Document Senior Specialist at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Minimum of a bachelor’s degree
3+ years' experience in the BioPharm/Pharmaceutical/Cell Therapy industry
Cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT) is preferred
Experience with demonstrated knowledge in quality and/or compliance discipline with in-depth knowledge of cGMP requirements and global health authorities’ regulations
In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret, apply and implement
Experience in negotiating and influencing skills in a matrixed organization
High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas
Demonstrated ability to work independently with oversight from manager
Ability to identify, manage, and/or escalate issues and risks to timelines
Fluent in English, with proven professional working proficiency in English for reading, writing and speaking

Responsibilities

Facilitating site procedural documents across areas of the QMS Framework and in association with electronic systems that support maintaining the QMS, including document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement
Responsible for compliance assessment of procedural documents against Global Procedures and Policies
Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to quality systems and document management
Serves as the site Subject Matter Expert for procedures and their QMS and provides cross site support for a variety of different document management systems and process
Support strategic initiatives and continuous improvement projects related to QMS
Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes
May be required to effectively manage projects, escalate issues as necessary and identify/meet key milestones
Work with guidance to manage the development of site procedural documents and, seek input as needed
May be required to be a representative for global document management initiatives and projects
Support site inspections and audits
Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies
Collect metrics to identify trends and take appropriate action
Responsible for communication of procedural document status to businesses
Maybe required to support the implementation and/or maintenance of additional QA Systems, which may include (but is not limited to) Documentation, Change Control, Quality Risk Management, Product Quality Complaints and Annual Product Quality Reviews
Support the completion of investigation/CAPA activities as required

Skills

QMS

Document Authoring

Document Review

Compliance Assessment

Electronic Document Systems

Continuous Improvement

Project Management

SOP Management

Quality Procedures

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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