Global Clinical Trial-Submission Unit (GCT-SU) Specialist
Bristol Myers Squibb
Braine L'Alleud, BE
18 uur geleden
source : DirectEmployers Association

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 BMS BioPharma Behaviors required + Passion : We pursue excellence to help patients prevail.
  • I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.

  • Innovation : We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
  • Accountability : We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
  • Speed : We act with urgency and agility. I work with a sense of urgency / I focus on what's important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.
  • 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.

    Data Privacy Link We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options.

    No matter the role, each one of us makes a contribution. And that makes all the difference. 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.

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