CT Disclosure Manager at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, HealthcareIndustries

Requirements

BA/BS or MA/MS in scientific or medical field
3-4 years of transparency experience and 6-8 years relevant work experience in a scientific or medical field with BA/BS
Project and stakeholder management experience
Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies
Familiarity and comfortability working with and discussing scientific data
Demonstrated ability to work independently and seek out support when needed
Exceptional written and oral communication skills
Strong organizational skills with the ability to multitask and prioritize

Responsibilities

Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations
Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements
Perform quality control of redacted documents
Provide vendor oversight to support document redaction, as appropriate
Manage and track redaction book-of-work; compile and report on volume and performance metrics
Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
Provide operational support to CT Results Managers, as required
Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements
Communicate with internal and external stakeholders to improve on processes and manage unmet need
Train new staff and develop job aids, work instructions, and user guides, as needed
Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations

Skills

EMA Policy 0070

Health Canada PRCI

EU Clinical Trial Regulation

Document Redaction

Quality Control

Clinical Trial Disclosure

Regulatory Compliance

Biostatistics Collaboration

Medical Writing

Submission Management

Vendor Oversight

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.

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