Junior Submission Manager
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.
Junior Submission Managers are part of the Global Dossier Management ('GDM') group, supporting team members and vendors in the execution of the Global Submission Plan. They assist the team in tracking progress of all components for dossier submissions to health authorities. They interact with responsible parties to help ensure that components are received in a timely manner, and they track activity to assure quality results are produced.
Junior Submission Managers validate that regulatory guidelines are followed for electronic format, and review both submission ready documents and dossiers for compliance with these guidelines, confirming any issues with Submission Managers. The incumbent is required to build a strong working knowledge of global regulatory practices and requirements, and supports Liaisons, CMC, safety, and other regulatory functions as appropriate.
The Junior Submission Manager provides elementary subject matter expertise for dossier production and delivers advice and guidance with regard to regulatory and submission requirements, submission strategies, dossier content, and format. The incumbent is also a contributor to research activities for legal due diligence, document and dossier management for acquisitions, partnerships and divestitures, assisting in regulatory agency inspections, and other miscellaneous regulatory operational activities (e.g. US export waivers, translation document management, maintenance of US PDUFA products/establishment lists, etc.).
The Junior Submission Manager supports the GDM Submission Management team and provides back-up to colleagues as required.
- Elementary working knowledge of global regulatory practices, electronic submission guidelines and requirements
- Ability to coordinate multi-functional submission teams and track progress of dossier components to ensure timely execution of submissions.
- Ability to interact and negotiate with outside vendors on Global Dossier Management matters.
- Exhibit strong attention to detail, have good organization, communication, and collaboration skills, and multi-tasking competencies in order to work simultaneously on multiple projects.
- Ability to competently assess changes and make adjustments to plans and manage associated challenges; must be able to cope with submission timeline pressures and adverse conditions, demonstrating clarity, decisiveness and willingness to seek advice.
- Technological capabilities and technical savviness to work in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, Lync, Access, Documentum, eCTD viewers and web-based applications)
- Be able at times to work long hours in order to meet team and company deadlines; sometimes including nights, holidays and weekends.
- BA/BS in science/technology field with 3 years of pharmaceutical experience.
- Basic understanding of principles of regulatory submissions; level will commensurate with knowledge and experience.
- Experience with technology solutions and software used in the pharmaceutical industry
- Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work in a fast-paced team environment or independently is expected