Document Coordinator

4 weeks ago

Hyderabad Telangana, India Bristol-Myers Squibb Full time

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Position Summary /Objective**

To create and coordinate the development and finalization of the operational deliverables for FDA submissions.

**Position Responsibilities**
- Partners with the Submissions Document Manager with preparing and performing a quality check on Clinical submission deliverables.
- Drives the development and finalization of GDO protocol-related submission deliverables to, ensuring requirements and targets are met according to timelines and quality expectations.
- Contributes toward standardization and efficiencies for the GDO protocol-related submission deliverables.
- 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.
- Proactively analyzes and drives efficient problem solving within team's control.
- Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items.
- Demonstrates strong project management skills.
- Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template).
- Demonstrate understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
- Manages interactions with senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents.
- Other duties as assigned to support Clinical Trials.

**Degree Requirements**

Minimum of a bachelor’s degree in Life science, Business Administration, or equivalent experience. BS/BA Degree with approximately 4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 2 years should be in the pharmaceutical, biotech or CRO environment. Advance degree a plus.

**Experience Requirements**
- 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.
- Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.

**Key Competency Requirements**
- 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.
- Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
- Ability to sustain high levels of performance in a constantly changing environment.
- Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
- Ability to prioritize work and assess risk to meet the needs of the organization.
- Demonstrated ability to work independently and seek out support when needed.
- Proactive, adaptable and able to modify personal and organizational work style to meet the needs of the business.
- Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
- Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.
- Strong understanding of protocol-related documents, and document management systems (e.g. CORE template).

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