Global Clinical Trial-Submission Unit Specialist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Global Clinical Trial-Submission Unit (GCT-SU) Specialist:

This role has two key responsibilities: 1) Provide support to Senior specialist in CTAp preparation activities 2) Optimally prepare and distribute the final CTAp and subsequent Substantial amendments to country applicants for submission to Ethics Committees and Competent Authorities:

Ensure consistency of the Clinical Trial application across projects, studies and countries.

Actively participate in Program level CTAp Tracking Meetings, led by senior role, in preparation of the CTAp 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, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations.

Comply with the use and maintenance of the available planning & tracking tools (e.g. Verity - HA submission and approval Tracking system) to generate reports and track the CTAp content and associated dates.

Escalate to study teams and GCT-SU senior roles observed trends and issues that may impact timely and successful study approval and execution

Contribute to the Country Requirements Repository by collecting and sharing additional country requirements.

Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GCT-SU.

Expected to be able to coordinate updates within a Program.

Support continuous improvement and compliance initiatives.

Knowledge on Country Requirements.

Knowledge Desired:

Knowledge equivalent to that attained with a Bachelor's degree in Life Sciences, Allied Health, Pharmacy, Nursing, a Master's degree is preferable

2-4 years of clinically related or relevant experience

Fluency in English

Experiences Desired:

Experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry.

Experience in effective implementation of clinical plans/documents and document preparation.

Demonstrated success in using oral and written communication and presentation skills to influence, inform or guide others.

Ability to work in multiple parallel projects and to share learning.

Previous experience working in an international team environment within a matrix organization.

Experience in managing technology for information and communication tool

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com