Global Submission Management

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.

Key Responsibilities and Major Duties

Responsible for the planning and the preparation of the clinical trial applications (CTAp) for programs conducted mainly in the EU with focus on Substantial amendments, coordinating updates at program level. The specialist will gain expertise to progressively be assigned to initial applications of increasing complexity.

Assist GSM - CT with the preparation, distribution and tracking of the core Clinical Trial Application dossier and subsequent amendments (IB/CMC at program level revised protocols). Assist GSM - CT with Verity (HA submission and approval Tracking system) by creating events/activities/registrations/running reports etc 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. Escalate to study teams and GCT-SU senior roles observed trends and issues that may impact timely and successful study approval and execution Expected to be able to coordinate updates within a Program. Support continuous improvement and compliance initiatives Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates Support GSM - CT in creation of End of Trial and tracking, as well as distribution of CSRs to Country Applicants. Contributes to other requirements as appropriate to allow proper functioning of the GSM - CT.

Support implementation of the EU CT REG Portal.

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

Ensure timely support for Investigator Sponsor Research Trials (ISRs) at EU level. Create cross Reference Letters and when not possible coordinate submission of CMC documentation with local Regulatory.

Competencies - knowledge, skills, abilities, other

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

2 years of clinically related or relevant experience:

knowledge of the pharmaceutical industry (thorough understanding of ICH-GCP guidelines) and of the pre-clinical, clinical, regulatory and commercial components, the drug development process and the impact of regulations worldwide.

knowledge of general clinical research including project management issues, important milestones and strategies to ensure timelines are met.

experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry. EU process and package content is an asset.

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

previous experience working in an international team environment within a matrix organization Fluent in English (written and spoken)

Proficient use of other applications and software (Excel, Powerpoint, eConferencing, etc) to fully support processes.

Demonstrates flexibility to work simultaneously on projects of different therapeutic areas and different countries. Communicates effectively using excellent verbal and written skills with both internal and external key stakeholders; coordinates information and document flow to and from both internal and external customers.

Works well in a team environment, collaborates effectively with internal groups and demonstrates a can do approach. Utilizes effective problem-solving approaches and independently follow-up and resolves outstanding issues, within deadlines to achieve key deliverables.

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.

Company: Bristol-Myers Squibb

Req Number: R1524603_EN

Updated: 2020-04-28 00:00:00.000 UTC

Location: Princeton,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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