Associate Director, TMF Compliance Lead at Bristol-Myers Squibb

Hyderabad, Telangana, India

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Expertise in TMF processes, Quality Management System (QMS), ICH E6 requirements, BMS Global Quality Standards, BMS Quality Management System, and ALCOA-CCEA principles
Knowledge of industry standards, evolving regulations, technology, and best practices in TMF and document management
Experience in leading global, cross-functional projects and collaborations with IT, third-party vendors, CROs, and external consultants
Ability to define migration strategies, control frameworks, monitoring methods, metrics, data analyses, and reporting mechanisms
Skills in building industry intelligence through training, conferences, and industry forums

Responsibilities

Lead and provide strategic direction across R&D functions to ensure high-quality TMF end-to-end processes for in-house and outsourced studies
Direct management of TMF Process Leads and TMF System and Business Lead, with matrix support to other department members including TMF Study Leads, Archival Leads, eTMF Operations Analysts, and the Central Upload and QR team
Collaborate with business stakeholders, including IT Business Partners, to define TMF migration strategies from CROs, third parties, and newly acquired companies
Work closely with the eTMF Operations Lead, eTMF System Business Owner, and IT Business Partners to ensure high-quality end-to-end document management and archival processes in line with industry standards
Lead global, cross-functional projects for optimizing the QMS and end-to-end TMF process, including archival and retrieval of study documentation
Maintain global processes, procedures, and training materials to ensure inspection readiness for completed studies in compliance with relevant standards
Support development and governance of global TMF processes through cooperation with relevant functions and TMF Process Leads
Identify named archivist(s) for paper and electronic records, ensuring required training, support, and coaching
Drive and support BMS audit/inspection readiness activities in collaboration with the Global TMF Process Owner and relevant functions
Liaise with Global Quality, Business Risk Management, Compliance, and functional leadership to implement mitigations and improvements
Set strategic vision and advise study teams on TMF inspection readiness activities
Define control framework for in-house and outsourced studies, including monitoring methods, data collection, analyses, metrics, targets, and reporting
Utilize metrics and trend analyses to identify, prioritize, and drive process improvements across the enterprise
Build and maintain industry intelligence and process expertise through training, conferences, and industry forums, channeling insights into BMS processes

Skills

TMF

eTMF

Compliance

Quality Management System

QMS

Document Management

Archival

Process Optimization

R&D

CRO Management

Migration Strategies

Cross-functional Leadership

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

Land your dream remote job 3x faster with AI

Try Jobo Free