Submission Manager - Clinical Trials at Bristol-Myers Squibb

Warsaw, Masovian Voivodeship, Poland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical TrialsIndustries

Requirements

BA/BS degree in science/technology field preferred
5+ years relevant regulatory submissions experience and people management experience
Expert knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities
Assists in the development of short- and long-term goals for own workgroup in alignment with those of GSM and the R&D umbrella
Resolves problems/difficulties with the assistance of Sr. team members
Supports other functions as appropriate
Independently facilitate compound/study team meetings
Works independently and collaborates with other functional areas

Responsibilities

Collaborate with global and local stakeholders to define clinical trial submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines
Assess core submission deliverables to ensure compliance, prepare and distribute global CTA dossiers, and manage data required for EU CTIS and substantial modifications
Monitor and influence the regulatory assessment process, drive negotiations with stakeholders to resolve information requests, and communicate regulatory changes to ensure ongoing compliance
Manage and track queries, commitments, and submissions with health authorities, collaborate with subject matter experts for responses, and provide periodic status updates on commitments
Drive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams
Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information
Ensure consistency of Clinical Trial Applications across projects, studies, and countries, aligning with regulatory standards and best practices
Effectively communicate regulatory changes to the business to maintain compliance and support continuous improvement

Skills

Regulatory Strategy

Clinical Trial Submissions

CTA Dossiers

EU CTIS

Global Regulatory Compliance

Stakeholder Collaboration

Submission Preparation

Regulatory Assessment

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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