CT Submission Specialist at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Research & DevelopmentIndustries

Requirements

Minimum of a bachelor’s degree in Life science, Business Administration, or equivalent experience
BS/BA Degree with approximately 3-4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 1-2 years should be in the pharmaceutical, biotech or CRO environment
Advance degree a plus
1-2 years of relevant experience in clinical trial documentation management or a clinically related or relevant field
Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma
Experience in the use of industry Clinical Trial Master File Systems or equivalent (Experience with Veeva Vault Clinical preferred)
Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies
Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template)
Strong project management skills
Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals
Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure
Ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts
Demonstrated ability to work independently and seek out support when needed
Strong understanding of protocol-related documents, and document management systems (e.g. CORE template)

Responsibilities

Supports the GDO Submissions Document team with preparing and performing a quality check on Clinical submission deliverables
Supports the development and finalization of GDO protocol-related submission deliverables, ensuring requirements and targets are met according to timelines and quality expectations
Partners with the Clinical Trial Support Specialists (CTSS) for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents
Ensures documents are formatted appropriately and Submission Ready Compliant (SRC)
Identifies issues and addresses responses to issues. Escalates issues regarding document risks to appropriate stakeholders and/or functional management, to expedite resolution
Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items
Other duties assigned to support Clinical Trials

Skills

FDA submissions

Clinical submissions

Quality checks

Protocol deliverables

CSR appendices

Financial Disclosure Tables

Submission Ready Compliant

Document formatting

Clinical Trial Support

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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