Specialist at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

BA/BS degree, science/technology field preferred
1-2 years pharmaceutical experience
Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities
Proficient use of CTMS, Tracking systems, Excel trackers to generate reports and track CTA content and associated dates
Communicates questions and issues as they arise

Responsibilities

Manage the signing of clinical trial documentation such as powers of attorney, coordinating many signings at the same time
Provide support to the Submission Senior Specialist/Manager in CTA preparation activities for initial filings and start-up activities, protocol amendments, end of trials, and CSR distributions
Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs
Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications
Ensure consistency of the Clinical Trial application across projects, studies, and countries
Actively participate in Program/Study level CTA Tracking Meetings, led by Senior Specialist/Manager, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations
Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure Clinical Trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations
Comply with the use and maintenance of planning & tracking tools (e.g., Veeva - HA submission and approval Tracking system) to generate reports and track CTA content and associated dates
Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution
Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements
Support initiatives for innovation and simplification in processes to improve support to study teams and GSM-CT
Coordinate updates within a Program
Support continuous improvement and compliance initiatives
Utilize technology effectively to support the clinical trial application submission process
Contribute to other requirements as appropriate to allow proper functioning of the GSM-CT
Support implementation of the EU CT REG Portal from Feb 2022

Skills

CTA

CTIS

Clinical Trial Submission

Regulatory Affairs

Powers of Attorney

Protocol Amendments

CSR Distribution

EU Regulation

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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