted 1d ago

Job Role Insights

Flexible timing

Key skills for the job

Logistics Project Management Packaging Offer Negotiation Forecasting

Job Description

Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug's development with minimal supervision

Roles And Responsibilities

Collaborates with internal Global Clinical Supply Chain (GCSC) teams and external Customers and Service Providers, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors and Medical to ensure all needs are met

Proactively defines, plans, and communicates the clinical supply chain strategy in support of global clinical studies to promote optimal use and alignment with study and corporate goals

Demonstrates strong knowledge of GCSC processes when presenting at cross-functional meetings

Responsible for identifying and supporting strategies for continuous improvement, both departmental and/or inter-departmental

Influences clinical and development timelines, study design and country selection

Directly responsible for reviewing and providing input to draft clinical protocols, communicating timelines and investigational product strategies to study and cross-functional teams

Develops supply forecasts for studies through evaluation of the clinical development plan and protocol analysis

Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines

Issues Manufacturing and Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with Clinical Development team, Chemistry, Manufacturing Controls (CMC) team and CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements

Monitor use date of investigational drug product for assigned protocols

Support use date extension activities, such as generation of Use Date Extension (UDE) memo, and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites

Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account country Regulatory and QP Release requirements

Participates in development, review and approval of Interactive Response Technology (IRT) specifications

Develops investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements

Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings and any other relevant meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies

Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements

Attends meetings with vendors and generates purchase requisitions as needed

Actively supports the budget process by maintaining supply and demand estimates for assigned studies in Budget Tool and by regularly reviewing and updating against revised clinical plans

Acts as the main Clinical Supplies contact person for the assigned compound and associated studies, leading communications regarding global supply strategy with study team as appropriate

Supports associated actions stemming from change controls

In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings to support inspection readiness activities

Enters product complaints and deviations in appropriate system and works with PDQ for investigation and resolution

Manages conflicts/issues with internal and external partners and customers

Writing of departmental procedural documents as applicable

Performs other tasks as assigned

Skills and Qualifications

Minimum 2 years Pharma industry related Experience Minimum 1 years Clinical Supplies/Development with global experience or equivalent Experience An equivalent combination of education and experience may substitute

Moderate / Strong knowledge of the global drug development process and global regulatory requirements

Proficient and strong analytical skills

Strong communication and negotiation skills

Proficient and strong Project management skills

Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i e Manufacturing, Packaging Labeling, IVRS, Logistics, Quality, Stability, etc Proficient knowledge of import / export requirements

Proficient/Strong knowledge of IVRS and CTMS systems

Proficient / Strong knowledge of industry technology

Applies and drives Forecasting and Planning activity as it relates to protocol

Ability to build/drive internal team consensus

Translates broad strategies into specific objectives and action plans

Team and individual leadership (leads courageously)

Oral and written communication (fosters open communication)

Conflict resolution (manages disagreements)

Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships)

Influencing (manages influencing others)

Coaching and mentoring (fosters teamwork)

Around the world, we are passionate about making an impact on the lives of patients with serious diseases

Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues

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 with the resources to pursue their goals, both at work and in their personal lives

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway

You could be one step away from work that will transform your life and career

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary

Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work

This structure includes site-essential, site-by-design, field-based and remote-by-design jobs

The occupancy type that you are assigned is determined by the nature and responsibilities of your role

Site-essential roles require 100% of shifts onsite at your assigned facility

Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility

For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture

For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles

Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer

If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bmscom

Visit careers

bmscom/ eeo -accessibility to access our complete Equal Employment Opportunity statement

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities

As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers

bmscom/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

Employment Type: Full Time, Permanent

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What people at Bristol-Myers Squibb are saying

3.1

Rating based on 4 Manager reviews

Anonymous · Research & Development in Hyderabad / Secunderabad

Likes

Compensation and benefits are quite good. The health related benefits are better than other employers.

Salary - Excellent

+1 more

Dislikes

There is no growth and learning as there is no career ladder. Employees in US treats Indians as slave and assign work that is of no visibility to us. They take credit of our work and show it on global portal. For future growth discussions managers comment on the current compensation and says we are paying you better so do what is ass..Read More